For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
138134
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Enteritidis
Application Date
Application Number
138134
Application Product Name
Salmonella Enterica ser. Enteritidis
Application details
Product name:
Salmonella Enterica ser. Enteritidis
Product number:
93161
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138136
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Typhimurium
Application Date
Application Number
138136
Application Product Name
Salmonella Enterica ser. Typhimurium
Application details
Product name:
Salmonella Enterica ser. Typhimurium
Product number:
93163
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138135
Product/Active constituent Name
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application Date
Application Number
138135
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application details
Product name:
AviPro Salmonella Duo Live Vaccine
Product number:
93162
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Description of data provided:
Data no
248208
Title
Master seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248209
Title
Master seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248210
Title
Working seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248211
Title
Working seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261796
Title
Salmonella Enteritidis WSB _ CoA
Study date
11 December 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261797
Title
Salmonella Typhimurium WSB _ CoA
Study date
14 April 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248212
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248213
Title
Development of S.E. strain
Study date
March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248214
Title
Development of S.T. strain
Study date
May 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248215
Title
Expert report
Study date
16 December 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248216
Title
0-0115-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248217
Title
0-0061-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248218
Title
0-0062-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248219
Title
0-0060-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248220
Title
0-0063-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248221
Title
0-0110-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248222
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248223
Title
Batch record-200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248224
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248225
Title
Batch record-b052600-03
Study date
13 February 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248226
Title
Batch record-g039700-01
Study date
29 December 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248227
Title
GMP certificate
Study date
15 November 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248228
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248229
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248230
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248231
Title
Validation report 0-0063-VR-111-01
Study date
23 November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248232
Title
Validation report 0-0060-VR-92637
Study date
04 May 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248233
Title
Starting materials listed in pharmacopoeias
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248234
Title
Starting materials of non-biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248235
Title
Starting materials of biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248236
Title
In process control tests
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248237
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261798
Title
Specification vial
Study date
5 January 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261799
Title
Specification stopper
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261800
Title
Specification cap
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261801
Title
Batch-record Salm Duo
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261802
Title
Filling-closing procedure
Study date
30 September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261803
Title
Sealing procedure
Study date
30 May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261804
Title
Homogenous mixing
Study date
20 August 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261805
Title
Residual moisture VR Salm Duo
Study date
November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261806
Title
Protocol vials and stoppers
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261807
Title
Chem & Manuf response to s159(1)(a) Notice of 25 July 2023
Study date
October 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248238
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248239
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248240
Title
Vial
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248241
Title
Quality Certificate
Study date
October 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248242
Title
Closure
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248243
Title
Quality Certificate
Study date
November 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248244
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248245
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248246
Title
Frozen storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248247
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248248
Title
Relocation stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248249
Title
In use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248250
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248251
Title
Batch record 200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248252
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248253
Title
Batch record-200401-3c
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248254
Title
Batch record-9475400
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248255
Title
Study no.: 85/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248256
Title
Study no.: 262/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248257
Title
Study no.: 278/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248258
Title
Study no.: 147/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248259
Title
Study no.: 148/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248260
Title
Study no.: 147/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248261
Title
Study no.: 13/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248262
Title
Study no.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248263
Title
Study no.: 485/99
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248264
Title
Study no.: 372/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248265
Title
Study no.: 152/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248266
Title
Study no.: 250/93
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248267
Title
Study no.: 60/96
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248268
Title
M. Voss, 1996 (Study: Lohmann Information 3/96)
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248269
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261808
Title
Study No. 92/92
Study date
19 June 1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261809
Title
SPF-certification relating to Study 85/01
Study date
7 March 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261810
Title
Wird die Wirksamkeit der Immunisierung von K ? ken mit Salmonella-Lebendimpfstoffen durch maternale Anik?rper beeinflusst?
Study date
2002
Auth party contact address
-
Data no
261811
Title
Successful vaccination of layer pullets during the first days of life using a bivalent live vaccine against Salmonella Enteritidis and Salmonella Typhimurium
Study date
September 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261812
Title
Impact of maternal antibodies on the efficacy of immunisation of chicks with live Salmonella vaccines
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278659
Title
Expert Report 4/6/2024
Study date
4 June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270314
Title
Response App 2-12 G-A
Study date
20 March 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270315
Title
Ph. Eur. 2520E
Study date
2013
Auth party contact address
-
Data no
270316
Title
Ph. Eur. 2521E
Study date
2013
Auth party contact address
-
Data no
261813
Title
Safety & Efficacy response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248270
Title
Part 8 Overview AviPro Salmonella Duo
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248271
Title
Expert report on the possible transferability of plasmids between cells of Salmonella VacE and Salmonella VacT during co-cultivation
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248272
Title
PDV/5101-ER/2011-05-04
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248273
Title
Study no.: 37/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248274
Title
Study no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248275
Title
Study no.: 279/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248276
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248277
Title
Study no.: Salmonella 101
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248278
Title
Study no.: LAH2001-1
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248279
Title
Study no.: 188/11
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248280
Title
Study no.: V2011/07
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248281
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248282
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248283
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248284
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248285
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248286
Title
Study: Hannover Veterinary College (Expert report on the safety of a Salmonella vaccine strain for calves and piglets)
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248287
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248288
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac E.
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248289
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248290
Title
Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248291
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248292
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248293
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248294
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella Typhimuriumisolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248295
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248296
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248297
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248298
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248299
Title
Infection model of Salmonella Enteritidis and S. Typhimurium in Pekin ducks (Anas playrhynchos)
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248300
Title
Salmonella infection in a commercial line of ducks; Experimental studies on virulence, intestinal colonization and immune protection
Study date
1999
Auth party contact address
-
Data no
248301
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248302
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248303
Title
Duck-Tec Bruterei GmbH (Administration of AviPro Salmonella Vac E and AviPro Salmonella Vac T to Peking ducks under field conditions
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248304
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248305
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261814
Title
Vaccines for Veterinary Use (Supplement 7.7)
Study date
September 2021
Auth party contact address
-
Data no
261815
Title
Testing Standard 0-0171-TS-BA.01
Study date
20 January 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261816
Title
5.2.6. Evaluation of Safety of Veterinary Vaccines and Immunosera
Study date
04/2024
Auth party contact address
-
Data no
261817
Title
Monograph 2520
Study date
04/2013
Auth party contact address
-
Data no
261818
Title
Monograph 2521
Study date
04/2013
Auth party contact address
-
Data no
248325
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270317
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac T Live Vaccine
Study date
24 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270318
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac E Live Vaccine
Study date
25 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270319
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Duo Live Vaccine
Study date
30 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254979
Title
Common themes among bacteriophage-encoded virulence factors and diversity among the bacteriophages involved.
Study date
2002
Auth party contact address
-
Data no
254980
Title
Vaccination against Salmonella Enteritidis in Dutch commercial layer flocks with a vaccine based on a live Salmonella Gallinarum 9R strain: evaluation of efficacy, safety, and performance of serologic Salmonella tests.
Study date
2001
Auth party contact address
-
Data no
254981
Title
Development of live Salmonella vaccines optimally attenuated for chickens.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254982
Title
Minireview: Antibiotic-supersusceptible mutants of Escherichia coli and Salmonella Typhimurium.
Study date
1993
Auth party contact address
-
Data no
254983
Title
Alterations in outer membrane permeability.
Study date
1984
Auth party contact address
-
Data no
254984
Title
Stable Salmonella live vaccine strains with two or more attenuating mutations and any desired level of attenuation
Study date
1990
Auth party contact address
-
Data no
270320
Title
20240411 Cover letter Salmonella vaccines
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270321
Title
20240411 Response doc-April 2024
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270322
Title
138135-93162 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270323
Title
138146-93168 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270324
Title
138142-93166 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278655
Title
20240923 Response doc-Sept 2024
Study date
23 September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278656
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278657
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278658
Title
13846-93168 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261819
Title
Cover letter for response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248326
Title
Part 1 Application Overview
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248327
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248328
Title
PAA - Salmonella Vaccines Registration in Australia
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248329
Title
Response to: Pre-Application Assistance APVMA Written Assistance Report, questions from pages 6 to 7
Study date
September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248330
Title
Clonal Structure and Variation in Virulence of Salmonella Enteritidis Isolated from Mice, Chickens, and Humans
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248331
Title
The Transformation of Reference Microbiology Methods and Surveillance for Salmonella With the Use of Whole Genome Sequencing in England and Wales
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248332
Title
What WGS Reveals about Salmonella enterica subsp. Enterica in Wildlife in Germany
Study date
2021
Auth party contact address
-
Data no
248333
Title
Advances in typing and identification of foodborne pathogens
Study date
2021
Auth party contact address
-
Data no
248334
Title
Protection Conferred by a Live Salmonella Enteritidis Vaccine Against Fowl Typhoid in Laying Hens
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248335
Title
Oral Vaccination with a Live Salmonella Enteritidis/Typhimurium Bivalent Vaccine in Layers Induces Cross-protection Against Caecal and Internal Organ Colonization by a Salmonella Infantis Strain
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248336
Title
Salmonella enterica Serotype Typhimurium and its Host-Adapted Variants
Study date
2002
Auth party contact address
-
Data no
248337
Title
Genome Variation and Molecular Epidemiology of Salmonella enterica Serovar Typhimurium Pathovariants
Study date
2018
Auth party contact address
-
Data no
248338
Title
Oral Administration of the Salmonella Typhimurium Vaccine Strain NaI2/Rif9/Rtt to Laying Hens at Day of Hatch Reduces Shedding and Caecal Colonization of Salmonella 4, 12:i:-, the Monophasic Variant of Salmonella Typhimurium
Study date
2015
Auth party contact address
-
Data no
248339
Title
Salmonella Infections: Immune and Non-immune Protection with Vaccines
Study date
2007
Auth party contact address
-
Data no
248340
Title
Vaccination and Early Protection Against Non-host-specific Salmonella Serotypes in Poultry: Exploitation of Innate Immunity and Microbial Activity
Study date
2005
Auth party contact address
-
Data no
248341
Title
Review article: Vaccination and early protection against non-host-specific Salmonella serotypes in poultry: exploitation of innate immunity and microbial activity
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248342
Title
Review: The long view: Salmonella - the last forty years
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248343
Title
Salmonella in Domestic Animals (2nd edition
Study date
2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248344
Title
Salmonella infections: immune and non-immune protection with vaccines
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248345
Title
PAA - APVMA Written assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248346
Title
Pre-application Assistance: APVMA Written Assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248347
Title
Part 6 overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248348
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248349
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248350
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248351
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248352
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248353
Title
Report: Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248354
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248355
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248356
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248357
Title
Report on the fourth semester of monitoring Salmonella Typhimurium isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248358
Title
Study no.: H 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248359
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248360
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248361
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248362
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248363
Title
Study no.:525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248364
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
18 August 1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248365
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248366
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248367
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248368
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248369
Title
Study No.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248370
Title
Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248371
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248372
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248373
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248374
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248375
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254985
Title
2023-06-19 Elanco Salmonella Resp to s159 notice
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248306
Title
Part 7 Overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248307
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248308
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248309
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248310
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248311
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248312
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248313
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248314
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248315
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248316
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248317
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248318
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248319
Title
Study: Gantois et al., 2006
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248320
Title
Study: no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248321
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248322
Title
Study no.: 67/01B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248323
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248324
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138142
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application Date
Application Number
138142
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application details
Product name:
AviPro Salmonella Vac E Live Vaccine
Product number:
93166
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction
with approval of an active constituent.
Description of data provided:
Data no
248705
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248706
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248711
Title
Master seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248712
Title
Working seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248714
Title
Batch to batch consistency
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248715
Title
Batch record-5062300
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248716
Title
Batch record-A059400
Study date
09 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248717
Title
Batch record-A059500
Study date
10 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248718
Title
Batch record-G033600
Study date
29 November 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248707
Title
Validation report 0-0063-vr-110-01-01
Study date
21 March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248708
Title
Validation report 0-0060-vr-ba01
Study date
03 Jan 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248709
Title
Validation report 0-0060-vr-91998-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248710
Title
Starting materials of biological origin
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248713
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261822
Title
Batch record Salm VacE
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261823
Title
Residual moisture VR Salm VacE
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248704
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248701
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248702
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248703
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248719
Title
Stability overview and conclusion
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248720
Title
Long term stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248721
Title
Relocation stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248722
Title
In-use stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248723
Title
Stress stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248724
Title
Batch record-6093500
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248725
Title
Batch record-6093700
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248726
Title
Appendix 8-0 Part 8 overview Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248699
Title
Appendix 1-0 Part 1 overview AviPro Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248700
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138146
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application Date
Application Number
138146
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application details
Product name:
AviPro Salmonella Vac T Live Vaccine
Product number:
93168
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of an active constituent (secondary application).
Description of data provided:
Data no
248674
Title
Master seed S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248675
Title
Working see S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248677
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248678
Title
Batch record-6005400
Study date
26 April 2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248679
Title
Batch record-9101100
Study date
9 May 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248680
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248681
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248682
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248676
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261824
Title
Residual moisture VR Salm VacT
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261825
Title
Batch-record Salm VacT
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248667
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248668
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248669
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248670
Title
Validation report 0-0060-vr-92059-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248671
Title
Validation report 0-0060-vr-ba01
Study date
03 January 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248672
Title
Validation report 0-0063-vr-111-01
Study date
29 March 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248673
Title
Starting materials of biological origin
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248664
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248665
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248666
Title
Product development
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248683
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248684
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248685
Title
Intermediate storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248686
Title
In-use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248687
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248688
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248689
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248690
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248691
Title
Batch record-5076600
Study date
1 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248692
Title
Batch record-5076800
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248693
Title
Batch record-5077000
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248694
Title
Part 8 overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248662
Title
Part 1 application overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248663
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138340
Product/Active constituent Name
Application Product Name
MainMan 100 OD Insecticide
Application Date
Application Number
138340
Application Product Name
MainMan 100 OD Insecticide
Application details
Product name:
MainMan 100 OD Insecticide
Product number:
93218
Applicant Name:
ISHIHARA SANGYO KAISHA, LTD
Application purpose and description of use:
Registration of a 100 g/L flonicamid OD oil-based suspension concentrate product for the control of sucking insects in fruit and vegetable crops.
Reference details:
66373 - MAINMAN 500 WG INSECTICIDE
Active constituents:
Active constituent name
65027 - FLONICAMID
Description of data provided:
Data no
249180
Title
Certificate of Analysis
Study date
15/9/2021
Data no
254533
Title
IKI-220 - Vapor Pressure
Study date
30/11/1999
Data no
249191
Title
Validation of analytical HPLC method for the determination of active substance content in an oil dispersion (OD) containing flonicamid.
Study date
9/1/2018
Data no
249192
Title
Development and validation of an Analytical method for the content determination of the impurity Toluene in IKI-220 100 OD
Study date
17/4/2018
Data no
249187
Title
Persistent foaming of IKI-220 100 OD
Study date
29/09/2017
Data no
249190
Title
Certificate of analysis. Determination of the content of active ingredient in IKI-220 100 OD
Study date
29/9/2017
Data no
249181
Title
Information on ingredients
Study date
8/2/2022
Data no
249182
Title
Description of formulation process
Study date
12/02/2022
Data no
249193
Title
Safety Data Sheet IKI-220 100OD
Study date
4/10/2021
Data no
249194
Title
Part 2 Summary
Study date
January 2023
Data no
249183
Title
Accelerated Storage Stability of IKI-220 100 OD in F-HDPE packaging container at 54C for 14 days
Study date
23/3/2020
Data no
249184
Title
Accelerated Storage Stability of IKI-220 100 OD in HDPE/EVOH packaging container at 54C for 14 days
Study date
13/06/2018
Data no
249185
Title
Shelf-Life storage stability of IKI-220 100 OD in HDPE/EVOH Packaging Container over 5 years at 20C (Interim report)
Study date
15/11/2019
Data no
249186
Title
Cold Storage Stability of IKI-220 100 OD in HDPE/EVOH packaging container at 0C for 7 days
Study date
13/06/2018
Data no
249188
Title
Accelerated storage stability for IKI-220 100OD
Study date
09/11/2020
Data no
249189
Title
Accelerated storage stability for IKI-220 100OD
Study date
5/8/2021
Data no
249223
Title
Comparison of flonicamid formulations for control of woolly apple aphid (Eriosoma lanigerum) in apples cv. Jazz - Grove, Tasmania
Study date
5/7/2021
Data no
249224
Title
To compare Flonicamid formulations for control of Woolly Apple Aphid in Apples ??? Pakenham, Vic
Study date
May 2021
Data no
249225
Title
Comparison of MainMan 100 OD with MainMan 500 WG and Movento 240 SC + Hasten for the control of woolly apple aphid (Eriosoma Ianigerum) in apples cv. Red Delicious Stanthorpe, Qld, 2022
Study date
30/07/2022
Data no
249226
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Apples Location: Officer, Victoria Trial Number: 01
Study date
July 2022
Data no
249227
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Apples Location: Officer, Victoria Trial Number: 02
Study date
July 2022
Data no
249228
Title
Comparison of Flonicamid 100 OD with MainMan 500 WG and Movento 240 SC + Hasten for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Royal Gala Stanthorpe, Qld, 2021-22
Study date
14/05/2022
Data no
249229
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Pears Protocol: Pakenham, Victoria
Study date
July 2022
Data no
249230
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Pears Location: Officer, Victoria
Study date
June 2022
Data no
249231
Title
Evaluation of MainMan 100 OD for control of strawberry aphid (Chaetosiphon fragaefolii) in strawberries cv. Amesti Hillwood, Tasmania 2021-22
Study date
09/02/2022
Data no
249232
Title
Evaluation of MainMan 100 OD for control of Aphids in strawberries
Study date
February 2022
Data no
249233
Title
Comparison of MainMan 100 OD with MainMan 500 WG and Transform 240 SC for the control of strawberry aphids (Chaetosiphon fragaefolii) in strawberries cv. Monterey Stanthorpe, Qld, 2021
Study date
01/12/2021
Data no
249234
Title
To compare MainMan formulations for the control of silverleaf whitefly in tomatoes. Bundaberg / Queensland / 2021
Study date
09/03/2022
Data no
249235
Title
Evaluation of MainMan100 OD for control of silverleaf whitefly in tomatoes Field trial conducted in Bowen, Queensland in 2021
Study date
29/11/2021
Data no
249236
Title
To compare MainMan formulations for the control of silverleaf whitefly in protected cropping tomatoes. Bundaberg / Queensland / 2022
Study date
11/08/2022
Data no
249237
Title
To Compare MainMan formulations for control of Silverleaf Whitefly in cucurbits.
Study date
15/11/2021
Data no
249238
Title
Evaluation of MainMan 100 OD and determination of bioequivalence to MainMan 500 WG for the control of silverleaf whitefly in cucurbits. Field trial conducted in Bowen, Queensland in 2021
Study date
28/11/2021
Data no
249240
Title
To compare MainMan formulations for the control of silverleaf whitefly in cucurbits. Bundaberg / Queensland / 2021
Study date
25/02/2022
Data no
249241
Title
To compare MainMan formulations for the control of silverleaf whitefly in cucurbits. Bundaberg / Queensland / 2021
Study date
10/03/2022
Data no
249242
Title
To compare MainMan formulations for the control of aphids in rockmelons. Bundaberg / Queensland / 2021
Study date
17/02/2022
Data no
249243
Title
Evaluation of MainMan 100 OD and MainMan 500 WG for the control of Melon Aphids in rockmelons. Field trial conducted in Bowen, Queensland in 2021
Study date
02/02/2022
Data no
249244
Title
Evaluation of Flonicamid formulations for control of aphids in pumpkins. Field trial conducted in Bowen, Queensland in 2021
Study date
27/11/2021
Data no
249245
Title
To evaluate MainMan 100 OD for control of aphids in eggplant. Bundaberg / Queensland / 2021
Study date
20/02/2022
Data no
249246
Title
Evaluation of MainMan 100 OD for the control of aphids in eggplants Field trial conducted in Bowen, Queensland in 2021
Study date
10/11/2021
Data no
249247
Title
To evaluate Flonicamid 100 OD for control of green peach aphid (Myzus persicae) in capsicum cv. SV6947 Bundaberg / Queensland / 2022
Study date
05/09/2022
Data no
249248
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. Warlock, Gatton, Queensland, 2019
Study date
08/07/2019
Data no
249249
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. SV6947 Bundaberg, Queensland, 2019
Study date
04/09/2019
Data no
249250
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. Warlock, Bowen, Queensland, 2019
Study date
11/12/2019
Data no
249251
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) and for crop safety in capsicums cv. Remy Virginia, South Australia, 2019
Study date
02/03/2020
Data no
249252
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicums cv. Warlock Bowen, Queensland, 2019
Study date
23/03/2020
Data no
249253
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicums cv. Warlock Gatton, Queensland, 2020
Study date
28/04/2020
Data no
249254
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. Plato, Gatton, Queensland, 2016
Study date
16/06/2017
Data no
249255
Title
To compare MainMan formulations for control of aphids in potatoes. Bundaberg / Queensland / 2021
Study date
03/02/2022
Data no
249256
Title
Flonicamid formulations for control of aphids in potatoes. Mount Barker (Pot trial) & Dog Lake Road (Crop safety trial), South Australia, 2022
Study date
22/6/2022
Data no
249257
Title
To compare flonicamid formulations for control of aphids in potatoes. Bundaberg / Queensland / 2022
Study date
02/08/2022
Data no
249260
Title
Part 8 Summary
Study date
January 2022
Data no
249239
Title
Evaluation of MainMan 100 OD and determination of bioequivalence to MainMan 500 WG for the control of silverleaf whitefly in rockmelons. Field trial conducted in Bowen, Queensland in 2021
Study date
02/02/2022
Data no
254534
Title
Acute toxicity of IK-220 technical to first-instar larvae of Chironomus riparius
Study date
21/02/2002
Data no
254535
Title
Effects of IKI-220 technical on the development of sediment-dwelling larvae of Chironomus riparius
Study date
23/10/2002
Data no
254536
Title
IKI-220 technical: a 7-day static-renewal toxicity test with duckweed (Lemna gibba G3)
Study date
24/06/2002
Data no
254537
Title
Assessment of side effects of IKI-220 500WG (Teppeki) on the Honeybee (Apis mellifera L.) in a Semi-Field study in The Netherlands after one application on Phacelia tanacetifolia in 2019
Study date
30/07/2020
Data no
254538
Title
Assessment of side effects of IKI-220 500WG (Teppeki) following the OEPP/EPPO Guideline No. 170 on the Honeybee (Apis mellifera L.) in a Semi-Field study in The Netherlands after one application on Phacelia tanacetifolia in 2019
Study date
04/08/2020
Data no
259465
Title
IKI-220: Acute survival of honey bee larvae, Apis mellifera L., during an In Vitro exposure
Study date
13/10/2016
Data no
259466
Title
IKI-220: 22-day survival of honey bee larvae, Apis mellifera L., during an In Vitro exposure
Study date
21/12/2016
Data no
259467
Title
IKI-220: 10-day oral toxicity test with the honey bee (Apis mellifera)
Study date
28/12/2017
Data no
259468
Title
IKI-220 TGAI: Acute contact toxicity test with the honey bee (Apis mellifera)
Study date
19/01/2015
Data no
259469
Title
IKI-220: 13-day oral toxicity test with the adult honey bee (Apis mellifera)
Study date
21/02/2019
Data no
259470
Title
IKI-220 TGAI: Acute oral toxicity test with the honey bee (Apis mellifera)
Study date
09/12/2014
Data no
249219
Title
IKI-220 50%WG: Collembolan Reproduction Test in Soil
Study date
17/9/2020
Data no
249218
Title
IKI-220 50%WG: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil
Study date
29/9/2020
Data no
249213
Title
Side effects of FT1785 500 WG on soil microorganisms: Nitrogen and Carbon cycles
Study date
12/12/2002
Data no
249214
Title
Side effects of Flonicamid Tecnico on soil microorganisms: Nitrogen transformation test
Study date
28/03/2033
Data no
249215
Title
Side effects of Flonicamid Tecnico on soil microorganisms: Carbon transformation test
Study date
07/02/2003
Data no
249216
Title
Effects of IKI-220 50 % WG on the Activity of the Soil Microflora in the Laboratory
Study date
13/12/2002
Data no
249222
Title
Part 7 Summary
Study date
January 2023
Data no
249220
Title
Acute toxicity of F1785 500 WG to earthworm Eisenia fetida
Study date
19/12/2002
Data no
249221
Title
IKI-220 50%WG???Effect on Reproduction in the Earthworm Eisenia fetida
Study date
13/1/2021
Data no
249259
Title
Mainman 500 WG Insecticide label 66373/137302
Study date
12/2022
Auth party contact address
-
Data no
259464
Title
Response to Section 159(1)(a) Notice for application 93218/138340
Study date
September 2023
Data no
249217
Title
Early release of reviewer assessment
Study date
18/08/2014
Data no
249258
Title
Early release of reviewer assessment
Study date
10/10/2013
Data no
249210
Title
Magnitude of the residues of flonicamid in potato (RAC tubers) following two applications of IBE 4084 (IKI-220 100OD) in eight trials (8 RDCS), Northern and Southern Europe (Germany, France, The United Kingdom, The Netherlands, Spain and Italy) ??? 2017
Study date
06/08/2018
Data no
249205
Title
Flonicamid: Magnitude of the residue on tomato (field and greenhouse)
Study date
17/10/2012
Data no
249206
Title
Determination of residues of flonicamid in fruiting vegetables following three applications of Mainman 500 WG
Study date
25/03/2020
Data no
249207
Title
Magnitude of residues of IKI-220 on fruiting vegetables ??? USA in 2001
Study date
14/01/2020
Data no
249208
Title
Flonicamid: magnitude of the residue on strawberry
Study date
14/10/2010
Data no
259458
Title
Magnitude of the residues of flonicamid and its metabolites (TFNA and TFNG) in wheat (RAC Whole plant w/o roots, ears, stem, hay, grain and straw) following one or two foliar applications of IBE 4084 (IKI-220 100 OD) or IBE 3894 (IKI-220 500 WG), Northern and Southern Europe ? 2018.
Study date
11/01/2019
Data no
259459
Title
Magnitude of the residues of flonicamid and its metabolites (TFNA and TFNG) in winter wheat (RAC whole plant, ear, stem, grain, straw) following two foliar applications of IBE 4084 (IKI-220 100OD) and IBE 3894 (IKI-220 50% WG) in four trials (4 DCS), Northern and Southern Europe (Germany, The United Kingdom, Italy and Southern France) ? 2017.
Study date
30/03/2018
Data no
259460
Title
Magnitude of the residues of flonicamid and its metabolites TFNG and TFNA in winter oilseed rape (RAC seeds), following one application of IBE 3894 or IBE 4084 in four trials (4 HS), Northern and Southern Europe (Northern and Southern France and Germany) ? 2017, 2018
Study date
03/12/2018
Data no
259461
Title
Magnitude of the residues of flonicamid and its metabolites (TFNA and TFNG) in winter wheat (RAC forage, hay, grain, straw and processed fractions) following two foliar applications of IBE 4084 (IKI-220 100OD) and IBE 3894 (IKI-220 50% WG) in four trials (4 SDCS), Northern and Southern Europe (France, the Netherlands and Italy) ? 2017.
Study date
07/02/2019
Data no
249209
Title
Storage stability of IKI-220 (F1785) and its major plant metabolites in/on laboratory-fortified matrices from five representative crop groups: oilseed, non-oily grain, leafy vegetable, root and tuber vegetable crop, and fruit or fruiting vegetable, and their processed parts
Study date
4/12/2002
Data no
249211
Title
Residue Database Form for Mainman 100 OD Insecticide
Study date
December 2022
Data no
249212
Title
Part 5 Summary
Study date
January 2023
Data no
259462
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid
Study date
2010
Auth party contact address
-
Data no
259463
Title
Draft registration report Part B Section 7 Metabolism and Residues
Study date
30/11/2019
Data no
249196
Title
Acute Dermal Toxicity (Limit Test) in the Rat with IKI-220 100OD
Study date
31/8/2017
Data no
249200
Title
Acute Eye Irritation/Corrosion in the Rabbit with IKI-220 100OD
Study date
12/1/2018
Data no
249197
Title
IKI-220 100OD: Acute Inhalation Toxicity in Rats
Study date
11/1/2018
Data no
249195
Title
Acute Oral Toxicity (Acute Toxic Class Method) in the Rat with IKI-220 100OD
Study date
18/1/2018
Data no
249198
Title
In vitro Skin Irritation: Human Skin Model Test (Epiderm???) with IKI-220 100OD
Study date
09/1/2018
Data no
249201
Title
Test for Sensitisation (Local Lymph Node Assay ??? LLNA) with IKI-220 100OD
Study date
16/1/2018
Data no
249202
Title
Advice Summary 66373/53527
Study date
14/08/2007
Data no
249203
Title
Toxicology data base form
Study date
July 2021
Data no
249204
Title
Part 3 Summary
Study date
January 2023
Data no
249199
Title
In-vitro human skin penetration of 14C-IKI-220 in IKI-220 OD Test Item
Study date
28/8/2019
Date
Application Date
Application No
Application Number
138164
Product/Active constituent Name
Application Product Name
Fulltec
Application Date
Application Number
138164
Application Product Name
Fulltec
Application details
Product name:
Fulltec
Product number:
93179
Applicant Name:
SPRAYTEC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 216.1g/L Phosphoric Acid Soluble Liquid product to ameliorate water hardness and pH, improve spray coverage and target penetration, and minimise inadvertent losses due to evaporation, drift and foaming.
Reference details:
62541 - WETTER 1000 SURFACTANT
47999 - HASTEN SPRAY ADJUVANT
41255 - UPTAKE SPRAYING OIL
46871 - Nufarm BS1000 Adjuvant
41510 - Nufarm Liase Adjuvant
54116 - AGRAL SPRAY ADJUVANT
Description of data provided:
Data no
248490
Title
Quantification Study 5 Batch
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248482
Title
Part 2 A Chemistry and Manufacture
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248483
Title
Part 2 B Chemistry and Manufacture
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276598
Title
Investigation into the Efficacy of Spraytec's Fulltec and Fulltec Max Chelating Agent and their pH Reducing Properties.
Study date
June, 2024
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248485
Title
Product Technical Sheet
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248486
Title
Product Technical Sheet
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248487
Title
Quality Report
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248488
Title
Quality Report
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248489
Title
Study of Physico-Chemical Properties
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248484
Title
Physico - Chemical Properties
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276595
Title
Efficacy of Spraytec Adjuvants, Applied Post-Emergent with Various Herbicides, for Amsinckia (Amsinckia sp. and Deadnettle (Lamium amplexicaule) control in Wheat cv. Scepter.
Study date
Dec, 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276596
Title
Agricultural Trials with an Agronomic Focus, Spraytec Canola Herbicide Trial Winter 2023
Study date
September, 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276597
Title
Spraytec Additives: Post-Emergent ARG Contral in Canola, Gairdner WA.
Study date
July, 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276599
Title
Response to APVMA S159 Notice
Study date
01/06/2024
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248518
Title
Knockdown Trial Greenmount, QLD, 2021
Study date
September, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248519
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248520
Title
Spraytec Adjuvant/Knockdown
Study date
May, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248521
Title
Spraytec Adjuvants and Trace Elements
Study date
May, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248491
Title
Part 8 - Efficacy and Crop Safety
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248492
Title
Can the adjuvant FullTec or FullTec Max boost efficacy of glyphosate, 2,4-D and Triclopyr to control summer weeds in Australia
Study date
March, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248493
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted annual ryegrass (Lolium rigidum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248494
Title
Evaluation of Fulltec and Fulltec Max when combined with Nitro 240 SL for the control of potted annual ryegrass (Lolium rigidum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248495
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted wild radish (Raphanus raphanistrum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248496
Title
Evaluation of Fulltec and Fulltec Max when combined with Velocity 247 EC for the control of potted wild radish (Raphanus raphanistrum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248497
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248498
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248499
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
May, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248500
Title
Efficacy of Top Zinc Max applied as a seed treatment or a foliar application mixed with Velocity applied to Yitpi wheat at BBCH21 or mixed with a fungicide and applied at BBCH30 Northam, WA, 2020
Study date
April, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248501
Title
Summer Weed Control Griffith, NSW, 2020
Study date
April, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248502
Title
Summer Weed Control Maaoupe, SA, 2021
Study date
April, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248503
Title
A comparison of Fulltec and Fulltec Max on efficacy of herbicide mixes on paddy melon (Cucuis myriocarpus) Northam, WA, 2020
Study date
May, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248504
Title
Spraytec Knockdown Trial Narrabri, NSW, 2021
Study date
July, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248505
Title
Yield response to herbicide and fungicide treatments using different adjuvants in barley, Quairading, Western Australia 2020
Study date
Mar, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248506
Title
The Efficacy of Spraytec Adjuvants on a Summer Spray, Cascade 2020/2021
Study date
Feb, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248507
Title
The efficacy of FullTec and FullTec Max Adjuvants in a Summer Knock-Down MYRUP 2021
Study date
March, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248508
Title
ntrol of summer weeds (Afghan melon) using Fulltec and Fulltec Max additives to herbicide mixtures, Meckering, Western Australia 2020
Study date
September, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248509
Title
Adjuvant mixtures for the control of prickly paddy melon (Cucumis myriocarpus) and caltrop (Tribulus terrestris orientalis) in a summer fallow, York, Western Australia 2020
Study date
March, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248510
Title
Efficacy of Fulltec and Fulltec Max for summer weed control in fallow Nelshaby, South Australia, 2020
Study date
June, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248511
Title
djuvant Packages on Herbicide and Fungicide Applications in Wheat Coomalbidgup, Western Australia 2021
Study date
Dec, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248512
Title
Alternative adjuvants/mix partners used in combination with herbicides and fungicides in wheat, York, Western Australia 2021
Study date
Feb, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248513
Title
Alternative adjuvants/mix partners used in combination with herbicides and fungicides in canola, York, Western Australia 2021
Study date
Feb, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248522
Title
Wind Tunnel Trial
Study date
Feb, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248514
Title
Evaluation of Fulltec in combination with Rival 750 WG for crop safety to potted barley cv. Baudin. Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248515
Title
Evaluation of Fulltec in combination with Rival 750 WG for crop safety to potted wheat cv. Zen. Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248516
Title
Evaluation of Fulltec in combination with Prosaro 420 SC for crop safety to potted wheat cv. Zen Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248517
Title
Evaluation of Fulltec in combination with Prosaro 420 SC for crop safety to potted barley cv. Baudin Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
264504
Title
Response to s159 Notice
Study date
Nov 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248481
Title
Covering Letter
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Date
Application Date
Application No
Application Number
138168
Product/Active constituent Name
Application Product Name
Fulltec Max
Application Date
Application Number
138168
Application Product Name
Fulltec Max
Application details
Product name:
Fulltec Max
Product number:
93181
Applicant Name:
SPRAYTEC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 123.3g/L phosphoric acid soluble liquid product to ameliorate water hardness and pH, improve spray coverage and target penetration, and minimise inadvertent losses due to evaporation, drift and foaming.
Reference details:
62541 - WETTER 1000 SURFACTANT
47999 - HASTEN SPRAY ADJUVANT
41255 - UPTAKE SPRAYING OIL
46871 - Nufarm BS1000 Adjuvant
41510 - Nufarm Liase Adjuvant
54116 - AGRAL SPRAY ADJUVANT
Description of data provided:
Data no
248526
Title
Fulltec Max 00610-QNT
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248523
Title
Part 2 - Chemistry and Manufacturing
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248524
Title
Study of Physico-Chemical Properties
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248525
Title
Fulltec Max 00610-EQ
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Date
Application Date
Application No
Application Number
138092
Product/Active constituent Name
Application Product Name
Uvasys Vivo Sulphur Dioxide Generator
Application Date
Application Number
138092
Application Product Name
Uvasys Vivo Sulphur Dioxide Generator
Application details
Product name:
Uvasys Vivo Sulphur Dioxide Generator
Product number:
93143
Applicant Name:
Tessara Pty Ltd
Application purpose and description of use:
Registration of a 150 g/kg meta bisulphate slow release sulphur dioxide generator product for table grape preservation during cold storage.
Reference details:
52162 - UVASYS SULPHUR DIOXIDE GENERATORS
Description of data provided:
Data no
247594
Title
Certificate of Analysis sodium metabisulphite.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268473
Title
Iodine titration and NaOH emission testing method validation. Doc No. T05.06.0323
Study date
September 2023
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247592
Title
Product information sheets for adhesive components.
Study date
2008
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247593
Title
Product data sheets for polypropylene constituents. Various dates and suppliers
Study date
2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247596
Title
Uvasys Vivo Sulphur Dioxide Generator Chemistry Dossier ID DC10-45410985.
Study date
December 2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268472
Title
Uvasys Vivo Sulphur Dioxide Generator Chemistry Dossier ID DC10-45410985. December 2022, Amended 3 Feb and 11 March 2024
Study date
11 March 2024
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
267528
Title
Accelerated Storage Stability Report. Amended Report date 2 February 2024.
Study date
2 Feb 2024
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247595
Title
Accelerated Storage Stability Report
Study date
2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268474
Title
.Accelerated Storage Stability Report. Amended Report date 2 February 2024
Study date
2 February 2024
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268475
Title
Physico-chemical Properties for UVASYS sheets over 3 years stored between 15-30?C.
Study date
August 2018.
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247598
Title
Uvasys Vivo Trial Report 2020. Tessara Research and Development.
Study date
July 2020
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247599
Title
Uvasys Vivo Second In-house Verification Trial Report???
Study date
March 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247600
Title
Uvasys Vivo Independent Verification Trial Report
Study date
July 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247601
Title
Uvasys Vivo in table grapes: Storage trial.
Study date
June 2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247602
Title
Frigga data report for Grower trial A Colignan Victoria.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247603
Title
Sulphur Dioxide Residues in Grapes for Grower trial A Colignan
Study date
2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247604
Title
Frigga data report for Grower trial B Mundubbera Queensland
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256919
Title
Uvasys Vivo 93143_138092 Response to June 27 2023 s159 Notice
Study date
27 July 2023
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256920
Title
Uvasys Efficacy dossier DC10-454109 - edited to include s159 response information
Study date
July 2023
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256921
Title
Australian Trial 2 Grower Trial A Colignan
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256922
Title
Australian Trial 3 Grower Trial B Mundubbera 2020
Study date
2020
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256923
Title
Grower Trial A Colignan Victoria. Raw data for Sweet Sapphire grapes.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256924
Title
Grower Trial A Colignan Victoria.Raw data for Sweet Sapphire grapes.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256925
Title
Grower Trial A Colignan Victoria. Raw data for Timco grapes.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256926
Title
Raw data Spreadsheet ?- Grower Trial B Mundubbera Queensland.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256927
Title
Uvasys Vivo Second In-house Verification March 2021 taste and stem quality raw data spreadsheet.
Study date
March 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256928
Title
Uvasys Vivo Second In-house Verification July 2021 taste and stem quality raw data spreadsheet.
Study date
July 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247605
Title
Uvasys Vivo Crop Safety and Efficacy dossier DC10-45410985
Study date
16 Dec 2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247597
Title
Uvasys Sulphur Dioxide Generators label (APVMA No. 52162_117777.
Study date
1 Oct 2010
Auth party contact address
-
Date
Application Date
Application No
Application Number
138157
Product/Active constituent Name
Application Product Name
VERSYS INSECTICIDE
Application Date
Application Number
138157
Application Product Name
VERSYS INSECTICIDE
Application details
Product name:
VERSYS INSECTICIDE
Product number:
82738
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Variation of product registration and label approval to add additional uses in additional crops
Active constituents:
Active constituent name
82739 - AFIDOPYROPEN
Description of data provided:
Data no
248451
Title
The efficacy of EXP5845955I-CI and BAS 44000I against long tailed mealybug (Pseudococcus longispinus) in wine grapes
Study date
2016
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248452
Title
The efficacy of BAS44101l and BAS 44000I against mealybug (Pseudococcus Sp.) in wine grapes
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248453
Title
The efficacy of BAS44101l and BAS 44000I against mealybug (Pseudococcus Sp.) in wine grapes
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248454
Title
The efficacy of BAS 550 01I and BAS 440 00I against mealybug (Pseudococcus Sp.) in wine grapes
Study date
2018
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248455
Title
The efficacy of BAS 550 01I and BAS 440 00I against mealybug (Pseudococcus Sp.) in wine grapes
Study date
2018
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248456
Title
Evaluation of BAS55001 insecticide for control of Mealybug in grapes
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248457
Title
Efficacy of BAS 55001I for mealybug control in grapes, Cowaramup, Western Australia 2022
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248458
Title
Evaluation of BAS55001 insecticide for control of Mealybug in grapes
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248459
Title
Efficacy of BAS 55001I for mealybug control in grapes, Belhus, Western Australia 2022
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248460
Title
Efficacy of BAS 55001I for mealybug control in grapes,
Belhus, Western Australia
2022
Belhus, Western Australia
2022
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248461
Title
To Investigate the efficacy and crop safety of BAS 440 formulations for mealybug control in grapes. Hawkes Bay, New Zealand, 2013/2014
Study date
2011
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248462
Title
TO EVALUATE THE EFFICACY AND CROP SAFETY OF BAS 440 UVI ME AGAINST MEALYBUG IN GRAPES HAWKE?S BAY, NEW ZEALAND, 2014/2015
Study date
2014
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248463
Title
Further evaluation of BAS 440 UBI SC (#1752), BAS 440 UCI EC (#1735) and BAS 440 UVI ME (#1766) ME for their efficacy against Mealybug - (Pseudococcus spp.) in Grapes.
Study date
2013
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248464
Title
An evaluation of BAS 440 UVI (1766-17) for its efficacy against Mealybug - (Pseudococcus spp.) in Grapes
Study date
2014
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248465
Title
An evaluation of BAS 440 00I (FD-140915-0038) for its efficacy against Mealybug - (Pseudococcus spp.) in Grapes
Study date
2015
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248466
Title
An evaluation of VERSYS (BAS44000I) and BAS 55001I (BAS55001) for their efficacy against Mealybug - (Pseudococcus spp.) in Grapes.
Study date
2018
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248467
Title
An evaluation of VERSYS (afidopyropen), and BAS 55001I (BAS55001) for their efficacy against Mealybug - (Pseudococcus spp.) in Grapes.
Study date
2020
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248468
Title
Evaluation of BAS 44000I 100 DC +/- Agral 600 SL, BAS 44101I 75 DC +/- Agral 600 SL, BAS 550UGI 120 SL and
Movento 240 SC + Hasten 704 L for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Sundowner Stanthorpe, Qld, 2017-18
Movento 240 SC + Hasten 704 L for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Sundowner Stanthorpe, Qld, 2017-18
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248469
Title
EVALUATION THE EFFICACY OF BAS 550UGI AND BAS 44000I INSECTICIDE FOR THE CONTROL OF LONG TAILED MEALYBUGS IN PEAR, ONE FIELD TRIAL, SHEPPARTON EAST, VICTORIA, AUSTRALIA, 2018
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248470
Title
EVALUATION THE EFFICACY OF BAS 550UGI AND BAS 44000I INSECTICIDE FOR THE CONTROL OF LONG TAILED MEALYBUGS IN PEAR, ONE FIELD TRIAL, SHEPPARTON EAST, VICTORIA, AUSTRALIA, 2018
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248471
Title
Part 8 Dossier Summary
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248472
Title
Comparison of BAS 55001I 120 SL +/- Hasten 704 L, BAS 44000I 100 DC +/- Hasten & Sivanto 200 SL with Movento 240 SC + Hasten and Samurai 500 WG for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Royal Gala Stanthorpe, Qld, 2018-19
Study date
2018
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248473
Title
Comparison of BAS 55001I 120 SL +/- Hasten 704 L, BAS 44000I 100 DC +/- Hasten & Sivanto 200 SL with Movento 240 SC + Hasten and Samurai 500 WG for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Sundowner Stanthorpe, Qld, 2018-19
Study date
2018
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248474
Title
Comparison of BAS 55001I 120 SL +/- Hasten 704 EC and BAS 44000I 100 DC with Movento 240 SC + Hasten,
Samurai 50 WG and Sivanto 480 FS for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Royal Gala Stanthorpe, Qld, 2021-22
Samurai 50 WG and Sivanto 480 FS for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Royal Gala Stanthorpe, Qld, 2021-22
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248475
Title
Comparison of BAS 55001I 120 SL +/- Hasten 704 EC and BAS 44000I 100 DC with Movento 240 SC + Hasten, Samurai 50 WG and Sivanto 480 FS for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Royal Gala Stanthorpe, Qld, 2021-22
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248476
Title
Evaluation of BAS55001 insecticide for control of Mealybug in apples
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248434
Title
EVALUATION OF THE EFFICACY OF VERSYS (AFIDOPYROPEN) FOR THE CONTROL OF CARROT APHID IN CARROTS
Study date
2017
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248435
Title
EVALUATION OF THE EFFICACY OF VERSYS (AFIDOPYROPEN) FOR THE CONTROL OF CARROT APHID IN CARROTS
Study date
2021
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248436
Title
Evaluation of Versys 100 DC for the control of banana aphids (Pentalonia nigronerversa) in dwarf Lady Finger
bananas
bananas
Study date
2017
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248437
Title
Evaluation of Versys 100 DC for the control of banana aphids (Pentalonia nigronerversa) in Cavendish bananas
Study date
2021
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248438
Title
Evaluation of Versys 100 DC for the control of banana aphids (Pentalonia nigronerversa) in Cavendish bananas
cv. Williams
cv. Williams
Study date
2020
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248439
Title
Evaluation of Versys 100 DC for the control of Banana Aphid (Pentalonia nigronerversa) in Bananas cv.
Cavendish
Cavendish
Study date
2020
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248440
Title
Evaluation of Versys 100 DC for the control of banana aphids (Pentalonia nigronerversa) in dwarf Lady Finger
bananas
bananas
Study date
2021
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248441
Title
Evaluation of Versys 100 DC for the control of banana aphids (Pentalonia nigronerversa) in Cavendish bananas
?Williams?
?Williams?
Study date
2021
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
270245
Title
NAS-WA-23-LMB-NACT-I05
Study date
2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270246
Title
NAS-WA-23-MBPRED-I04
Study date
2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270247
Title
Evaluation of BAS55001 on long tailed mealybug in grapes (001)
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270248
Title
Evaluation of BAS55001 on long tailed mealybug in grapes (002)
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270249
Title
Evaluation of BAS 550I 120 SL for the control of long-tailed mealybug (Pseudococcus longispinus) in wine grapes var. Cabernet Sauvignon Cowaramup, Western Australia, 2023
Study date
2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270250
Title
Evaluation of BAS 550 01I 120 SL for the control of long-tailed mealybug (Pseudococcus longispinus) in table grapes cv. Dawn Seedless. Swan Valley, Western Australia, 2023-24
Study date
2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270251
Title
DEV-I-2021-AU-206-A-01.0-AU-ASV-001 Mealybug SUPPLEMENTAL
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270252
Title
Efficacy of BAS 55001I for Longtailed mealybug control in grapes, Cowaramup, Western Australia, 2022 (updated)
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270253
Title
Efficacy of BAS 55001I for Longtailed mealybug control in grapes, Belhus, Western Australia, 2022 (updated)
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270254
Title
Versys Insecticide Supplementary Data Summary - EFFICACY AND CROP SAFETY
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248477
Title
CONSENT TO RELEASE REPORT(S) CONTAINING PROTECTED DATA TO BASF AUSTRALIA LTD
Study date
2022
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248444
Title
Determination of the residues of afidopyropen in carrot
Study date
2019
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248445
Title
Determination of the residues of afidopyropen in bulb vegetables - shallot, spring onion and leek
Study date
2020
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248446
Title
Determination of the residues of afidopyropen in green beans, snow peas and sugar snap peas
Study date
2022
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248447
Title
Determination of residues of afidopyropen in passionfruit following four applications of Versys insecticide
Study date
2020
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248448
Title
Determination of residues of afidopyropen in lychees following four applications of Versys Insecticide
Study date
2022
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248449
Title
Determination of residues of afidopyropen in berries following four applications of Versys Insecticide
Study date
2020
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248450
Title
Determination of residues of afidopyropen in unbagged and bagged bananas following four applications of Versys Insecticide
Study date
2022
Auth party contact address
Level 7, 141 Walker Street, North Sydney, NSW, 2060, Australia
Data no
248431
Title
A regulatory study to determine the residue profile of Afidopyropen (BAS 440 00 I) when applied to grapes in New Zealand during the summer.
Study date
2018
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248432
Title
A regulatory study to determine the residue profile of Afidopyropen (BAS 440 00 I) when applied to grapes.
Study date
2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248433
Title
Determination of BAS 440 00 I in wine and table grapes
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
270255
Title
Fermentation and Sensory evaluation of wines relating to the application of VERSYS insecticide to winegrapes
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248442
Title
Fermentation and Sensory evaluation of wines relating to the application of VERSYS insecticide to winegrapes
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
248443
Title
Part 5 Dossier Summary
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
138155
Product/Active constituent Name
Application Product Name
Bacillus amyloliquefaciens strain FZB24
Application Date
Application Number
138155
Application Product Name
Bacillus amyloliquefaciens strain FZB24
Application details
Product name:
Bacillus amyloliquefaciens strain FZB24
Product number:
93174
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 130 g/kg Bacillus amyloliquefaciens strain FZB24 wettable powder product for disease control in grapes, in conjunction with approval of Bacillus amyloliquefaciens strain FZB24.
Date
Application Date
Application No
Application Number
137985
Product/Active constituent Name
Application Product Name
VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT
Application Date
Application Number
137985
Application Product Name
VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT
Application details
Product name:
VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT
Product number:
48185
Applicant Name:
ALLTECH LIENERT AUSTRALIA PTY LTD
Application purpose and description of use:
The product Virkon S is registered with the APVMA with the following statement of claims: A disinfectant cleanser for use in cleaning and disinfecting industrial, veterinary, animal and agricultural equipment and facilities. This application is seeking the addition of a new use pattern to an already approved usage:
Reference details:
48185 - VIRKON S THE BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT
68503 - VIRKON AQUATIC BROAD SPECTRUM VIRUCIDAL BACTERICIDAL FUNGICIDAL DISINFECTANT
Active constituents:
Active constituent name
49282 - POTASSIUM PEROXOMONOSULPHATE TRIPLE SALT
Description of data provided:
Data no
247372
Title
Performance and endocrine responses of group housed weaner pigs
exposed to the air quality of a commercial environment
exposed to the air quality of a commercial environment
Study date
01/05/2005
Auth party contact address
-
Data no
247374
Title
Evaluation of the effect on Broiler Chickens sprayed and fogged with Virkon S
Study date
04/07/2005
Auth party contact address
-
Data no
274297
Title
Effects of disinfectant fogging procedure on dust, ammonia concentration, aerobic bacteria and fungal spores in a farrowing-weaning room
Study date
2014
Auth party contact address
-
Data no
274298
Title
Assessment of the effectiveness of Virkon S fogging application on bacterial surface - and air contamination in a commercial broiler production farm in the presence of animals
Study date
08/08/2016
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247375
Title
1pct solution data sheet 02.02.2018
Study date
02/02/2018
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247370
Title
Guidance on the Biocidal Products Regulation
Study date
01/12/2017
Auth party contact address
-
Data no
247371
Title
Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides
Study date
15/01/2015
Auth party contact address
-
Data no
247373
Title
ECHA Substance information
Study date
08/09/2020
Auth party contact address
-
Data no
247376
Title
Summary of the Investigation to Test the Effect of Prolonged Spraying of Livestock with Virkon? S
Study date
1987
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
274299
Title
Evaluation of the effect on broiler chickens sprayed and fogged with Virkon S.
Study date
09/02/1996
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
274300
Title
Investigation to test the effect of prolonged spraying of livestock with Virkon S
Study date
03/08/1987
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247369
Title
Virkon S: Exposure Assessment
Study date
01/07/2018
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
274301
Title
Response to s159
Study date
06/2024
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247363
Title
Application to add claim and use pattern to registered product Virkon S
Study date
20/10/2022
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247377
Title
Virkon S SIPO Global summary of approvals
Study date
14/02/2020
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
253799
Title
Microbial air quality and bacterial surface contamination in ambulances during patient services
Study date
2015
Auth party contact address
-
Data no
253800
Title
Factors Affecting the Efficacy of Disinfection and Sterilization
Study date
2008
Auth party contact address
-
Data no
253801
Title
Air quality in pig housing facilities
Study date
1997
Auth party contact address
-
Data no
253802
Title
The effect of Virkon S disinfection on the reduction of losses caused by PFTS
Study date
2014
Auth party contact address
-
Data no
253803
Title
Risks caused by bio-aerosols in poultry houses
Study date
2007
Auth party contact address
-
Data no
247364
Title
Pre-application Assistance ? APVMA Written Assistance
Study date
25/05/2021
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247365
Title
RESIDUES AND TRADE EVALUATION REPORT
Study date
01/05/2021
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247366
Title
Toxic Residue Data
Study date
01/05/2017
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247367
Title
Component Degradation Profiles
Study date
01/05/2017
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Data no
247368
Title
Virkon S: Exposure Assessment Summary
Study date
01/11/2019
Auth party contact address
8 Roseworthy Rd ROSEWORTHY Australia
Date
Application Date
Application No
Application Number
137982
Product/Active constituent Name
Application Product Name
Farmalinx Volt 120 SC Insecticide
Application Date
Application Number
137982
Application Product Name
Farmalinx Volt 120 SC Insecticide
Application details
Product name:
Farmalinx Volt 120 SC Insecticide
Product number:
93107
Applicant Name:
FARMALINX PTY LTD
Application purpose and description of use:
Registration of a 120 g/L spinosad suspension concentrate product for control of pests in turf.
Reference details:
89916 - Surefire Preserve 120 SC Insecticide
88118 - Entrust Organic Qalcova Active Insecticide
59914 - Conserve Qalcova active Grain Protector
Active constituents:
Active constituent name
89208 - SPINOSAD
Description of data provided:
Data no
247221
Title
Method Validation for the determination of spinosad in a Suspension concentrate (SC)
Study date
3 July 2020
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247223
Title
Certificate of Analysis - active
Study date
18 November 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247224
Title
Raw material SDS
Study date
4 December 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
262504
Title
Analysis of physical property
Study date
1 September 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
262505
Title
Response to s159
Study date
1 September 2023
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247220
Title
The formulation development of Farmalinx Volt 120 SC Insecticide
Study date
July 2020
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247222
Title
Certificate of Analysis - Stability
Study date
3 July 2020
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247230
Title
Efficacy and Crop Safety
Study date
November 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247232
Title
US label
Study date
28 November 2014
Auth party contact address
-
Data no
247233
Title
Evaluation of Spinosad for the Control of a pest in turf - ISP503
Study date
26 August 2021
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247234
Title
Control of a pest in turf - ISP 548
Study date
17 September 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247231
Title
Proposed Draft Label
Study date
23 November 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247228
Title
Environmental Safety
Study date
4 December 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247229
Title
Proposed label
Study date
4 December 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247225
Title
Occupational Health and Safety
Study date
4 December 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247226
Title
Proposed label
Study date
4 December 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
247227
Title
Raw material SDS
Study date
4 December 2022
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Date
Application Date
Application No
Application Number
137589
Product/Active constituent Name
Application Product Name
Metarylpicoxamid
Application Date
Application Number
137589
Application Product Name
Metarylpicoxamid
Application details
Product name:
Metarylpicoxamid
Product number:
93002
Applicant Name:
CORTEVA AGRISCIENCE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of GF-4898 Fungicide, an emulsifiable concentrate for the control of Asian soybean rust in soybean, in conjunction with approval of metarylpicoxamid
Description of data provided:
Data no
247570
Title
Analytical Method and Validation for the Determination of Assay in XDE-747 Technical Grade Material (AM-211631 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247571
Title
Analytical Method and Validation for the Determination of Assay and Impurities in XDE-747 Technical Grade Material (AM-211625 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247572
Title
Analytical Method and Validation for the Determination of Impurities in XDE-747 Technical Grade Material (AM-220133 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247573
Title
Analytical Method and Validation for the Determination of an Impurity in XDE-747 Technical Grade Material by Gas Chromatography (AM-220153 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247574
Title
Analytical Method and Validation for the Determination of an Impurity in XDE-747 Technical Grade Material by Gas Chromatography (AM-220311 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247567
Title
Analysis of Product Samples for Active Ingredient and Impurities in Metarylpicoxamid Technical Grade Active Ingredient (220333 study)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247568
Title
Analysis of Product Samples for Active Ingredient and Impurities in Metarylpicoxamid Technical Grade Active Ingredient (220334 study)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247569
Title
Analysis of Product Samples for Active Ingredient and Impurities in Metarylpicoxamid Technical Grade Active Ingredient (220335 study)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247566
Title
XDE-747 Raw Material SDS
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247535
Title
Part 2 Chemistry and Manufacture - Metarylpicoxamid - Confidential Appendix
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247536
Title
Metarylpicoxamid Declaration of Composition
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247537
Title
Determination of Melting Temperature of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247538
Title
Determination of Boiling Temperature of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247539
Title
Determination of Bulk Density of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247540
Title
Determination of Vapour Pressure of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247541
Title
Determination of Appearance of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247542
Title
Determination of Appearance of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247543
Title
Determination of Spectra (UV-Vis, IR, NMR And MS) of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247544
Title
Determination of Water Solubility of XR-747
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247545
Title
Determination of Organic Solvent Solubility of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247546
Title
Determination of N-Octanol/Water Partition Coefficient of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247547
Title
Hydrolysis of 14C-XDE-747 at pH 2, 4, 7, and 9
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247548
Title
Aqueous Photolysis of 14C-XDE-747 in pH 4 Buffer Under Xenon Light
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247549
Title
Determination of Dissociation Constant of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247550
Title
XDE-747 TGAI: Determination of Thermal Stability and Stability in Air
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247551
Title
Determination of Flammability of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247552
Title
Explodability Testing on a Sample of XDE-747 TGAI
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247553
Title
Determination of Oxidation/Reduction of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247554
Title
Determination of Surface Tension of XDE-747 PAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247555
Title
Determination of Surface Tension of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247556
Title
Determination of pH of XDE-747 TGAI
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247534
Title
Part 2 Chemistry and Manufacture - Metarylpicoxamid
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247575
Title
In Silico Evaluation of the Genotoxicological Relevance of Metarylpicoxamid (XDE-747) and its technical impurities 476-XDE-747-Ta, 680-XDE-747-Tb, 763-Np3-T, X12644507, X12690889, and X12796239
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247558
Title
Classification of Corrosion to Metals of XDE-747
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247559
Title
X12644507: Determination of Spectra
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247560
Title
X12644507: Determination of NMR and MS Spectra
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247561
Title
Determination of Organic Solvent Solubility of X12644507
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247562
Title
Determination of Octanol/Water Partition Coefficient of X12644507
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247563
Title
X12644507: Determination of Dissociation Constants in Water
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247564
Title
Determination of Vapour Pressure of X12644507
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247565
Title
Determination of Water Solubility of X12644507
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247557
Title
Storage Stability of Technical Grade Metarylpicoxamid
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Date
Application Date
Application No
Application Number
137590
Product/Active constituent Name
Application Product Name
GF-4898 Fungicide
Application Date
Application Number
137590
Application Product Name
GF-4898 Fungicide
Application details
Product name:
GF-4898 Fungicide
Product number:
93003
Applicant Name:
CORTEVA AGRISCIENCE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of GF-4898 Fungicide, an emulsifiable concentrate for the control of Asian soybean rust in soybean, in conjunction with approval of metarylpicoxamid
Description of data provided:
Data no
247579
Title
Method Validation for the Determination of XDE-747 in GF-4898 (AM-210736 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247580
Title
Method Validation for the Determination of X12644507 in GF-4898 (AM-210741 method)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247576
Title
Part 2 Chemistry and Manufacture - GF-4898
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247577
Title
Determination of Physicochemical Properties of GF-4898
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
247578
Title
Accelerated Storage Stability for Two Weeks at 54?C of K6B-3-2 (GF-4898) in Vented F-HDPE and Vented PE/PA
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271742
Title
XDE-747 (GF-4429) Dose Response against PHAKPA on Soybean, Brazil 2019/20. ARM Trial Report: LA20K6B001F-FPG2023
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271743
Title
XDE-747 (GF-4429) Dose Response against PHAKPA on Soybean, Brazil 2019/20. ARM Trial Report: LA20K6B001F-GCH2008
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271744
Title
XDE-747 (GF-4429) Dose Response against PHAKPA on Soybean, Brazil 2019/20. ARM Trial Report: LA20K6B001F-HOG2015
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271745
Title
XDE-747 (GF-4429) Dose Response against PHAKPA on Soybean, Brazil 2019/20. ARM Trial Report: LA20K6B001F-LJK2007
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271746
Title
Dose Response of XDE-747 (GF-4429) against Soybean Rust Official Reports, Brazil 2020/21. ARM Trial Report: LA21K6B001F-AVF2109
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271747
Title
Dose Response of XDE-747 (GF-4429) against Soybean Rust Official Reports, Brazil 2020/21. ARM Trial Report: LA21K6B001F-DSF2101
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271748
Title
Dose Response of XDE-747 (GF-4429) against Soybean Rust Official Reports, Brazil 2020/21. ARM Trial Report: LA21K6B001F-FPG2102
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271749
Title
Dose Response of XDE-747 (GF-4429) against Soybean Rust Official Reports, Brazil 2020/21. ARM Trial Report: LA21K6B001F-GCH2127
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271750
Title
Dose Response of XDE-747 (GF-4429) against Soybean Rust Official Reports, Brazil 2020/21. ARM Trial Report: LA21K6B001F-LCS2101_2
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271751
Title
Dose Response of XDE-747 (GF-4429) against Soybean Rust Official Reports, Brazil 2020/21. ARM Trial Report: LA21K6B001F-LJK21311
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271752
Title
Dose Response of XDE-747 (GF-4898) on Soybean Disease Official Reports, Paraguay 2021/22. ARM Trial Report: PY22K6B023
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271753
Title
Dose Response of XDE-747 (GF-4898) on Soybean Disease Official Reports, Paraguay 2021/22. ARM Trial Report: PY22K6B023-ORA10
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271754
Title
Dose Response of XDE-747 (GF-4898) on Soybean Disease Official Reports, Paraguay 2021/22. ARM Trial Report: PY22K6B023-ORA11
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271755
Title
Dose Response of XDE-747 (GF-4898) on Soybean Disease Official Reports, Paraguay 2021/22. ARM Trial Report: PY22K6B023-ORA12
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271756
Title
XDE-747 Aust. Soybeans Efficacy on Powdery Mildew. Kalyx ARM Trial Report: KA20-1788
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271757
Title
XDE-747 Aust. Soybeans Efficacy on Powdery Mildew. Kalyx ARM Trial Report: KA21-0160
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271758
Title
XDE-747 Aust. Soybeans Efficacy on Powdery Mildew. Kalyx ARM Trial Report: KA21-0176
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271759
Title
XDE-747 Aust. Soybeans Efficacy on Powdery Mildew. Kalyx ARM Trial Report: KA21-0177
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271760
Title
XDE-747 Aust. Soybeans Efficacy on Powdery Mildew. Kalyx ARM Trial Report: KA22-1571
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271761
Title
Dose Response of XDE-747 (GF-4429) against CORYCA, SEPTGL, CERCKI and MCRSDI on Soybean, Brazil 2019/20. ARM Trial Report: LA20K6B002F-SYU20021
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271762
Title
Dose Response of XDE-747 (GF-4429) against late cycle Disease on Soybean, Official Report, Brazil 2020/21. ARM Trial Report: LA21K6B002F-GCH2128
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271763
Title
Dose Response of XDE-747 (GF-4429) against late cycle Disease on Soybean, Official Report, Brazil 2020/21. ARM Trial Report: LA21K6B002F-GCH2129
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271764
Title
Dose Response of XDE-747 (GF-4429) against late cycle Disease on Soybean, Official Report, Brazil 2020/21. ARM Trial Report: LA21K6B002F-LJK21313
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
271741
Title
Part 5 Efficacy Crop Safety - GF-4898
Study date
2024
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256132
Title
[14C]XDE 747 ? Bioaccumulation in Bluegill Sunfish (Lepomis macrochirus): Aqueous Exposure
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256130
Title
Ready Biodegradability of XDE-747 and its Metabolite X12664507 in the CO2 Evolution Test according to OECD 301B (July 1992)
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256123
Title
[14C]XDE-747 (Two Labels) Aerobic Degradation and Metabolism in Four Aerobic Soils (Three EU and One US Soil) and One Sterile Soil at 20 ?C in the Dark
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256124
Title
[14C] XDE-747: Anaerobic Transformation in Soil
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
273853
Title
[14C] XDE-747 Aerobic Transformation in Two Aquatic Sediment Systems
Study date
2024
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256129
Title
[14C]XDE-747 Anaerobic Transformation in Two Aquatic Sediment Systems
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256131
Title
Estimation of the Photochemical Oxidation Rates of XDE-747 and its metabolite X12644507
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256126
Title
[14C]XDE-747 and [14C]X12644507: Adsorption to and Desorption from 7 soils (OECD 106)
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256127
Title
Hydrolysis of 14C-XDE-747 at pH 2, 4, 7, and 9
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256128
Title
Aqueous Photolysis of 14C-XDE-747 in pH 4 Buffer Under Xenon Light
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256125
Title
[14C]XDE-747: Phototransformation of Chemicals on Soil Surfaces
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256144
Title
XDE-747: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256145
Title
XDE-747: Acute Toxicity to Fathead Minnow (Pimephales promelas) Under Flow-Through Conditions
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256146
Title
XDE-747: Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Flow-Through Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256147
Title
GF-4898: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) Under Static-Renewal Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256149
Title
XDE-747: Acute Toxicity to Water Fleas (Daphnia magna) Under Flow Through Conditions
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256150
Title
XDE-747 - Acute Toxicity to Mysids (Americamysis bahia) Under Flow Through Conditions
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256151
Title
XDE-747: Acute Toxicity to Midge (Chironomus riparius) Under Static-Renewal Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256152
Title
XDE-747: Acute Toxicity Test to Eastern Oyster (Crassostrea virginica) Under Flow-Through Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256153
Title
GF-4898: Acute Toxicity to Water Fleas (Daphnia magna) Under Static-Renewal Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256154
Title
GF-4898: Acute Toxicity to Mysids (Americamysis bahia) Under Static Renewal Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256155
Title
XDE-747 - Full Life-Cycle Toxicity to Water Fleas (Daphnia magna) Under Flow-Through Conditions
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256156
Title
XDE-747 - Life-Cycle Toxicity Test with Mysids (Americamysis bahia)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256157
Title
XDE-747: Sediment-Water Chironomid Toxicity Test Using Spiked Water
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256158
Title
XDE-747 ? Sediment-Water Chironomid Toxicity Test Using Spiked Sediment
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256159
Title
XDE-747 - Toxicity to the Freshwater Green Alga, Raphidocelis subcapitata
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256160
Title
XDE-747 - Toxicity to the Freshwater Diatom, Navicula pelliculosa
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256161
Title
XDE-747 ? Toxicity to the Freshwater Marine Diatom, Skeletonema costatum
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256162
Title
XDE-747 - Toxicity to the Freshwater Cyanobacterium, Anabaena flos-aquae
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256163
Title
GF-4898 ? Toxicity to the Freshwater Green Alga, Raphidocelis subcapitata
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256164
Title
GF-4898 - Toxicity to the Freshwater Diatom, Navicula pelliculosa
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256165
Title
GF-4898 - Toxicity to the Marine Diatom, Skeletonema costatum
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256166
Title
GF-4898 - Toxicity to the Freshwater Cyanobacterium, Anabaena flos-aquae
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256167
Title
XDE-747: 7-Day Toxicity Test with Duckweed (Lemna gibba)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256168
Title
GF-4898: 7-Day Toxicity Test with Duckweed (Lemna gibba)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256148
Title
XDE-747 - Early Life-Stage Toxicity Test with Rainbow Trout (Oncorhynchus mykiss)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256169
Title
Acute Toxicity of XDE-747 to the Honeybee Apis mellifera L. under Laboratory Conditions
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256170
Title
XDE-747: Acute toxicity to the bumble bee Bombus terrestris L. under laboratory conditions
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256171
Title
Acute Toxicity of X12644507 to the Honeybee Apis mellifera L. under Laboratory Conditions
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256172
Title
GF-4898: Acute Toxicity of GF-4898 to the Honeybee Apis mellifera L. under Laboratory Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256173
Title
XDE-747: Chronic toxicity to the honey bee Apis mellifera L. under laboratory conditions
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256174
Title
XDE-747: Single Exposure of Honey Bee (Apis mellifera L.) Larvae Under Laboratory Conditions
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256175
Title
XDE-747: Repeated exposure of Honey Bee Larvae (Apis mellifera L.) under laboratory conditions
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256176
Title
GF-4898: Residual Toxicity to the Honey Bee, Apis mellifera L., Following Foliar Application to Alfalfa Leaves and Bee Exposure under Laboratory Conditions
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256182
Title
X12690747: Acute Toxicity to the Earthworm Eisenia andrei in Artificial Soil
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256183
Title
X12644507: Acute Toxicity to the Earthworm Eisenia andrei in Artificial Soil
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256184
Title
XDE-747: Effects on Reproduction and Growth of Earthworms Eisenia andrei in Artificial Soil
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256185
Title
GF-4898: Acute Toxicity to the Earthworm Eisenia andrei in Artificial Soil
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256186
Title
GF-4898: Effects on Reproduction and Growth of Earthworms Eisenia andrei in Artificial Soil
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256187
Title
XDE-747: Effects of XDE-747 on the reproduction of the collembolan Folsomia candida
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256188
Title
GF-4898: Effects on Reproduction of the Collembola Folsomia candida in Artificial Soil
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256180
Title
GF-4898: Effects on the Lacewing Chrysoperla carnea (Neuroptera:Chrysopidae), Extended Laboratory Study - Dose Response Test
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256181
Title
GF-4898: Effects on the Reproduction of Rove Beetles Aleochara bilineata ? Extended Laboratory Study ? Dose Response Test
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256177
Title
GF-4898: Effects on the Parasitoid Aphidius rhopalosiphi (Hymenoptera: Braconidae) in the Laboratory. A Dose Response Test on Glass Plates
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256178
Title
GF-4898: Effects on the Parasitoid Aphidius rhopalosiphi (Hymenoptera: Braconidae) in the Laboratory. A Dose Response Test on Glass Plates
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256179
Title
GF-4898: Effects on the Predatory Mite Typhlodromus pyri (Acari: Phytoseiidae) in the Laboratory. A Dose Response Test on Glass Plates
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256189
Title
XDE-747: Effects of XDE-747 on Reproduction of the Predatory Mite Hypoaspis aculeifer
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256190
Title
GF-4898: Effects on Reproduction of the Predatory Mite Hypoaspis aculeifer in Artificial Soil
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256191
Title
X12690747: Effects on the Activity of the Soil Microflora in the Laboratory
Study date
2019
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256192
Title
X12644507: Effects on the Activity of the Soil Microflora in the Laboratory
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256193
Title
GF-4898: Effects on the Activity of the Soil Microflora in the Laboratory
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256194
Title
GF-4898 + Aureo: Terrestrial Non-Target Plant Test ? Seedling Emergence and Seedling Growth
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256195
Title
GF-4898 + Aureo: Terrestrial Non-Target Plant Test - Vegetative Vigor
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256196
Title
X12690747: Toxicity to Activated Sludge in a Respiration Inhibition Test
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256137
Title
XDE 747: Acute Oral Toxicity Test with Northern Bobwhite (Colinus virginianus)
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256138
Title
XDE-747: Acute Oral Toxicity Test with Mallard (Anas platyrhynchos)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256139
Title
GF-4898: Acute Oral Toxicity Test with Northern Bobwhite (Colinus virginianus)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256142
Title
XDE-747: Reproductive Toxicity Test with the Northern Bobwhite (Colinus virginianus)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256143
Title
XDE-747: Reproductive Toxicity Test with the Mallard (Anas platyrhynchos)
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256140
Title
XDE-747: Northern Bobwhite (Colinus virginianus) Dietary Toxicity Test (LC50)
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256141
Title
XDE-747 TGAI: Mallard Duck (Anas platyrhynchos) Dietary Toxicity Test (LC50)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245569
Title
BICON Declaration
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245568
Title
Project Plan for the Item 27 application for metarylpicoxamid GF-4898 Fungicide
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245571
Title
XDE-747: Pharmacokinetic and Pilot Excretion Screen in the Rat
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245572
Title
14C-XDE-747: Absorption, Distribution, Metabolism, and Elimination in the Sprague-Dawley Rat
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245573
Title
XDE-747: Pharmacokinetic and Pilot Excretion Screen in Crl:CD1(ICR) Mice
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245574
Title
XDE-747: Pharmacokinetic and Pilot Excretion Screen in the Rabbit
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245575
Title
XDE-747: Multispecies In Vitro Metabolism in Hepatocytes
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245576
Title
XDE-747: Chemical Stability in Gastrointestinal Fluids from Rat, Mouse, Rabbit and Dog
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256116
Title
Position Paper: X12777891 Endogenous Levels in Soybean ? Brazilian, Argentinian and Australian Residue Trials
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256106
Title
A Nature of the Residue Study with [14C]-XDE-747 Applied to Soybeans
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256107
Title
[14C]-XDE-747: Uptake and Metabolism in Confined Rotational Crops
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256108
Title
A Nature of the Residue Study with [14C]-XDE-747 Dosed to the Laying Hen
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256109
Title
A Nature of the Residue Study with [14C]-XDE-747 Dosed to the Ruminant
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245664
Title
Part 6 - OH&S
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245635
Title
GF-4898: In Vitro Percutaneous Absorption of XDE-747 in Human Skin
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256110
Title
Validation Method for the Determination of XDE-747 and its Metabolites in Crop Matrices
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256111
Title
Independent Laboratory Validation of Multi-Residue Method QuEChERS for Determination of XDE-747 and its metabolite X12644507 in Different Matrices of Plant Origin
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256112
Title
Method Validation for the Determination of XDE-747 and One Metabolite (X12644507) in Animal Matrices
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256113
Title
Independent Laboratory Validation of XDE-747 and its Metabolite in Animal Matrices
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256121
Title
XDE-747 Livestock Feeding Study: Magnitude of Residue in Milk, Muscle, Liver, Kidney and Fat of Lactating Dairy Cattle
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256117
Title
Determination of XDE-747 residues in soybean following multiple foliar applications of GF-4898
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256118
Title
GF-4898 and GF-4899 ? Magnitude of Residues of XDE-747, its Metabolites (X12644507, X12777891 and X12774135) and Picoxystrobin in Soybean Forage, Hay and Seeds ? Brazil, 2021
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256119
Title
GF-4898 and GF-4899 ? Magnitude of Residues of XDE-747, its Metabolites (X12644507, X12777891 and X12774135) and Picoxystrobin in Soybean Forage, Hay and Seeds ? Argentina ? 2021/2022
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256120
Title
[14C]-XDE-747 and [14C]-X12644507: Processing Nature of the Residue
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256114
Title
Frozen Storage Stability for the Determination of XDE-747 and its Metabolites in Crop Matrices
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256115
Title
Frozen Storage Stability for the Determination of XDE-747 and its Metabolites in Animal Matrices
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256105
Title
Part 5 Residues and Trade - Metarylpicoxamid GF-4898
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245580
Title
XR-747: Acute Dermal Toxicity ? Fixed Dose Procedure in Rats
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245621
Title
Acute Dermal Toxicity Study of GF-4898 in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245586
Title
XR-747: EpiOcular Eye Irritation Test (EIT) for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245587
Title
Acute Eye Irritation Study of XDE-747 in Rabbits
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245588
Title
XDE-747 (Lot ID 82447951): EpiOcular Eye Irritation Test (EIT) for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eyes Damage
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245589
Title
Acute Eye Irritation Study of XDE-747 in Rabbits (Lot ID: 82447951)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245626
Title
GF-4898: EpiOcular Eye Irritation Test (EIT) for Identifying Chemicals not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245627
Title
GF-4898: Bovine Corneal Opacity and Permeability Assay with Two Time Exposures and Optional Histology
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245581
Title
XDE-747: Inhalation Median Lethal Concentration (LC50) Study in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245622
Title
Acute Inhalation Toxicity Study of GF-4898 in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245577
Title
Acute Oral Toxicity Study of XDE-747 in Rats
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245578
Title
Acute Oral Toxicity Study of XDE-747 in Rats (TSN401344)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245579
Title
Acute Oral Toxicity Study of XDE-747 in Rats (Lot ID: 82447951)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245620
Title
Acute Oral Toxicity Study of GF-4898 in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245582
Title
XR-747: Skin Irritation Test (SIT) Using the Epiderm Skin Model
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245583
Title
Acute Dermal Irritation Study of XDE-747 in Rabbits
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245584
Title
XDE-747 (Lot ID 82447951): Skin Irritation Test (SIT) Using the EpiDerm Skin Model
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245585
Title
Acute Dermal Irritation Study of XDE-747 in Rabbits (Lot ID: 82447951)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245623
Title
GF-4898: Skin Irritation Test (SIT) Using the EpiDerm Skin Model
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245624
Title
GF-4898: In Vitro Skin Corrosion Assay Using the EpiDerm Skin Model (EPI-200): 3- and 60-Minute Exposure Protocol
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245625
Title
Acute Dermal Irritation Study of GF-4898 in Rabbits
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245628
Title
Acute Eye Irritation Study of GF-4898 in Rabbits
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245590
Title
XDE-747: Direct Peptide Reactivity Assay (DPRA)
Study date
2021
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245591
Title
XDE-747: Induction of Antioxidant-Response-Element Dependent Gene Activity and Cytotoxicity (Using MTT) in the Keratinocyte ARE-Reporter Cell Line KeratinoSens
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245592
Title
Skin Sensitisation Study of XDE-747 by Local Lymph Node Assay in Mice
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245593
Title
Skin Sensitisation Study of XDE-747 by Local Lymph Node Assay in Mice (Lot ID: 82447951)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245629
Title
Skin Sensitisation Study of GF-4898 by Local Lymph Node Assay in Mice
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245630
Title
GF-4898: Direct Peptide Reactivity Assay (DPRA)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245631
Title
GF-4898: Induction of Antioxidant-Response-Element Dependent Gene Activity and Cytotoxicity (Using MTT) in the Keratinocyte ARE-Reported Cell Line KeratinoSens IIIA 7
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245610
Title
XDE-747: Carcinogenicity 18-Month Feeding Study in Mice
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245601
Title
XDE-747: Repeated Dose Toxicity Study by Oral (Capsule) Administration to Beagle Dogs for 13 Weeks
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245602
Title
XDE-747: Metabolite Identification and Analysis of XDE 747 and Selected Metabolites in Blood and Urine from the Repeat Toxicity Study by Oral (Capsule) Administration to Beagle Dogs for 13 Weeks
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245609
Title
XDE-747: A 2-Year Dietary Combined Chronic Toxicity/Carcinogenicity Study in CD Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245611
Title
XR-747: Pilot Developmental Toxicity Study in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245612
Title
XDE-747: Developmental Toxicity Study in Crl:CD(SD) Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245613
Title
An Oral (Dietary) Dose Range-Finding Prenatal Developmental Toxicity Study of Effects of XR-747 in Rabbits
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245614
Title
An Oral (Dietary) Prenatal Developmental Toxicity Study of XDE-747 in Rabbits
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245615
Title
XR-747: Reproduction/Developmental Toxicity Screening Test in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245616
Title
XDE-747: Multigeneration Reproduction Study in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245632
Title
GF-4898: In Vitro Mammalian Cell Micronucleus Test in Human Peripheral Blood Lymphocytes
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245633
Title
GF-4898: Bacterial Reverse Mutation Test
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245603
Title
XR-747: Bacterial Reverse Mutation Test
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245604
Title
XDE-747 (Lot ID 82447951): Bacterial Reverse Mutation Test Using Salmonella typhimurium and Escherichia Coli WP2uvrA (pKM101)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245605
Title
XR-747: In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT) Assay with Duplicate Cultures
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245606
Title
XDE-747 (Lot ID: 82447951): In vitro Mammalian Cell Gene Forward Mutation Test at The HPRT Locus by using Chinese Hamster Ovary (CHO)-K1 Cell Line
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245607
Title
XR-747: In Vitro Mammalian Chromosomal Aberration Test in Human Peripheral Blood Lymphocytes
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245608
Title
XDE -747 (Lot ID 82447951): In Vitro Mammalian Cell Micronucleus Test in Human Peripheral Blood Lymphocytes
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245570
Title
Part 3 Toxicology - Metarylpicoxamid
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245634
Title
SDS documents for GF-4898 and its ingredients
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245618
Title
An Oral (Dietary) 14-Day Palatability and Maximum Dose Tolerability Study of X12690747 in Nonpregnant Rabbits
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245619
Title
Part 3 Toxicology - GF-4898
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245617
Title
X12690747: Repeated Dose Oral Toxicity 7- to 14-Day Triggered Feeding Range-Finding Study in Female Mice
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245600
Title
XR-747: Dose Range-Finding and 28-Day Constant Repeat Dose Study by Oral (Capsule) Administration to Beagle Dogs
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245594
Title
X12690747: Repeated Dose Oral Toxicity 28-Day Triggered Feeding Study in Rats
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245595
Title
XDE-747: Analysis of XDE-747 and Selected Metabolites in Blood and Urine from the Repeated-Dose Oral Toxicity 28 Day Triggered Feeding Study in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245596
Title
XR-747: Sub Chronic Toxicity 90 Day Feeding Study in Rats
Study date
2020
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245597
Title
XDE-747: Analysis of XDE-747 and Selected Metabolites in Blood and Urine from the Subchronic Toxicity 90-day Feeding Study in Rats
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245598
Title
XR-747: Subchronic Toxicity 90-Day Feeding Study in Mice with Micronucleus Evaluation
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
245599
Title
XDE-747: Evaluation of Small Intestine and Reproductive Organ Toxicity Findings in Female Mice Following 90 Days of Dietary Exposure
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256122
Title
Part 7 Environment - Metarylpicoxamid GF-4898
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256133
Title
Validation Method for Determination of XDE-747 and its Metabolites in Soil
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256134
Title
Validation Method for Determination of XDE-747 and its Metabolites in Water
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256135
Title
Development and Validation of the Analytical Method for the Determination of XDE-747 and its Metabolite X12644507 in Air
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
256136
Title
Development and Validation of the Analytical Method for the Determination of XDE-747 and its Metabolite X12644507 in Body Fluids (Blood and Urine)
Study date
2022
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Date
Application Date
Application No
Application Number
137869
Product/Active constituent Name
Application Product Name
TEMEPHOS SMALL HIVE BEETLE GRANULE
Application Date
Application Number
137869
Application Product Name
TEMEPHOS SMALL HIVE BEETLE GRANULE
Application details
Product name:
TEMEPHOS SMALL HIVE BEETLE GRANULE
Product number:
93064
Applicant Name:
TERMSEAL AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 15 g/kg soluble granule for use as a larvicide around bee hives for the control of Small Hive Beetle.
Reference details:
47568 - COOPERS ASSASSIN SHEEP DIP
62971 - DAVID GRAYS GRAYBATE 10 SG MOSQUITO LARVICIDE GRANULES
62972 - DAVID GRAYS GRAYBATE 50 SG MOSQUITO LARVICIDE GRANULES
Active constituents:
Active constituent name
45664 - TEMEPHOS
Description of data provided:
Data no
246252
Title
Method Validation
Study date
November 2922
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246253
Title
CoA for the reference Temephos used in the stability and validation studies
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246254
Title
Chromatograms
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246247
Title
Part 2 Chemistry dossier
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246248
Title
SDS-PDS for non-active ingredients
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246249
Title
Temephos CoA for product formulation
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246250
Title
Manufacturing Process and quality control
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246251
Title
Storage Stability Report
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246263
Title
Part 8 Efficacy and Safety dossier
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246264
Title
In-soil temephos-based larvaecide trial on small hive beetle (Aethina tumida) larvae
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246261
Title
Apis mellifera necropsy trial on temephos-based larvaecide for Aethina tumida larvae
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246258
Title
Part 7 Environmental dossier
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246259
Title
Occupational Health and Safety Assessment Coopers Assassin Sheep Dip
Study date
2009
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246260
Title
Avian observational study on temephos-based larvaecide for Aethina tumida larvae
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246246
Title
Executive Summary
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246262
Title
TEMEPHOS SMALL HIVE BEETLE GRANULE Draft Label
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246255
Title
Part 6 OH and S dossier
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Data no
246256
Title
Occupational Health and Safety Assessment Coopers Assassin Sheep Dip
Study date
2009
Auth party contact address
-
Data no
246257
Title
SDS-PDS for non-active ingredients
Study date
November 2022
Auth party contact address
8 Trade Circuit WAUCHOPE Australia
Date
Application Date
Application No
Application Number
137538
Product/Active constituent Name
Application Product Name
KEYBRI Ultra Fungicide
Application Date
Application Number
137538
Application Product Name
KEYBRI Ultra Fungicide
Application details
Product name:
KEYBRI Ultra Fungicide
Product number:
92989
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 250 g/L mandipropamid + 30 g/L oxathiapiprolin suspension concentrate product for the control of downy mildew in grapes.
Reference details:
63052 - REVUS FUNGICIDE
68375 - ZORVEC ENICADE FUNGICIDE
63053 - REVUS MZ FUNGICIDE
85818 - ORONDIS FLEXI Fungicide
Active constituents:
Active constituent name
63073 - MANDIPROPAMID
Active constituent name
69752 - OXATHIAPIPROLIN
Active constituent name
69756 - OXATHIAPIPROLIN
Description of data provided:
Data no
261786
Title
Certificate of Analysis QGU 42
Study date
Mar 2022
Auth party contact address
Level 9, 67 Albert Avenue, Chatswood, 2067, NSW, Australia
Data no
261787
Title
Certificate of Analysis Oxathiapiprolin
Study date
Dec 2021
Auth party contact address
Level 9, 67 Albert Avenue, Chatswood, 2067, NSW, Australia
Data no
261788
Title
Certificate of Analysis NOA446510
Study date
Nov 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245308
Title
Analytical Method SF-840/1 Oxathiapiprolin and Mandipropamid in Formulation SC (030/250), by HPLC
Study date
Jan 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245309
Title
A21591C ??? Validation of Analytical Method SF-840/1
Study date
Jan 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245301
Title
A21591C ??? Corrosion Characteristics of Batch SFI003-097-003A after Storage in Packaging Made of HDPE for 2 Weeks at 54 ??C
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245292
Title
A21591C ??? Physical and Technical Properties of Batch SFI003-097-003A
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245293
Title
A21591C - Safety Study
Study date
Mar 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245294
Title
A21591C ??? Physico-Chemical Characteristics of Batch SFI003-097-003A
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245295
Title
A21591C ??? Chemical Characterization of Batch SFI003-097-003A
Study date
Nov 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245296
Title
A21591C - Oxidation/Reduction: Chemical Incompatibility
Study date
Mar 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245297
Title
Report on IR Spectra for A21591 C [oxathiapiprolin/mandipropamid SC (030/250)] formulation
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245298
Title
SPECIFICATION FOR REGISTRATION
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245310
Title
Safety Data Sheets
Study date
Aug 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245291
Title
Part 2 - Chem
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245302
Title
A21591C - Storage Stability and Shelf Life Statement (2 Years 20 ??C) in Packaging Made of HDPE
Study date
Nov 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245303
Title
A21591C - Storage Stability and Shelf Life Statement (2 Years 20 ??C) in Packaging Made of PET
Study date
Nov 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245304
Title
A21591C - Storage Stability and Shelf Life Statement (2 Years 25 ??C) in Packaging Made of PET
Study date
Nov 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245305
Title
A21591C - Storage Stability and Shelf Life Statement (2 Years 25 ??C) in Packaging Made of HDPE
Study date
Nov 2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245306
Title
A21591C - Storage Stability and Shelf Life Statement (3 Years 25 ??C) in Packaging Made of HDPE
Study date
Jun 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245307
Title
A21591C - Storage Stability and Shelf Life Statement (3 Years 25 ??C) in Packaging Made of PET
Study date
Jun 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245299
Title
A21591C - Storage Stability and Shelf Life Statement (2 Weeks 54 ??C) in Packaging Made of PET according to CIPAC MT 46.3
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245300
Title
A21591C - Storage Stability and Shelf Life Statement (2 Weeks 54 ??C) in Packaging Made of HDPE according to CIPAC MT 46.3
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245356
Title
Efficacy of SYN546539 in Vines for downy mildew control
Study date
Jun 2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245357
Title
Efficacy of SYN546539 in Vines for downy mildew control
Study date
Jul 2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245358
Title
Efficacy of Orondis Ultra (A21591C) in vines for downy mildew control
Study date
Jul 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245359
Title
Efficacy of Orondis Ultra (A21591C) in vines for downy mildew control
Study date
Jun 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245360
Title
Efficacy of Orondis Ultra (A21591C) in vines for downy mildew control
Study date
Jun 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245361
Title
Efficacy of Orondis Ultra (A21591C) in vines for downy mildew control
Study date
Jul 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245362
Title
Efficacy of Orondis Ultra (A21591C) in vines for downy mildew control
Study date
Jul 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245363
Title
Comparison of A21591C 280 SC with Revus 250 SC for the control of downy mildew (Plasmopara viticola) in wine grapes cv. Merlot
Study date
Jul 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245364
Title
Efficacy of Orondis Ultra (A21591C) in vines for downy mildew control + Ridomil variant
Study date
Apr 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245355
Title
Part 8 - Efficacy Safety
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245365
Title
Crop safety of Orondis Ultra in grapes, Australia 2021
Study date
Feb 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245366
Title
Crop safety of Orondis Ultra in grapes, Australia 2021
Study date
Jun 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245367
Title
Registration trials in grapes 20- SYN-023
Study date
Aug 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245368
Title
Registration trials in grapes 21-SYN-003
Study date
Sep 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245332
Title
Mandipropamid 250 g/L SC Formulation 6-Years Long Term Residue Study in or on Soil in Switzerland
Study date
Nov 2009
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245335
Title
Oxathiapiprolin/Mandipropamid (SC A21591C) - Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss)
Study date
Aug 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245336
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ??? A 96-Hour Static Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus)
Study date
Jul 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245337
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Acute Toxicity to Carp (Cyrpinus carpio) in a 96-Hour Test
Study date
Sep 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245338
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Acute Toxicity to Carp (Cyrpinus carpio) in a 96-Hour Test
Study date
Aug 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245339
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ???????? Toxicity to Pseudokirchneriella subcapitata in a 96-Hour Algal Growth Inhibition Test
Study date
Sep 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245340
Title
Oxathiapiprolin/mandipropamid SC (A21591C) - Acute Toxicity to the Honeybee Apis mellifera L. under Laboratory Conditions
Study date
Jun 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245341
Title
Mandipropamid ???????? Single Exposure to the Honey Bee (Apis mellifera L.) Larvae under Laboratory Conditions
Study date
Feb 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245342
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Chronic toxicity to the honey bee Apis mellifera L. in a 10-day continuous laboratory feeding study
Study date
Oct 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245343
Title
Mandipropamid - Chronic toxicity to the honey bee Apis mellifera L. in a 10 day continuous laboratory feeding study
Study date
Mar 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245344
Title
Mandipropamid ???????? Repeated Exposure to the Honey Bee (Apis mellifera L.) Larvae under Laboratory Conditions (until Adult Emergence up to Day 22)
Study date
Feb 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245346
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ???????? A Rate-Response Extended Laboratory Study of the Effects of Fresh Residues on the Parasitic Wasp Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Study date
Jul 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245347
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ???????? A Rate-Response Extended Laboratory Study to Determine the Effects of Fresh Residues on the Predatory Mite Typhlodromus pyri (Acari: Phytoseiidae)
Study date
May 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245345
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ???????? A Rate-Response Extended Laboratory Study to Evaluate the Effects of Fresh Residues on the Green Lacewing, Chrysoperla carnea (Neuroptera, Chrysopidae)
Study date
Aug 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245353
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Effects on the Reproduction of the Predatory Mite Hypoaspis aculeifer
Study date
Mar 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245352
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Effects on the Reproduction of the Collembolan Folsomia candida
Study date
Feb 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245354
Title
Oxathiapiprolin/mandipropamid SC (A21591C) ???????? Effects on the Activity of Soil Microflora (Nitrogen and Carbon Transformation Tests)
Study date
Jul 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245331
Title
Part 7 - Env
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245348
Title
Oxathiapiprolin/mandipropamid SC (A21591C) - Acute Toxicity to the Earthworm Eisenia andrei in Artificial Soil
Study date
Aug 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245349
Title
CGA380778 - Sublethal Effects on the Reproduction of the Earthworm Eisenia andrei in Artificial Soil
Study date
Mar 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245350
Title
CGA380775 - Sublethal Effects on the Reproduction of the Earthworm Eisenia andrei in Artificial Soil
Study date
Mar 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245351
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Sublethal Effects on the Reproduction of the Earthworm Eisenia andrei in Artificial Soil
Study date
Mar 2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245333
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - An Acute Oral Toxicity Study with the Northern Bobwhite Using a Sequential Testing Procedure
Study date
Jul 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245334
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - An Acute Oral Toxicity Study with the Mallard Using a Sequential Testing Procedure
Study date
Jul 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245289
Title
Letter of access for oxathiapiprolin registration data
Study date
Aug 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245290
Title
KEYBRI Ultra - proposed label
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245329
Title
Part 6 - WHS
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245330
Title
Mandipropamid/Oxathiapiprolin SC (A21591C) - The In Vitro Percutaneous Absorption of Radiolabelled Mandipropamid and Radiolabelled Oxathiapiprolin in Concentrate Formulation and Two In-Use Dilutions Through Human Split-Thickness Skin
Study date
Feb 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245320
Title
Mandipropamid - Analytical Method GRM001.07A for the Determination of Residues of Mandipropamid in Crop Matrices
Study date
Apr 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245321
Title
Mandipropamid - Validation of Analytical Method GRM001.07A for the Determination of Residues of Mandipropamid in Crop Matrices
Study date
Apr 2015
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245322
Title
Mandipropamid - Analytical Method GRM001.07B for the Determination of Residues of Mandipropamid in Crop Matrices
Study date
Sep 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245323
Title
Mandipropamid ??? Validation of Analytical Method GRM001.07A for the Determination of Mandipropamid in Crop Matrices by LC-MS/MS
Study date
Oct 2019
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245324
Title
Registration trials in grapes 20- SYN-023
Study date
Aug 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245325
Title
Registration trials in grapes 21-SYN-003
Study date
Sep 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245326
Title
A21591 - Magnitude of Residues of SYN546539 and Mandipropamid in Grape Fruits - Brazil, 2015-16
Study date
Feb 2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245327
Title
A21591 - Magnitude of Residues of SYN546539 and Mandipropamid in Grape Fruits - Brazil, 2016-17
Study date
Mar 2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245902
Title
MAGNITUDE OF RESIDUES OF DPX-QGU42 AND ITS METABOLITES IN PROCESSED COMMODITIES OF GRAPES FOLLOWING APPLICATION OF DPX-QGU42 100 G/L OD ? EUROPE, 2010-2011
Study date
19 September 2012
Auth party contact address
Level 9, 67 Albert Avenue, Chatswood, 2067, NSW, Australia
Data no
245319
Title
Part 5A - Residues
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245328
Title
Part 5B - Trade
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245313
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ??? Acute Dermal Toxicity Study in Rat
Study date
Apr 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245316
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) - Acute Eye Irritation Study in Rabbits
Study date
Apr 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245314
Title
Oxathiapiprolin/Mandipropamid SC - Acute Inhalation Toxicity in Rats
Study date
Apr 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245312
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ??? Acute Oral Toxicity Study in the Rat (Up and Down Procedure)
Study date
Apr 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245315
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ??? Primary Skin Irritation Study in Rabbits
Study date
Apr 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245317
Title
Oxathiapiprolin/Mandipropamid SC (A21591C) ??? Skin Sensitisation Test (Local Lymph Node Assay)
Study date
Nov 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245318
Title
Tox database MPD
Study date
Aug 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
245311
Title
Part 3 - Tox
Study date
Oct 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
137640
Product/Active constituent Name
Application Product Name
TEPPAN 50SL Insecticide
Application Date
Application Number
137640
Application Product Name
TEPPAN 50SL Insecticide
Application details
Product name:
TEPPAN 50SL Insecticide
Product number:
68689
Applicant Name:
ISHIHARA SANGYO KAISHA, LTD
Application purpose and description of use:
Variation of product registration and label approval to add extra insect pests and crops
Active constituents:
Active constituent name
70026 - CYCLANILIPROLE
Description of data provided:
Data no
245703
Title
Teppan 50SL Insecticide Part 8 Efficacy Add Crops Oct 22
Study date
2022
Data no
245704
Title
ESSM1 Teppan Efficacy Trial Summaries Pome Fruits Oct 22
Study date
2022
Data no
245705
Title
ESSM2 Teppan Efficacy Trial Summaries Tree Nuts Oct 22
Study date
2022
Data no
245706
Title
ESSM3 Teppan Efficacy Trial Summaries Fruiting Vegs Other Than Cucurbits Oct 22
Study date
2022
Data no
245707
Title
ESSM4 Teppan Efficacy Trial Summaries Brassica & Leafy Vegetables Oct 22
Study date
2022
Data no
245708
Title
ES1 Evaluation of NUL3445 for the Control of Light Brown Apple Moth in Apples.
Study date
2020
Data no
245709
Title
ES2 Evaluation of NUL3445 for the Control of Loopers in Apples.
Study date
2021
Data no
245710
Title
ES3 Evaluation of NUL3445 Efficacy Against Macadamia Seed Weevil in Macadamia. One Field Trial, Pearces Creek, New South Wales, Australia, 2019-2020.
Study date
2020
Data no
245711
Title
ES4 Evaluation of Experimental Insecticides for the Control of Insect Pests in Macadamia.
Study date
2020
Data no
245712
Title
ES5 Evaluation of Experimental Insecticides for the Control of Insect Pests in Nuts.
Study date
2021
Data no
245713
Title
ES6 Evaluation of NUL3445 Efficacy Against Macadamia Seed Weevil in Macadamia. One Field Trial, Ewingsdale, New South Wales, Australia, 2020-2021.
Study date
2021
Data no
245714
Title
ES7 Evaluation of NUL3445 for the Control of Fruit Spotting Bug in Macadamia.
Study date
2019
Data no
245715
Title
ES8 Evaluation of Experimental Insecticides for the Control of Insect Pests in Nuts.
Study date
2021
Data no
245716
Title
ES9 Evaluation of Experimental Insecticides for the Control of Insect Pests in Nuts.
Study date
2022
Data no
245717
Title
ES10 Efficacy of NUL3445 on Spotting Bug in Macadamia.
Study date
2021
Data no
245718
Title
ES11 Efficacy of NUL3445 on Macadamia Nut Borer in Macadamia.
Study date
2020
Data no
245719
Title
ES12 Efficacy of NUL3445 Against Macadamia Nut Borer in Macadamia.
Study date
2020
Data no
245720
Title
ES13 Evaluation of Experimental Insecticides for the Control of Insect Pests in Nuts.
Study date
2020
Data no
245721
Title
ES14 Evaluation of NUL3445 for the Control of Insect Pests in Nuts.
Study date
2022
Data no
245722
Title
ES15 Evaluation of NUL3445 for the Control of Insect Pests in Tree Nuts.
Study date
2022
Data no
245723
Title
ES16 Evaluation of NUL3445 for the Control of Insect Pests in Tree Crops.
Study date
2019
Data no
245724
Title
ES17 Efficacy of IBE 4064 Against Helicoverpa in Protected Pepper Crop. Greece 2014.
Study date
2014
Data no
245725
Title
ES18 Evaluate the Efficacy of IBE 4064 Against Helicoverpa Control in Protected Pepper Crop. Italy 2014.
Study date
2014
Data no
245726
Title
ES19 Efficacy and Selectivity of IBE 4064 Against Helicoverpa sp. In Protected Pepper Crop in South Europe.
Study date
2014
Data no
245727
Title
ES20a Experimental Field Evaluation of the Efficacy and Selectivity of IBE 4064 for Lepidoptera Control on Peppers in Italy.
Study date
2013
Data no
245728
Title
ES20b Experimental Field Evaluation of the Efficacy and Selectivity of IBE 4064 for Lepidoptera Control on Peppers in Italy - Appendices
Study date
2013
Data no
245729
Title
ES21 Field Study to Evaluate the Efficacy and Selectivity of IBE-4064 for the Control of Lepidoptera in Protected Pepper in Spain During 2013.
Study date
2013
Data no
245730
Title
ES22 Efficacy of IBE 4064 Against Spodoptera exigua on Protected Pepper. Spain 2013.
Study date
2013
Data no
245731
Title
ES23 Efficacy of IKI-3106 50SL (IBE 4064) Against Spodoptera sp. in Tomato Under Greenhouse ???????? Dose Base Line ???????? South Zone. Trial season 2012.
Study date
2013
Data no
245732
Title
ES24 Efficacy of IKI-3106 50SL (IBE 4064) Against Spodoptera sp. in Tomato Under Greenhouse ???????? South Zone. Trial season 2012.
Study date
2013
Data no
245733
Title
ES25 Efficacy of IKI-3106 50SL (IBE 4064) Against Tuta absoluta in Tomato Under Greenhouse Dose Base Line ???????? South Zone. Trial Season 2012.
Study date
2013
Data no
245734
Title
ES26 Efficacy of IKI-3106 50SL (IBE 4064) Against Tuta absoluta in Tomato Under Greenhouse Dose Base Line ???????? South Zone. Trial Season 2012.
Study date
2013
Data no
245735
Title
ES27 Efficacy of IKI-3106 50SL (IBE 4064) Against Tuta absoluta in Tomato Under Greenhouse ???????? South Zone. Trial Season 2012.
Study date
2013
Data no
245736
Title
ES28 Efficacy of IKI-3106 50SL (IBE 4064) Against Tuta absoluta in Tomato Under Greenhouse ???????? South Zone. Trial Season 2012.
Study date
2013
Data no
245737
Title
ES32 Evaluation of NUL3445 for the Control of Diamondback Moth in Broccoli. Ford, A. (
Study date
2021
Data no
245738
Title
ES33 Evaluation of NUL3445 for the Control of Diamondback Moth Pests in Broccoli. Ford, A. (
Study date
2022
Data no
245739
Title
ES34 Valuation of Experimental Insecticides for the Control of Insects in Brassica Vegetables.
Study date
2022
Data no
245740
Title
ES35 Evaluation of the Efficacy of NUL3445 for the Control of Cluster Caterpillar in Broccoli.
Study date
2022
Data no
245741
Title
ES36 Evaluation of NUL3445 for the Control of Cabbage Cluster Caterpillar and Diamondback Moth in Brassica Crops.
Study date
2022
Data no
245742
Title
ES37 Evaluation of NUL3445 for the Control of Diamondback Moth in Brassica Crops.
Study date
2022
Data no
245743
Title
ES38 An Evaluation of IKI3106 (Cyclaniliprole) for its Efficacy Against Diamondback Moth (Plutella xylostella), Cabbage White Butterfly (Pieris rapae), Aphid (Aphididae) and Cabbage Whitefly (Aleyrodes proletella) in Vegetable Brassica.
Study date
2020
Data no
245744
Title
ES39 ORI-33_NUNZ1856 NUL3445 (ISK-3016) ISK-3106 Insecticide - An Evaluation of Insect Control in Cabbages.
Study date
2019
Data no
245745
Title
ES40 ISK-3106 Insecticide - An Evaluation of Insect Control in Cabbages.
Study date
2019
Data no
245746
Title
ES41 Evaluation of IKI-3106 050 SL for the Control of Diamondback Moth (Plutella xylostella) in Canola.
Study date
2016
Data no
245747
Title
ES42 Evaluation of IKI-3106 50 SL for the Control of Lepidopteran Pests in Cauliflower cv. Discovery.
Study date
2013
Data no
245748
Title
ES43 Comparison of IKI-3106 50 SL with Coragen 200 SC, Belt 480 SC and Delfin 850 DF for the Control of Diamondback Moth (Plutella xylostella) in Chinese Cabbage (Wombok) cv. Matilda.
Study date
2012
Data no
245749
Title
ES44 Evaluation of NUL3445 50 SL for the Control of Diamondback Moth (Plutella xylostella) in Chinese Cabbage cv. Matilda.
Study date
2021
Data no
245750
Title
ES45 Comparison of NUL 3445 50 SL with Coragen 200 SC and Success Neo 120 SC for the Control of Heliothis (Helicoverpa spp.) Diamondback Moth (Plutella xylostella) Cabbage White Butterfly (Pieris rapae) and Cluster Caterpillar (Spodoptera litura) on Chinese Cabbage cv. Matilda.
Study date
2022
Data no
245751
Title
ES46 An Evaluation of IKI3106 (Cyclaniliprole) for its Efficacy Against Diamondback Moth (Plutella xylostella), Cabbage White Butterfly and Soybean Looper (Thysanoplusia orichalcea) in Forage Brassica.
Study date
2020
Data no
245752
Title
ES47 Evaluate the Efficacy of IBE 4064 50 SL Against Various Lepidoptera in Lettuce.
Study date
2014
Data no
245753
Title
ES48 Efficacy of IKI 3106 Against Various Lepidoptera in Lettuces.
Study date
2016
Data no
245754
Title
ES49 Evaluate the Efficacy and Selectivity of IBE 4064 50 SL Against Various Lepidoptera Control on Lettuce (Lactuca sativa).
Study date
2014
Data no
245755
Title
ES50 Evaluate the Efficacy and Selectivity of IBE 4064 50 SL Against Various Lepidoptera Control on Lettuce (Lactuca sativa).
Study date
2014
Data no
245756
Title
ES51 Evaluate the Efficacy of IBE 4064 50 SL Against Various Lepidoptera in Lettuces.
Study date
2015
Data no
251196
Title
Evaluation of NUL3445 on Non-Target Arthropods (Aphelinus mali) Under Semi Field Conditions.
Study date
2021
Data no
251194
Title
Evaluation of the Crop Safety of NUL3445 050 SL +/- Dragon 700 WG, Polyram 700 DF, Albion Calcium 180 L, Stopit 160 L, Luna Sensation 500 SC, Systhane 400 WP and Activator 900 L on Royal Gala apples Stanthorpe, Qld, 2019-20.
Study date
2020
Data no
251195
Title
Evaluation of Experimental Insecticides for Crop Safety in Tree Crops, One Field Trial, Shepparton, Victoria, Australia, 2020.
Study date
2020
Data no
262984
Title
Terrestrial Field Dissipation of IKI-3106 Applied to Bareground in Seven Springs, NC - USA 2011.
Study date
2013
Data no
262985
Title
Terrestrial Field Dissipation of IKI-3106 Applied to Bareground in Kerman, CA - USA 2011.
Study date
2013
Data no
262986
Title
Terrestrial Field Dissipation of IKI-3106 Applied to Bareground in North Rock, NY - USA 2012.
Study date
2014
Data no
262987
Title
Terrestrial Field Dissipation of IKI-3106 Applied to Bareground in Ephrata, WA - USA 2012.
Study date
2014
Data no
262988
Title
Amended Report - IKI-3106 Technical Grade: Honey Bee (Apis mellifera) Larval Toxicity Test, Repeated Exposure.
Study date
2016
Data no
262989
Title
IKI-3106 50 SL (80 g a.i. Cyclaniliprole / Hectare): A Semi-Field Study to Evaluate Potential Effects on Honeybee, Apis mellifera L. (Hymenoptera: Apidae), Worker Mortality and Brood Development Following the Application on Phacelia tanacetifolia.
Study date
2015
Data no
245759
Title
Teppan Part 7 Environment Oct 22
Study date
2022
Data no
245760
Title
ET1 APVMA Tier 1 Runoff Model for Teppan Oct 22
Study date
2022
Data no
245758
Title
Teppan SDS Jun 20
Study date
2022
Data no
245757
Title
Teppan Part 6 OHS Oct 22
Study date
2022
Data no
245669
Title
Teppan Part 5 Residues Oct 22
Study date
2022
Data no
245670
Title
RS1 Teppan Residues Trials Summaries Pome Fruits Oct 22
Study date
2022
Data no
245671
Title
RS2 Teppan Residues Trials Summaries Tree Nuts Oct 22
Study date
2022
Data no
245672
Title
RS3 Teppan Residues Trials Summaries Fruiting Vegetables Other Than Cucurbits Oct 22
Study date
2022
Data no
245673
Title
RS4 Teppan Residues Trials Summaries Brassica & Leafy Vegetables Oct 22
Study date
2022
Data no
245674
Title
90897 Determination of Residues of IKI-3106 and NK-1375 in Pome Fruit Following Two (2) Applications of IKI-3106 50 SL Applied as a Foliar Spray at Various Timings Before Harvest.
Study date
2013
Data no
245675
Title
90898 Determination of Residues of IKI-3106 and NK-1375 in Apples Following Two (2) Applications of IKI-3106 50SL Applied at Various Timings Prior to Harvest.
Study date
2013
Data no
245676
Title
90891 Magnitude of Residues of IKI-3106 on Apples - USA and Canada in 2012.
Study date
2013
Data no
245677
Title
90892 Magnitude of Residues of IKI-3106 on IKI-3106 50SL (IB3E 4064) Residue Study (at Harvest and Processing) with IKI-3106 50SL (IBE 4064) Applied to Apples in Northern and Southern Europe in 2012.
Study date
2013
Data no
245678
Title
90893 Magnitude of Residues of IKI-3106 on IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Apples in Northern and Southern Europe in 2012.
Study date
2013
Data no
245679
Title
R24 Magnitude of Residues of IKI-3106 on Pome Fruit - USA and Canada in 2013.
Study date
2013
Data no
245680
Title
R1 Evaluation of NUL3445 Residues in Pears; Australia, 2021.
Study date
2022
Data no
245681
Title
R2 Evaluation of NUL3445 Residues in Macadamia Nuts; Australia, 2020.
Study date
2020
Data no
245682
Title
R3 Evaluation of NUL3445 Residues in Macadamia Nuts; Australia, 2021.
Study date
2021
Data no
245683
Title
R4 Evaluation of NUL3445 Residues in Almonds.
Study date
2022
Data no
245684
Title
R5 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Indoor Sweet Peppers in Northern and Southern Europe in 2012.
Study date
2013
Data no
245685
Title
R6 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Indoor Sweet Peppers in Northern and Southern Europe in 2013.
Study date
2013
Data no
245686
Title
R7 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Indoor Tomatoes in Northern and Southern Europe in 2012.
Study date
2013
Data no
245687
Title
R8 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest, Decline and Processing) with IKI-3106 50SL (IBE 4064) Applied to Indoor Tomatoes in Northern and Southern Europe in 2012.
Study date
2013
Data no
245688
Title
R9 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Indoor Tomatoes in Northern and SOUTHERN Europe in 2013.
Study date
2013
Data no
245689
Title
R10 Evaluation of NUL3445 Residues in Vegetable Brassica.
Study date
2022
Data no
245690
Title
R12 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Broccoli in Northern and Southern Europe in 2012.
Study date
2013
Data no
245691
Title
R13 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Broccoli in Northern and Southern Europe in 2013.
Study date
2013
Data no
245692
Title
R14 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Brussels Sprouts in Northern and Southern Europe in 2012.
Study date
2013
Data no
245693
Title
R15 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Brussels Sprouts in Northern and Southern Europe in 2013.
Study date
2013
Data no
245694
Title
R16 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Brussels Sprouts in Northern and Southern Europe in 2013.
Study date
2014
Data no
245695
Title
R17 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Cauliflowers in Northern and Southern Europe in 2012.
Study date
2013
Data no
245696
Title
R18 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Cauliflowers in Northern and Southern Europe in 2013.
Study date
2013
Data no
245697
Title
R19 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Head Cabbage in Northern and Southern Europe in 2012.
Study date
2013
Data no
245698
Title
R20 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Head Cabbage in Northern and Southern Europe in 2013.
Study date
2013
Data no
245699
Title
R11 Evaluation of NUL3445 Residues in Leafy Vegetables.
Study date
2022
Data no
245700
Title
R21 Magnitude of Residues of IKI-3106 on Lettuce and Spinach - USA and Canada in 2012.
Study date
2014
Data no
245701
Title
R22 Magnitude of Residues of IKI-3106 on Leafy Brassicas - USA and Canada in 2012.
Study date
2014
Data no
245702
Title
R23 IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Kale in Northern Europe in 2013.
Study date
2013
Data no
245764
Title
90896 Magnitude of Residues of IKI-3106 on IKI-3106 50SL (IBE 4064) Residue Study (at Harvest and Decline) with IKI-3106 50SL (IBE 4064) Applied to Apples in Northern and Southern Europe in 2013.
Study date
2013
Data no
251192
Title
IKI-3106 50SL (IBE4064) Crop Rotation Residue Study with IKI-3106 50SL (IBE4064) Applied to Outdoor Tomato and Outdoor Peppers in Northern and Southern Europe in 2012.
Study date
2013
Data no
251193
Title
Field Accumulation of IKI-3106 in Rotational Crop Wheat - USA in 2012.
Study date
2013
Date
Application Date
Application No
Application Number
136980
Product/Active constituent Name
Application Product Name
Terbubest 875WG Herbicide
Application Date
Application Number
136980
Application Product Name
Terbubest 875WG Herbicide
Application details
Product name:
Terbubest 875WG Herbicide
Product number:
92860
Applicant Name:
Hebei Shanli Chemical Company Limited
Application purpose and description of use:
Registration of an 875 g/kg Terbuthylazine water dispersible granule product for the control of weeds in cereals (barley,oats, wheat) chickpeas, faba beans, fallows, field peas, lentils, lupins, sorghum, triazine tolerant canola as
per the directions for use table.
Reference details:
87730 - ACP Terbuthylazine 875 WG Herbicide
88599 - Conquest TerbaQuest 875 WG Selective Herbicide
85533 - Genfarm Terbuthylazine 875 WG Herbicide
84781 - Titan Terbuthylazine 875 WG Herbicide
Active constituents:
Active constituent name
90138 - TERBUTHYLAZINE
Description of data provided:
Data no
244147
Title
Certificate of analysis
Study date
August 2021
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244149
Title
MANUFACTURE PROCESS OF Terbuthylazine 87.5% WG
Study date
August 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244150
Title
Specification of Terbuthylazine 875 WG
Study date
August 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244151
Title
Material Safety Data Sheet
Study date
March 2006
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244152
Title
Safety Data Sheet
Study date
April 2015
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244153
Title
SAFETY DATA SHEET
Study date
February 2016
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244148
Title
Accelerated storage stability test of Terbuthylazine 875 WG
Study date
April 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
250833
Title
RESPONSE: Terbubest 875WG Herbicide (92860/136980)
Study date
March 2023
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
250834
Title
Directions for use
Study date
March 2023
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244154
Title
BIOEQUIVALENCE OF HEBEI TERBUTHYLAZINE 875WG WITH ACP TERBUTHYLAZINE PRE-EMERGENCE WEED CONTROL IN FALLOW PROJECT: Hebei-Terb-Bioeq Fallow-2022-1 INTERIM REPORT OF EXPERIMENT CONDUCTED AT LANGLANDS, QLD
Study date
July 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244155
Title
BIOEQUIVALENCE OF HEBEI TERBUTHYLAZINE 875WG WITH ACP TERBUTHYLAZINE IN TANK MIXES WITH FLUROXPYR FOR POST-EMERGENCE WEED CONTROL IN SORGHUM
Study date
March 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244156
Title
BIOEQUIVALENCE OF HEBEI TERBUTHYLAZINE 875WG WITH ACP TERBUTHYLAZINE PRE-EMERGENCE WEED CONTROL IN FALLOW
Study date
July 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
244157
Title
Argument to supplement efficacy data for Terbubest 875WG Herbicide
Study date
August 2022
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
276827
Title
RESPONSE: Terbubest 875WG Herbicide (92860/136980)
Study date
August 2024
Auth party contact address
F/L 15th, Zhongyue Building No.170, Yucai Street Yuhua District Shijiazhuang City China
Data no
276828
Title
Product: Titan Prothioconazole 480SC Fungicide
Study date
August 2024
Auth party contact address
-
Data no
276829
Title
Product: Titan Aminopyralide 140 + Aminopyralid 10 EC Herbicide
Study date
August 2024
Auth party contact address
-
Data no
276830
Title
Product: Nufarm Crucial Herbicide
Study date
August 2024
Auth party contact address
-
Date
Application Date
Application No
Application Number
136846
Product/Active constituent Name
Application Product Name
velagliflozin
Application Date
Application Number
136846
Application Product Name
velagliflozin
Application details
Product name:
velagliflozin
Product number:
92836
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of a 15 mg/mL velagliflozin oral solution for the treatment of diabetes mellitus in cats, in conjunction with approval of velagliflozin.
Description of data provided:
Data no
243818
Title
Analytical Procedures for the Drug Substance
Study date
9/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243819
Title
Validation of Analytical Procedures for the Drug Substance
Study date
10/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243820
Title
Batch Analysis for the Drug Substance
Study date
14/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243821
Title
Certificate of GMP Compliance of Manufacturer -Velagliflozin L-proline H2O
Study date
7/04/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243822
Title
Description of Manufacturing Process and Process Controls -Velagliflozin L-proline H2O
Study date
9/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243823
Title
Control of Materials -Velagliflozin L-proline H2O
Study date
18/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243824
Title
Manufacturing Process Development -Velagliflozin L-proline H2O
Study date
9/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243825
Title
Control of Critical Steps and Intermediates -Velagliflozin L-proline H2O
Study date
9/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243826
Title
Impurities in the Drug Substance
Study date
18/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243827
Title
Specifications for the Drug Substance
Study date
15/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243828
Title
Justification of the Specifications for the Drug Substance
Study date
18/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243829
Title
Description of the Container Closure System -Velagliflozin L-proline H2O
Study date
8/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243830
Title
Specification for the Container Closure Component active substance
Study date
8/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243831
Title
Nomenclature -Velagliflozin L-proline H2O
Study date
8/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243832
Title
Elucidation of Structure - Velagliflozin L-proline H2O
Study date
11/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243833
Title
General Properties - Velagliflozin L-proline H2O
Study date
8/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243834
Title
Analytical Reference Standard for Drug Product
Study date
13/05/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243835
Title
Stability Summary and Conclusions -Velagliflozin L-proline H2O
Study date
14/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
243836
Title
Stability Data Accelerated and Long-Term Stability Studies for the Drug Substance
Study date
14/03/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271228
Title
MUTAGENICITY IMPURITY ASSESSMENT- VELAGLIFLOZIN.
Study date
28/01/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271220
Title
Acute Oral Toxicity Study in the Mouse with BI 54499 XX L-proline monohydrate - Acute Toxic Class Method.
Study date
6/06/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271221
Title
Acute Oral Toxicity Study of BI 54499 XX L-proline monohydrate in the Rat - Acute Toxic Class Method.
Study date
6/06/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271237
Title
Evaluation of Respiratory Function Following Oral Administration of BI 54499 XX L-Proline Monohydrate in Rats.
Study date
30/05/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271238
Title
Effects of BI 54499 XX (3, 10 and 30 mg/kg p.o.) on renal and liver function in conscious rats.
Study date
19/05/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271239
Title
Effects of BI 54499 XX (3, 10 and 30 mg/kg i.d.) on gastric secretion in rats.
Study date
30/01/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271226
Title
Velagliflozin:? Preliminary Study for Effects on Fertility and Embryo Fetal Development in the Han Wistar Rat by Repeated Once Daily Oral (Gavage) Administration.
Study date
23/12/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271227
Title
Velagliflozin:? Study for Effects on Fertility and Embryo-Fetal Development in the Han Wistar Rat by Repeated Once Daily Oral (Gavage) Administration.
Study date
7/07/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271229
Title
BI 54499: In-vitro inhibition of SGLT2 and selectivity vs human SGLT1 and GLUT1 transporters.
Study date
23/11/2007
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271230
Title
Influence of BI 54499 XX on hERG-mediated potassium current in HEK293 cells and on action potential configuration in isolated guinea pig papillary muscle.
Study date
20/12/2007
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271231
Title
nfluence of BI 54499 (1, 3 and 10 mg/kg PO) on hemodynamic and electrocardiographic parameters in conscious dogs.
Study date
13/02/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271232
Title
BI 54499 XX L-Proline Monohydrate: Cardiovascular Evaluation in Conscious Telemetered Dogs.
Study date
3/07/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271233
Title
Effects of BI 54499 XX (3, 10 and 30 mg/kg p.o.) on gastric emptying and intestinal transit in rats.
Study date
29/04/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271234
Title
Neuropharmacological Profile (NPP) of BI 54499 XX L-Proline Monohydrate in Rats.
Study date
29/05/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271235
Title
Effects of BI 54499 XX on behaviour assessed by observation in a modified IRWIN-test and on nocturnal activity in mice after oral administration of 3, 10 and 30 mg/kg.
Study date
17/04/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271236
Title
Effects of oral administration of BI 54499 XX in doses of 3, 10 and 30 mg/kg on vital physiological functions in conscious rats using a telemetry / plethysmography system
Study date
7/05/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271217
Title
Pharmacokinetics of BI 54499 Administered as BI 54499 XX L-Proline Monhydrate to Wistar Rats.
Study date
13/03/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271218
Title
Pharmacokinetics of the BI 54499 XX L-Proline Monohydrate after Intravenous and Oral Dosing in Male Beagle Dogs (BIPI Study No. PK-07-1016).
Study date
4/02/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271219
Title
14C-BI 54499 LPM In Vitro Blood Cell Partitioning Study in Rat, Dog, and Human Blood.
Study date
28/08/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271222
Title
A 2 Week Oral Gavage Toxicity and Toxicokinetic Study in the CD- 1 Mouse with BI 54499 XX L-proline monohydrate.
Study date
2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271223
Title
A 1-Week Oral (Gasric Intubation) Maximum Tolerated Dose Study in the Rat with BI 54499 (proline co-crystal).
Study date
2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271224
Title
A 4-Week Oral Gavage Toxicity Study in the Wistar Rat with BI 54499 XX L-proline monohydrate followed by a 4-Week Recovery Period.
Study date
2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271225
Title
A 4-Week Toxicity Study of BI 54499 XX L-Proline Administered by Oral Gavage to Dogs with an 8-Week Recovery Period.
Study date
13/10/2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia