Application Summaries

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 browse function and links below to find and view application summaries.

APIGUARD GEL FOR BEEHIVES

Application Date

04-Oct-2023

Application Number

141520

Application Details

Product name

APIGUARD GEL FOR BEEHIVES

Product no

65570

Applicant name

VITA (EUROPE) LIMITED

Application purpose and description of use

Variation of product registration and label approval.

Description of data provided

Data no
259473
Author
NSW DPI
Title
DPI website - Varroa mite emergency response - 22-SEP-23
Study date
2023
Publication
N/A
Authorising party
Public
Auth party contact address
-
Data no
259474
Author
NSW DPI
Title
2023-09-20 - New Emergency Order
Study date
2023
Publication
N/A
Authorising party
Public
Auth party contact address
-

Azoxystrobin

Application Date

03-Oct-2023

Application Number

141453

Application Details

Product name

Azoxystrobin

Active name

Azoxystrobin

Applicant name

AGOCEANIA PTY LTD

Application purpose and description of use

Approval of Azoxystrobin for use in agricultural chemical products.

Description of data provided

Data no
259336
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Manufacture Process of Azoxystrobin Technical
Study date
July 5, 2023
Publication
No
Authorising party
Applicant
Data no
259339
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
The Justification of Impurities of Azoxystrobin Technical
Study date
July 5, 2023
Publication
No
Authorising party
Applicant
Data no
259334
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Five Batches Analysis of Azoxystrobin TC
Study date
January 11, 2016
Publication
No
Authorising party
Applicant
Data no
259340
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
The statement of batch size of Azoxystrobin technical in 5-batch report
Study date
July 5, 2023
Publication
No
Authorising party
Applicant
Data no
259337
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Physical and chemical properties of Azoxystrobin
Study date
July 5, 2023
Publication
No
Authorising party
Applicant
Data no
259338
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Registration Data of Azoxystrobin
Study date
July 5, 2023
Publication
No
Authorising party
Applicant
Data no
259335
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
DoC of Azoxystrobin TC
Study date
July 5, 2023
Publication
No
Authorising party
Applicant

Farmozine 900 Herbicide

Application Date

03-Oct-2023

Application Number

141478

Application Details

Product name

Farmozine 900 Herbicide

Product no

93852

Applicant name

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product registration and label approval to add an additional pack size and update the directions for use.

Active constituents

Active constituent name

44367 - ATRAZINE

Description of data provided

Data no
259408
Author
Gengos, M.
Title
Executive Summary
Study date
25 September 2023
Publication
-
Authorising party
Applicant

Reference Details

46810 - FARMOZINE 900 WG HERBICIDE
49552 - GESAPRIM GRANULES 900 WG HERBICIDE
64206 - ENFORCER 75-D HERBICIDE
92617 - GESAPRIM 900WG Herbicide

TICKPRO DUO TICK DEVELOPMENT INHIBITOR AND BROAD SPECTRUM POUR-ON

Application Date

03-Oct-2023

Application Number

141476

Application Details

Product name

TICKPRO DUO TICK DEVELOPMENT INHIBITOR AND BROAD SPECTRUM POUR-ON

Product no

90905

Applicant name

SPECIALIST SALES PTY LTD

Application purpose and description of use

Variation of product registration and label approval to vary relevant particulars.

Active constituents

Active constituent name

82733 - IVERMECTIN

Active constituent name

82732 - FLUAZURON

Campbell Wrath 700WG Fungicide

Application Date

03-Oct-2023

Application Number

141477

Application Details

Product name

Campbell Wrath 700WG Fungicide

Product no

82661

Applicant name

COLIN CAMPBELL (CHEMICALS) PTY LTD

Application purpose and description of use

Variation of label approval to reduce the rate of use for control of downy mildew on grapevines.

Active constituents

Active constituent name

69308 - DITHIANON

Active constituent name

88181 - Dithianon

Reference Details

80823 - DINON 700 WG FUNGICIDE

MAXICAM ANTI-INFLAMMATORY INJECTABLE FOR DOGS AND CATS

Application Date

29-Sep-2023

Application Number

141463

Application Details

Product name

MAXICAM ANTI-INFLAMMATORY INJECTABLE FOR DOGS AND CATS

Product no

92420

Applicant name

VETPHARM LABORATORIES IP PTY LTD

Application purpose and description of use

Variation of product registration and/or label approval to vary pack sizes.

Active constituents

Active constituent name

84110 - Meloxicam

Gastrosyl Bismuth salicylate oral suspension

Application Date

29-Sep-2023

Application Number

141034

Application Details

Product name

Gastrosyl Bismuth salicylate oral suspension

Product no

93950

Applicant name

VETSENSE PTY LTD

Application purpose and description of use

Registration of a Bismuth Salicylate 17.5 mg/mL oral suspension, to be used as an aid in the treatment of gastroenteritis and diarrhoea in horses and dogs.

Description of data provided

Data no
258440
Author
Not identified
Title
Quality Control
Study date
2022
Publication
-
Authorising party
Applicant
Data no
258441
Author
Not identified
Title
Finish Product Specifications
Study date
23 December 2021
Publication
-
Authorising party
Applicant
Data no
258439
Author
Not identified
Title
Manufacturing
Study date
2023
Publication
-
Authorising party
Applicant

Reference Details

39578 - PEPTOSYL BISMUTH SALICYLATE ORAL SUSPENSION

Glysmart 600 Herbicide

Application Date

29-Sep-2023

Application Number

141213

Application Details

Product name

Glysmart 600 Herbicide

Product no

94011

Applicant name

GROW CHOICE PTY LTD

Application purpose and description of use

Registration of a 600 g/L formulation of glyphosate (as the potassium salt) - A non-selective herbicide for the control of many annual and perennial weeds

Active constituents

Active constituent name

63383 - GLYPHOSATE

Active constituent name

64304 - GLYPHOSATE

Description of data provided

Data no
258460
Author
Andrew Somervaille
Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW GLYSMART600-BIOEQ- 2023-02
Study date
16 May 2023
Publication
-
Authorising party
Applicant
Data no
258454
Author
anon
Title
C of A for active
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
258457
Author
anon
Title
Executive Summary
Study date
25 August 2023
Publication
-
Authorising party
Applicant
Data no
258466
Author
Andrew Sommervaille
Title
EVALUATION OF A K SALT FORMULATION OF GLYPHOSATE ALONE AND IN COMBINATION WITH VARIOUS SURFACTANTS FOR WEED CONTROL IN FALLOW GC-GC-GLY600-FALLOW-2022-01-02
Study date
6 May 2023
Publication
-
Authorising party
Applicant
Data no
258463
Author
Andrew Sommervaille
Title
BIOEQUIVALENCE OF GLYSMART 600 +/- TERWETT 3780 AND GLYSOWET FOR FALLOW WEED CONTROL 14 May 2023 GLYSMART600-BIOEQ-TERWETT-2023_01
Study date
14 May 2023
Publication
-
Authorising party
Applicant
Data no
258455
Author
anon
Title
Safety Data Sheets
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
258467
Author
Andrew Sommervaille
Title
BIOEQUIVALENCE OF GROW CHOICE GLYPHOSATE 600K, GLYSMART 600 AND ROUNDUP CT FOR PRE-HARVEST DRYDOWN OF GRAIN SORGHUM GC-GC-GLY600-SORG-PREHARV-2022-01-01
Study date
6 May 2023
Publication
-
Authorising party
Applicant
Data no
258458
Author
anon
Title
Part 8 - Efficacy
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258464
Author
Andrew Sommervaille
Title
EVALUATION OF A K SALT FORMULATION OF GLYPHOSATE ALONE AND IN COMBINATION WITH VARIOUS SURFACTANTS FOR WEED CONTROL IN FALLOW GC-GC-GLY600-FALLOW-2022-01-03
Study date
6 May 2023
Publication
-
Authorising party
Applicant
Data no
258461
Author
Andrew Sommervaille
Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW GLYSMART600-BIOEQ- 2023-03
Study date
17 May 2023
Publication
-
Authorising party
Applicant
Data no
258465
Author
Andrew Sommervaille
Title
EVALUATION OF A K SALT FORMULATION OF GLYPHOSATE ALONE AND IN COMBINATION WITH VARIOUS SURFACTANTS FOR WEED CONTROL IN FALLOW GC-GC-GLY600-FALLOW-2022-01-01
Study date
6 May 2023
Publication
-
Authorising party
Applicant
Data no
258462
Author
Andrew Sommervaille
Title
BIOEQUIVALENCE OF GLYSMART 600 +/- TERWET 3780 AND GLYSOWET FOR FALLOW WEED CONTROL GLYSMART600-BIOEQ-TERWETT-2023_2
Study date
14 May 2023
Publication
-
Authorising party
Applicant
Data no
258456
Author
J. Scopec
Title
Determination of the Physical-chemical properties of Glyphosate 600 SL formulation
Study date
25 May 2023
Publication
-
Authorising party
Applicant
Data no
258459
Author
A. Somervaille
Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW Report No: GLYSMART600-BIOEQ- 2023-01
Study date
15 May 2023
Publication
-
Authorising party
Applicant
Data no
258453
Author
anon
Title
Part 2 - Chemistry and Manufacture
Study date
August 2023
Publication
-
Authorising party
Applicant

Reference Details

82715 - Glymount 540K Herbicide

Kenso Agcare RAMPAGE EW Insecticide/Miticide

Application Date

29-Sep-2023

Application Number

141256

Application Details

Product name

Kenso Agcare RAMPAGE EW Insecticide/Miticide

Product no

94021

Applicant name

KENSO CORPORATION (M) SDN. BHD.

Application purpose and description of use

Registration of a Chlorpyrifos 400 g/L and Bifenthrin 20 g/L EW product for the control of certain insect pests of broadacre crops, cotton and other various crops as specified in the Directions for Use table.

Active constituents

Active constituent name

67331 - CHLORPYRIFOS

Active constituent name

59942 - BIFENTHRIN

Description of data provided

Data no
258772
Author
Kenso Corporation (M) Sdn Bhd
Title
Part 2 Chemistry and Manufacture dossier of RAMPAGE EW
Study date
28/8/2023
Publication
-
Authorising party
Applicant
Data no
258778
Author
M. Sargean
Title
Appendix 8.1 The efficacy of insecticides at controlling red legged earth mites in canola
Study date
Sep 2017
Publication
-
Authorising party
Applicant
Data no
258775
Author
Kenso Corporation (M) Sdn Bhd
Title
2 3 Stability Report of Kenso Agcare RAMPAGE EW Insecticide/Miticide
Study date
20/11/2022
Publication
-
Authorising party
Applicant
Data no
258776
Author
Kenso Corporation (M) Sdn Bhd
Title
2 4 Analytical Method of Rampage EW by GC
Study date
24/11/2022
Publication
-
Authorising party
Applicant
Data no
258779
Author
M. Sargeant
Title
Appendix 8.2 The efficacy of a range of insecticides at controlling red legged earth mites in wheat
Study date
Sep 2017
Publication
-
Authorising party
Applicant
Data no
258773
Author
Kenso Corporation (M) Sdn Bhd
Title
2 1 Certificate of Analysis of Active Constituents
Study date
2022
Publication
-
Authorising party
Applicant
Data no
258774
Author
Kenso Corporation (M) Sdn Bhd
Title
2 2 SDS of Inert Ingredients
Study date
28/8/2023
Publication
-
Authorising party
Applicant
Data no
258777
Author
Kenso Corporation (M) Sdn Bhd
Title
Part 8 Efficacy and Crop Safety of RAMPAGE EW
Study date
28/8/2023
Publication
-
Authorising party
Applicant

Reference Details

68781 - PYRINEX SUPER INSECTICIDE / MITICIDE

Surefire Chlorantraniliprole 350 WG Insecticide

Application Date

29-Sep-2023

Application Number

141288

Application Details

Product name

Surefire Chlorantraniliprole 350 WG Insecticide

Product no

88598

Applicant name

PCT HOLDINGS PTY LTD

Application purpose and description of use

Variation of product registration and label approval to add use for control of carob moth in almond crops.  

Active constituents

Active constituent name

86178 - CHLORANTRANILIPROLE

Description of data provided

Data no
258543
Author
R Murray
Title
Part 8 Summary
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
258541
Author
S Harvey
Title
Evaluation of PCT International Surefire Chlorantraniliprole for the control Carob Moth (Ectomyelois ceratoniae) in Almonds.
Study date
23/06/2022
Publication
-
Authorising party
Applicant
Data no
258542
Author
FMC Australasia Pty Ltd
Title
Altacor Hort Insecticide 69957/109980
Study date
14/08/2018
Publication
-
Authorising party
Public
Auth party contact address
-

bismuth subsalicylate

Application Date

29-Sep-2023

Application Number

141313

Application Details

Product name

bismuth subsalicylate

Active name

bismuth subsalicylate

Applicant name

VETSENSE PTY LTD

Application purpose and description of use

New source of pharmacopoeia active constituent.

Description of data provided

Data no
258719
Author
Not identified
Title
CoA - API
Study date
2021
Publication
-
Authorising party
Applicant

IMTRADE SENTINEL 800 VERIPHY SL INSECTICIDE

Application Date

29-Sep-2023

Application Number

141452

Application Details

Product name

IMTRADE SENTINEL 800 VERIPHY SL INSECTICIDE

Product no

94076

Applicant name

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use

Registration of a 800g/L OMETHOATE soluble liquid product for the control of certain pests on Ornamentals as specified in the Directions for Use table.

Active constituents

Active constituent name

59132 - OMETHOATE

Description of data provided

Data no
259333
Author
N/A
Title
Imtrade Sentinel 800 VeripHy SL Insecticide Formulation & Supporting Info
Study date
20/09/2023
Publication
-
Authorising party
Applicant

Reference Details

59872 - CHEMAG SENTINEL 800 INSECTICIDE SPRAY

Sugar beet

Application Date

28-Sep-2023

Application Number

141351

Application Details

Product name

Sugar beet

Product no

94051

Applicant name

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use

Registration of a 900 g/L Beet Extract product that is a natural elicitor that enhances the plant defences in Vine grapes increasing their resistance to Botrytis infection in conjunction with approval of Beet Extract active constituent..

Description of data provided

Data no
259227
Author
Kulbach, B.
Title
Analysis report 23003358-01-1 beet extract. Acylamide and hydroxymethylfurfural. Report no. 23003358-01-1
Study date
17 July 2023.
Publication
-
Authorising party
Applicant
Data no
259204
Author
Babuder, M
Title
Sample overview: Sugar beet extract (raw ingredient). Waikaitu Ltd., Tasman, New Zealand, 16 February 2022
Study date
16 February 2022
Publication
-
Authorising party
Applicant
Data no
259210
Author
Ferguson, L
Title
Certificate of Analysis. Cawthron Analytical Science, Nelson, New Zealand; report no. 941026
Study date
2 May 2022
Publication
-
Authorising party
Applicant
Data no
259218
Author
Bacher, R.
Title
Two batch analysis of trimethylglycine in beet extract samples. Report no. S22- 06525, ADAMA file report 000111862
Study date
16 September 2022.
Publication
-
Authorising party
Applicant
Data no
259230
Author
Anon.
Title
ADS-43. Document M-CP, Section 5. Analytical Methods.
Study date
July 2023.
Publication
-
Authorising party
Applicant
Data no
259207
Author
Anon
Title
Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and feed supplements. Scientific Report 2663,
Study date
2012
Publication
EFSA Journal 2012;10(5)
Authorising party
Public
Auth party contact address
-
Data no
259201
Author
Spickermann, G.
Title
QSAR estimation of vapour pressure, partition coefficient, and Henry??s law constant by using the EPISuite model version 4.11.
Study date
11 August 2022
Publication
-
Authorising party
Applicant
Data no
259224
Author
Kulbach, B.
Title
Analysis report 22006105-02-1 beet extract. Tropane alkaloids. Report no. 22006105-01-2
Study date
7 November 2022.
Publication
-
Authorising party
Applicant
Data no
259221
Author
Anon.
Title
Certificate of Accreditation. Cawthron Institute, Accreditation no. 107, 12 May 2022
Study date
12 May 2022
Publication
-
Authorising party
Applicant
Data no
259198
Author
Andrews, C.
Title
Determination Of Active Content & Physical Characteristics of Beet Extract in HDPE Containers Following Accelerated Storage For Two Weeks At 54 ??C. Report No. S22-0328.
Study date
21 March 2023.
Publication
-
Authorising party
Applicant
Data no
259202
Author
Anon.
Title
Consensus document on compositional considerations for new varieties of sugar beet: Key food and feed nutrients and antinutrients. Series on the Safety of Novel Foods and Feeds, No. 3 OECD Environmental Directorate,
Study date
2002
Publication
ENV/JM/MONO(2002)4
Authorising party
Public
Auth party contact address
-
Data no
259225
Author
Kulbach, B.
Title
Analysis report 22006106-03-1 beet extract. Hydroxymethylfurfural HMF. Report no. 22006106-03-1
Study date
15 November 2022.
Publication
-
Authorising party
Applicant
Data no
259216
Author
Harris, K. Lewis, D & Chomphoosri, P
Title
Certificate of Analysis. Amended. Cawthron Analytical Science, Nelson
Study date
7 July 2023.
Publication
-
Authorising party
Applicant
Data no
259222
Author
DAkkS
Title
Akkreditierung Deutsche Akkreditierungsstelle GmbH. Institut Kurz GmbH. Certificate no. D-PL-14140-01-00
Study date
14 December 2021
Publication
-
Authorising party
Applicant
Data no
259199
Author
Yalkowsky, S. H, He, H. and Jain, P.
Title
HANDBOOK OF Aqueous Solubility Data. SECOND EDITION. 2010 CEC Pres Taylor & Francis Group.
Study date
2010
Publication
HANDBOOK OF Aqueous Solubility Data. SECOND EDITION. 2010 CEC Pres Taylor & Francis Group.
Authorising party
Public
Auth party contact address
-
Data no
259205
Author
Babuder, M.
Title
Sample overview part 2: Sugar beet extract (raw ingredient) Waikaitu Ltd., Tasman, New Zealand,
Study date
19 December 2022
Publication
-
Authorising party
Applicant
Data no
259213
Author
Harris, K., Brownlow, A
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 938445
Study date
27 April 2022.
Publication
-
Authorising party
Applicant
Data no
259219
Author
Bacher, R.
Title
Analysis of trimethylglycine in two batches of beet extract. Report no. S23- 101874, ADAMA file report 00011
Study date
30 May 2023.
Publication
-
Authorising party
Applicant
Data no
259208
Author
Kaur, N.
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 921895
Study date
12 January 2022
Publication
-
Authorising party
Applicant
Data no
259214
Author
Kaur, N.
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 976076
Study date
21 December 2021.
Publication
-
Authorising party
Applicant
Data no
259220
Author
Kulbach, B
Title
Analysis report 22006103-02-1 beet extract. Chemical results free amino acids. Report no. 22006103-02
Study date
2 November 2022.
Publication
-
Authorising party
Applicant
Data no
259228
Author
Bacher, R.
Title
Analysis of the Composition Fingerprint of Four Batches of Beet Extract. Report No. S23-104968
Study date
27 July 2023
Publication
-
Authorising party
Applicant
Data no
259211
Author
Harries, K., Lewis, D., Chomphoosri, P
Title
Certificate of Analysis. Cawthron Analytical Science, Nelson, New Zealand; report no. 864603
Study date
26 Jan 2021
Publication
-
Authorising party
Applicant
Data no
259217
Author
Bacher, R.
Title
Method validation and batch analysis of trimethylglycine in beet extract and ADS-43 formulated product samples. report no. S21- 09099, ADAMA file report 000109781
Study date
12 May 2022
Publication
-
Authorising party
Applicant
Data no
259200
Author
Liang, H.
Title
Dioxins and furans content in 1` batch of beet extract. Report No. AR-22-NC-009555-01.
Study date
27 April 2022.
Publication
-
Authorising party
Applicant
Data no
259229
Author
Ferguson, L.
Title
Methodology information. Amended letter. Report no. 1426B
Study date
26 June 2023
Publication
-
Authorising party
Applicant
Data no
259206
Author
JSC Inspectorate R
Title
Non-GMO Certificate R141703 Results of inspection.
Study date
28 August 2017
Publication
-
Authorising party
Applicant
Data no
259212
Author
Babuder, M.
Title
Statement on internal and external molasses labelling. Identification BT210122.
Study date
6 March 2022
Publication
-
Authorising party
Applicant
Data no
259203
Author
Todd, M., Patel, S., Kramer, R., Prikhodko, D., Rylko, D. Serova, E. and
Title
Russian Federation. Sugar sector review. FAO Investment Centre, Rome 2013
Study date
2013
Publication
Food and agriculture organization oF the united nations rome, 2013
Authorising party
Public
Auth party contact address
-
Data no
259226
Author
Kulbach, B.
Title
Analysis Pyrrolizidine Tropane alkaloids. Report 23003358-02-2
Study date
29 July 2023.
Publication
-
Authorising party
Applicant
Data no
259209
Author
Babuder, M
Title
Analysis of sugar beet molasses. Statement identification number GB201016-19
Study date
20 April 2022
Publication
-
Authorising party
Applicant
Data no
259215
Author
Harris, K. Lewis, D & Chomphoosri, P
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 989894
Study date
30 March 2023
Publication
-
Authorising party
Applicant
Data no
259223
Author
Kulbach, B.
Title
Analysis report 22006104-02-1 beet extract. Pyrrolizidine alkaloids. report no. 22006104-01-2
Study date
7 November 2022.
Publication
-
Authorising party
Applicant

Nufarm Weedmaster DUO Herbicide

Application Date

28-Sep-2023

Application Number

141445

Application Details

Product name

Nufarm Weedmaster DUO Herbicide

Product no

53576

Applicant name

NUFARM AUSTRALIA LIMITED

Application purpose and description of use

Variation of product registration and label approval to allow marker dyes to be used and various minor label updates.

Active constituents

Active constituent name

44453 - GLYPHOSATE

Active constituent name

55368 - GLYPHOSATE

Active constituent name

55695 - GLYPHOSATE

Active constituent name

44279 - GLYPHOSATE

Active constituent name

56452 - GLYPHOSATE

Active constituent name

44042 - GLYPHOSATE

Active constituent name

44040 - GLYPHOSATE

Active constituent name

44041 - GLYPHOSATE

Description of data provided

Data no
259344
Author
Nufarm
Title
Draft Label - Marked Up
Study date
Sep 2023
Publication
-
Authorising party
Applicant
Data no
259345
Author
Nufarm
Title
Draft Label - Clean
Study date
Sep 2023
Publication
-
Authorising party
Applicant
Data no
259343
Author
K Lock
Title
Executive Summary
Study date
Sep 2023
Publication
-
Authorising party
Applicant

Azoxystrobin Technical

Application Date

28-Sep-2023

Application Number

141454

Application Details

Product name

Azoxystrobin Technical

Active name

Azoxystrobin Technical

Applicant name

HEMANI AUSTRALIA PTY LTD

Application purpose and description of use

Approval of Azoxystrobin for use in agricultural chemical products.

Description of data provided

Data no
259367
Author
Hemani Industries Ltd, India
Title
Azoxystrobin AC Part 2 Chemistry and Manufacture - Hemani, India
Study date
15.09.2023
Publication
-
Authorising party
Applicant
Data no
259370
Author
Ganesh Mhatre
Title
Appendix 2.3 - Azoxystrobin TC-Batch Size Details
Study date
15.09.2023
Publication
-
Authorising party
Applicant
Data no
259371
Author
Anil V.
Title
Appendix 2.4 - GLP 5 batch _AG-G0668_FR
Study date
03.03.2023
Publication
-
Authorising party
Applicant
Data no
259368
Author
Ganesh Mhatre
Title
Appendix 2.1 Manufacuring Process Azoxystronin Technical, Hemani, India
Study date
15.09.2023
Publication
-
Authorising party
Applicant
Data no
259369
Author
Ganesh Mhatre
Title
Appendix 2.2 - DECLARATION_OF_COMPOSITION_-_Azoxystrobin TC__Hemani
Study date
15.09.2023
Publication
-
Authorising party
Applicant

Chlorfenapyr Technical

Application Date

28-Sep-2023

Application Number

141455

Application Details

Product name

Chlorfenapyr Technical

Active name

Chlorfenapyr Technical

Applicant name

Shandong Rainbow International Co Ltd

Application purpose and description of use

Approval of Chlorfenapyr Technical Technical for use in agricultural chemical products.

Description of data provided

Data no
259350
Author
Dave Pomeroy
Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice -Part 3
Study date
20/07/2020
Publication
-
Authorising party
Applicant
Data no
259347
Author
Dave Pomeroy
Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice.- Part 1
Study date
20/07/2020
Publication
-
Authorising party
Applicant
Data no
259353
Author
anon
Title
DOC
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259348
Author
Dave Pomeroy
Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice -Part 2
Study date
20/07/2020
Publication
-
Authorising party
Applicant
Data no
259351
Author
Anon
Title
MANUFACTURE PROCESS OF CHLORFENAPYR TECHNICAL
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259346
Author
Yasser Sokeirik
Title
Chemistry &Manufacturing Dossier
Study date
18/07/2023
Publication
-
Authorising party
Applicant
Data no
259354
Author
Anon
Title
The Statement of Batch Size of Propamocarb CHLORFENAPYR TECHNICAL in 5-Batch Report
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259352
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF CHLORFENAPYR TECHNICAL
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259349
Author
Dave Pomeroy
Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice -Part 3
Study date
20/07/2020
Publication
-
Authorising party
Applicant
Data no
259355
Author
Anon
Title
-
Study date
2023
Publication
-
Authorising party
Applicant

NexGard Spectra Chewables for Dogs 2 - 3.5 kg

Application Date

28-Sep-2023

Application Number

141437

Application Details

Product name

NexGard Spectra Chewables for Dogs 2 - 3.5 kg

Product no

81008

Applicant name

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use

Variation of product label approval to lower the minimum bodyweight of dogs treated with this product.

Active constituents

Active constituent name

82206 - Milbemycin oxime

Active constituent name

81625 - AFOXOLANER

Description of data provided

Data no
259187
Author
Boehringer Ingelheim Animal Health
Title
PRD 0230701 - Target Animal Safety Study
Study date
2011
Publication
-
Authorising party
Applicant
Data no
259184
Author
Boehringer Ingelheim Animal Health
Title
Appendix 1 - PRD 0251101
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259190
Author
Boehringer Ingelheim Animal Health
Title
PRD 0355201 - Target Animal Safety Study
Study date
2022
Publication
-
Authorising party
Applicant
Data no
259193
Author
Kwei et al
Title
Disposition of Ivermectin and Cyclosporin A in CF-1 Mice Deficient in MDR1A P-Glycoprotein
Study date
1999
Publication
-
Authorising party
Public
Auth party contact address
-
Data no
259185
Author
Boehringer Ingelheim Animal Health
Title
PRD 0234001 - Target Animal Safety Study
Study date
2012
Publication
-
Authorising party
Applicant
Data no
259182
Author
Boehringer Ingelheim Animal Health
Title
Executive Summary
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259196
Author
Drag et al.
Title
Safety of Oral Afoxolaner Formulated with or without Milbemycin Oxime in Homozygous MDR1-Deficient Collie Dogs
Study date
2022
Publication
-
Authorising party
Public
Auth party contact address
-
Data no
259197
Author
EMA-CVMP
Title
EMA CVMP Positive Opinion and Assessment Report
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259191
Author
Boehringer Ingelheim Animal Health
Title
Appendix 4 - PRD 0355201
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259194
Author
K Mealey
Title
Canine ABCB1 and Macrocyclic Lactones: Heartworm Prevention and Pharmacogenetics
Study date
2008
Publication
-
Authorising party
Public
Auth party contact address
-
Data no
259188
Author
Boehringer Ingelheim Animal Health
Title
Appendix 3 - PRD 0230701
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259183
Author
Boehringer Ingelheim Animal Health
Title
PRD 0251101 - Target Animal Safety Study
Study date
2013
Publication
-
Authorising party
Applicant
Data no
259195
Author
Tranquilli et al.
Title
Assessment of Toxicosis Induced by High-Dose Administration of Milbemycin Oxime in Collies
Study date
1991
Publication
-
Authorising party
Public
Auth party contact address
-
Data no
259189
Author
Boehringer Ingelheim Animal Health
Title
PRD 0215801 - Target Animal Safety Study
Study date
2010
Publication
-
Authorising party
Applicant
Data no
259186
Author
Boehringer Ingelheim Animal Health
Title
Appendix 2 - PRD 0234001
Study date
2023
Publication
-
Authorising party
Applicant
Data no
259192
Author
Elanco US Inc
Title
Interceptor Plus Product Label
Study date
2023
Publication
-
Authorising party
Public
Auth party contact address
-

CropSure Prozide 500SC Herbicide

Application Date

28-Sep-2023

Application Number

141444

Application Details

Product name

CropSure Prozide 500SC Herbicide

Product no

90212

Applicant name

CROPSURE PTY LTD

Application purpose and description of use

Variation of label approval to match Rustler Selective Herbicide (61360) and F.S.A. Propyzamide 500 SC Herbicide (87920) labels to include Pulse and Canola crops.

Active constituents

Active constituent name

65202 - PROPYZAMIDE

Description of data provided

Data no
259311
Author
Anon
Title
Scientific Argument
Study date
August 2023
Publication
-
Authorising party
Applicant

Reference Details

61360 - RUSTLER SELECTIVE HERBICIDE
87920 - F.S.A. Propyzamide 500 SC Herbicide

Conquest Pinoxaden 100 EC Herbicide

Application Date

27-Sep-2023

Application Number

141430

Application Details

Product name

Conquest Pinoxaden 100 EC Herbicide

Applicant name

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use

Registration of a 100 g/L PINOXADEN and 25 g/L CLOQUINTOCET-MEXYL emulsifiable concentrate (EC) product for
the control of key grass weeds and selective spray topping of Wild Oats in Wheat and Barley

Conquest Hatchet Extra Herbicide EC

Application Date

27-Sep-2023

Application Number

141432

Application Details

Product name

Conquest Hatchet Extra Herbicide EC

Applicant name

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use

Registration of a 8 g/L Aminopyralid and 100 g/L Picloram and 300 g/L Triclopyr for control of a range of environmental and noxious woody and herbaceous weeds as specified in the Directions for Use table.

ANTAGONIST PRO RESIDUAL INSECTICIDE

Application Date

27-Sep-2023

Application Number

141439

Application Details

Product name

ANTAGONIST PRO RESIDUAL INSECTICIDE

Product no

67858

Applicant name

SUNDEW SOLUTIONS PTY LTD

Application purpose and description of use

Variation of label approval to extend the list of situations for control of some ants. To extend pack size range.

Description of data provided

Data no
259253
Author
M Gaven
Title
Reason for application
Study date
19 September 2023
Publication
-
Authorising party
Applicant
Data no
259252
Author
T Priddy
Title
67858 AA letter
Study date
19 September 2023
Publication
-
Authorising party
Applicant

Reference Details

67858 - ANTAGONIST PRO RESIDUAL ANT INSECTICIDE
67858 - ANTAGONIST PRO RESIDUAL INSECTICIDE

TIAMULABS TIAMULIN SOLUBLE POWDER

Application Date

27-Sep-2023

Application Number

141416

Application Details

Product name

TIAMULABS TIAMULIN SOLUBLE POWDER

Product no

68980

Applicant name

ABBEY LABORATORIES PTY LTD

Application purpose and description of use

Variation of product label approval to align the label with the current Vet Labelling Code

Active constituents

Active constituent name

82709 - TIAMULIN HYDROGEN FUMARATE

Active constituent name

84120 - TIAMULIN HYDROGEN FUMARATE

ABBEYMOX FG FEED GRADE AMOXYCILLIN SOLUBLE POWDER

Application Date

26-Sep-2023

Application Number

141148

Application Details

Product name

ABBEYMOX FG FEED GRADE AMOXYCILLIN SOLUBLE POWDER

Product no

68888

Applicant name

ABBEY LABORATORIES PTY LTD

Application purpose and description of use

Variation of product label approval to align the label with the current Vet Labelling Code.

Active constituents

Active constituent name

67784 - ABBEYMOX AMOXYCILLIN SOLUBLE POWDER

Active constituent name

82926 - AMOXYCILLIN TRIHYDRATE

Active constituent name

84057 - AMOXICILLIN TRIHYDRATE

Active constituent name

84262 - AMOXICILLIN TRIHYDRATE

Nufarm EvenBloom Plant Growth Regulator

Application Date

26-Sep-2023

Application Number

141363

Application Details

Product name

Nufarm EvenBloom Plant Growth Regulator

Product no

94056

Applicant name

NUFARM AUSTRALIA LIMITED

Application purpose and description of use

Registration of a 530 g/L Cyanamide (Soluble Concentrate) product for the regulation of bud break in a range of crops.

Active constituents

Active constituent name

63406 - CYANAMIDE

Reference Details

59486 - CYAN PLANT GROWTH REGULATOR

Glyphosate-isopropylammonium Manufacturing Concentrate

Application Date

26-Sep-2023

Application Number

141400

Application Details

Product name

Glyphosate-isopropylammonium Manufacturing Concentrate

Active name

Glyphosate-isopropylammonium Manufacturing Concentrate

Applicant name

Hubei Trisun Chemicals Co, Ltd

Application purpose and description of use

Approval of Glyphosate-isopropylammonium Manufacturing Concentrate for use in agricultural chemical products.

Description of data provided

Data no
259236
Author
Anon
Title
Glyphosate-isopropylammonium Manufacturing Concentrate
Study date
14 September 2023
Publication
Not Published
Authorising party
Applicant
Data no
259233
Author
Tian Yi Qun
Title
Formation Of Impurities Glyphosate IPA Salt 62% Technical Grade
Study date
3 August 2023
Publication
Not Published
Authorising party
Applicant
Data no
259231
Author
Anon
Title
Executive Summary
Study date
August 2023
Publication
Not Published
Authorising party
Applicant
Data no
259234
Author
Tian Yi Qun
Title
Declaration Of Composition
Study date
31 July 2023
Publication
Not Published
Authorising party
Applicant
Data no
259232
Author
Tian Yi Qun
Title
The Formulation Process For Glyphosate IPA Technical
Study date
6 June 2023
Publication
Not Published
Authorising party
Applicant
Data no
259235
Author
Ling Fu
Title
Preliminary Analysis and Enforcement Analytical Method of Glyphosate IPA Salt 62% W/W ??? Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities, and Subsequent 5-Batch Analysis of Glyphosate IPA Salt 62% W/W
Study date
9 November 2021
Publication
Not Published
Authorising party
Applicant

BRAVECTO 1000 MG FLURALANER SPOT-ON SOLUTION FOR LARGE DOGS

Application Date

26-Sep-2023

Application Number

141419

Application Details

Product name

BRAVECTO 1000 MG FLURALANER SPOT-ON SOLUTION FOR LARGE DOGS

Product no

82794

Applicant name

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product label approval.

Active constituents

Active constituent name

80697 - FLURALANER

Description of data provided

Data no
259007
Author
MSD Animal Health
Title
Notification Letter
Study date
June 2023
Publication
-
Authorising party
Applicant

BRAVECTO 1400 MG FLURALANER SPOT-ON SOLUTION FOR VERY LARGE DOGS

Application Date

26-Sep-2023

Application Number

141420

Application Details

Product name

BRAVECTO 1400 MG FLURALANER SPOT-ON SOLUTION FOR VERY LARGE DOGS

Product no

82795

Applicant name

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product label approval.

Active constituents

Active constituent name

80697 - FLURALANER

Description of data provided

Data no
259008
Author
MSD Animal Health
Title
Notification Letter
Study date
June 2023
Publication
-
Authorising party
Applicant

BRAVECTO 500 MG FLURALANER SPOT-ON SOLUTION FOR MEDIUM DOGS

Application Date

26-Sep-2023

Application Number

141421

Application Details

Product name

BRAVECTO 500 MG FLURALANER SPOT-ON SOLUTION FOR MEDIUM DOGS

Product no

82796

Applicant name

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product label approval.

Active constituents

Active constituent name

80697 - FLURALANER

Description of data provided

Data no
259009
Author
MSD Animal Health
Title
Notification Letter
Study date
June 2023
Publication
-
Authorising party
Applicant

BRAVECTO 250 MG FLURALANER SPOT-ON SOLUTION FOR SMALL DOGS

Application Date

26-Sep-2023

Application Number

141422

Application Details

Product name

BRAVECTO 250 MG FLURALANER SPOT-ON SOLUTION FOR SMALL DOGS

Product no

82797

Applicant name

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product label approval.

Active constituents

Active constituent name

80697 - FLURALANER

Description of data provided

Data no
259010
Author
MSD Animal Health
Title
Notification Letter
Study date
June 2023
Publication
-
Authorising party
Applicant

BRAVECTO 112.5 MG FLURALANER SPOT-ON SOLUTION FOR VERY SMALL DOGS

Application Date

26-Sep-2023

Application Number

141423

Application Details

Product name

BRAVECTO 112.5 MG FLURALANER SPOT-ON SOLUTION FOR VERY SMALL DOGS

Product no

82798

Applicant name

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product label approval.

Active constituents

Active constituent name

80697 - FLURALANER

Description of data provided

Data no
259011
Author
MSD Animal Health
Title
Notification Letter
Study date
June 2023
Publication
-
Authorising party
Applicant

EASIFLEX JOINT HEALTH POWDER FOR HORSES

Application Date

25-Sep-2023

Application Number

141412

Application Details

Product name

EASIFLEX JOINT HEALTH POWDER FOR HORSES

Product no

69644

Applicant name

ABBEY LABORATORIES PTY LTD

Application purpose and description of use

Variation to align Current Vet labelling Code

Active constituents

Active constituent name

84174 - GLUCOSAMINE HYDROCHLORIDE

Glufosinate-Ammonium

Application Date

25-Sep-2023

Application Number

141153

Application Details

Product name

Glufosinate-Ammonium

Active name

Glufosinate-Ammonium

Applicant name

BASF AUSTRALIA LTD.

Application purpose and description of use

Approval of Glufosinate-Ammonium for use in agricultural chemical products.

Description of data provided

Data no
257768
Author
Anon
Title
DoC -TK50
Study date
20/12/2022
Publication
-
Authorising party
Applicant
Auth party contact address
LEVEL 12, 28 FRESHWATER PLACE SOUTHBANK Australia

Glufosinate-Ammonium

Application Date

25-Sep-2023

Application Number

141156

Application Details

Product name

Glufosinate-Ammonium

Active name

Glufosinate-Ammonium

Applicant name

BASF AUSTRALIA LTD.

Application purpose and description of use

Approval of Glufosinate-Ammonium for use in agricultural chemical products

Description of data provided

Data no
257785
Author
Anon
Title
DoC - TK50
Study date
31/01/2023
Publication
-
Authorising party
Applicant

Glufosinate-Ammonium

Application Date

25-Sep-2023

Application Number

141157

Application Details

Product name

Glufosinate-Ammonium

Active name

Glufosinate-Ammonium

Applicant name

BASF AUSTRALIA LTD.

Application purpose and description of use

Approval of Glufosinate-Ammonium for use in agricultural chemical products

Description of data provided

Data no
257791
Author
Anon
Title
DoC - TK50
Study date
21/12/2022
Publication
-
Authorising party
Applicant

FLUOPYRAM

Application Date

22-Sep-2023

Application Number

141145

Application Details

Product name

FLUOPYRAM

Active name

FLUOPYRAM

Applicant name

Qilu SYNVA Pharmaceutical Co., Ltd.

Application purpose and description of use

Approval of Fluopyram for use in agricultural chemical products.

Description of data provided

Data no
257790
Author
Anon
Title
Statement
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
257787
Author
Anon
Title
Manufacturing Process of Fluopyram TC
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
257788
Author
Anon
Title
Specification for Fluopyram TC
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
257786
Author
V Damnjanovic
Title
Determination of the active content and impurity profile of Fluopyram
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
257789
Author
X Yu
Title
Declaration of composition
Study date
August 2023
Publication
-
Authorising party
Applicant

Lincomycin Hydrochloride

Application Date

22-Sep-2023

Application Number

141122

Application Details

Product name

Lincomycin Hydrochloride

Active name

Lincomycin Hydrochloride

Applicant name

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use

Approval of active for use in veterinary chemical products.

Description of data provided

Data no
257678
Author
Anon
Title
Certificate of Analysis
Study date
30/4/2020
Publication
n/a
Authorising party
Applicant
Data no
257676
Author
Anon
Title
Certificate of Analysis
Study date
30/4/2020
Publication
n/a
Authorising party
Applicant
Data no
257677
Author
Anon
Title
Certificate of Analysis
Study date
29/4/2020
Publication
n/a
Authorising party
Applicant

Fluazuron

Application Date

22-Sep-2023

Application Number

141348

Application Details

Product name

Fluazuron

Active name

Fluazuron

Applicant name

ABBEY LABORATORIES PTY LTD

Application purpose and description of use

The Purpose of this application is to register active Fluazuron for use in our veterinary chemical products

Description of data provided

Data no
258827
Author
Abbey Laboratories Pty Ltd
Title
Flurazon V2 Part 1 of 2 dossier
Study date
SEP 23
Publication
FluazuronV2 Part1 of 2.pdf;23371547
Authorising party
Applicant
Data no
258828
Author
Abbey Laboratories Pty Ltd
Title
Flurazon V2 Part 2 of 2 dossier
Study date
SEP 23
Publication
FluazuronV2 Part 2 of 2.pdf;32589464
Authorising party
Applicant

F.S.A. Pyroxasulfone 850 WG Herbicide

Application Date

22-Sep-2023

Application Number

141355

Application Details

Product name

F.S.A. Pyroxasulfone 850 WG Herbicide

Product no

92777

Applicant name

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use

Variation of product registration to add a formulation.

Active constituents

Active constituent name

64067 - PYROXASULFONE

Active constituent name

91671 - PYROXASULFONE

Description of data provided

Data no
258864
Author
anon
Title
Support for FSA - formulation
Study date
September 2023
Publication
-
Authorising party
Applicant
Data no
258865
Author
anon
Title
Access to CCI and Protected data
Study date
September 2023
Publication
-
Authorising party
Applicant

Reference Details

89148 - Conquest Preceed 850 WG Herbicide

CLOMICALM 5 TABLETS FOR DOGS AND CATS

Application Date

22-Sep-2023

Application Number

141373

Application Details

Product name

CLOMICALM 5 TABLETS FOR DOGS AND CATS

Product no

50183

Applicant name

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use

Variation of product registration to add an overseas site of manufacture.

Active constituents

Active constituent name

54897 - CLOMIPRAMINE HYDROCHLORIDE

Active constituent name

86769 - CLOMIPRAMINE HYDROCHLORIDE

Description of data provided

Data no
258915
Author
Anon
Title
GMP certificate
Study date
Jan 2023
Publication
-
Authorising party
Applicant
Data no
258916
Author
Virbac
Title
Application for modification
Study date
Aug 2023
Publication
n/a
Authorising party
Applicant
Data no
258914
Author
A Holdsworth
Title
Cover letter - Clomicalm 5 variation
Study date
Sep 2023
Publication
n/a
Authorising party
Applicant

CLOMICALM 20 TABLETS FOR DOGS

Application Date

22-Sep-2023

Application Number

141374

Application Details

Product name

CLOMICALM 20 TABLETS FOR DOGS

Product no

50184

Applicant name

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use

Variation of product registration to add an overseas site of manufacture.

Active constituents

Active constituent name

54897 - CLOMIPRAMINE HYDROCHLORIDE

Active constituent name

86769 - CLOMIPRAMINE HYDROCHLORIDE

Description of data provided

Data no
258918
Author
Anon
Title
GMP certificate
Study date
Jan 2023
Publication
-
Authorising party
Applicant
Data no
258919
Author
Virbac
Title
Application for modification
Study date
Aug 2023
Publication
n/a
Authorising party
Applicant
Data no
258917
Author
A Holdsworth
Title
Cover letter - Clomicalm 20 variation
Study date
Sep 2023
Publication
n/a
Authorising party
Applicant

CLOMICALM 80 TABLETS FOR DOGS

Application Date

22-Sep-2023

Application Number

141386

Application Details

Product name

CLOMICALM 80 TABLETS FOR DOGS

Product no

50185

Applicant name

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use

Variation of product registration to add an overseas site of manufacture.

Active constituents

Active constituent name

54897 - CLOMIPRAMINE HYDROCHLORIDE

Active constituent name

86769 - CLOMIPRAMINE HYDROCHLORIDE

Description of data provided

Data no
258921
Author
A Holdsworth
Title
Cover letter - Clomicalm 80 variation
Study date
Sep 2023
Publication
n/a
Authorising party
Applicant
Data no
258922
Author
Anon
Title
GMP certificate
Study date
Jan 2023
Publication
-
Authorising party
Applicant
Data no
258923
Author
Virbac
Title
Application for modification
Study date
Aug 2023
Publication
n/a
Authorising party
Applicant

CAMPBELL CHEERS 720 FLOWABLE FUNGICIDE

Application Date

22-Sep-2023

Application Number

141393

Application Details

Product name

CAMPBELL CHEERS 720 FLOWABLE FUNGICIDE

Product no

56005

Applicant name

COLIN CAMPBELL (CHEMICALS) PTY LTD

Application purpose and description of use

Variation of label approval to update Directions for Use

Active constituents

Active constituent name

44206 - CHLOROTHALONIL

Reference Details

52518 - SIPCAM ECHO 720 FUNGICIDE
63122 - CAMPBELL CHEERS 720 WEATHERSHIELD FUNGICIDE

Molidustat

Application Date

22-Sep-2023

Application Number

140895

Application Details

Product name

Molidustat

Product no

93913

Applicant name

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use

This application is to apply for the registration of Varenzin oral suspension for cats which contains 25 mg/mL of
molidustat. Approval of the API will be undertaken concurrently with this application.

The proposed indication is for the treatment of anaemia associated with Chronic Kidney Disease (CKD) in cats.

Varenzin Oral Solution for Cats

Application Date

22-Sep-2023

Application Number

140896

Application Details

Product name

Varenzin Oral Solution for Cats

Product no

93914

Applicant name

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use

This application is to apply for the registration of Varenzin oral suspension for cats which contains 25 mg/mL of
molidustat. Approval of the API will be undertaken concurrently with this application.

The proposed indication is for the treatment of anaemia associated with Chronic Kidney Disease (CKD) in cats.

Description of data provided

Data no
257306
Author
Fraatz, K.
Title
Report 46687 - PK study formulation
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257312
Author
Gmelin C
Title
Report 46296 (D) - Ocular irritation study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257329
Author
Himmel H
Title
Report 38887 (D) - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257335
Author
Wingenroth M
Title
Report 46315 - Skin irritation study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257358
Author
Bruick, R.K.; and McKnight,S.L.
Title
A Conserved Family of Prolyl-4-Hydroxylases That Modify HIF.
Study date
2001
Publication
Science Vol. 294, Issue 5545, pp. 1337-1340. DOI: 10.1126/science.1066373
Authorising party
Public
Auth party contact address
-
Data no
257429
Author
Schladt L
Title
Report 38902 (D) - Sub-chronic study lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257398
Author
Herbold B
Title
Report 38893 (D) - DNA synthesis rat liver
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257352
Author
Sternberg J
Title
Report 38906 (D) - Developmental study rats
Study date
2015
Publication
-
Authorising party
Applicant
Data no
257435
Author
Schladt L
Title
Report 38901f (D) - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257289
Author
Sander J
Title
Report 44240e - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257389
Author
Ellinger- Ziegelbauer et al,
Title
Report 38899 - Phototoxicity assay
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257346
Author
Sternberg J
Title
Report 38907 - Developmental study rabbits
Study date
2015
Publication
-
Authorising party
Applicant
Data no
257295
Author
APVMA
Title
Ref 2 - Project plan
Study date
1 August 2023
Publication
-
Authorising party
Applicant
Data no
257392
Author
Anon
Title
Report 46790 - Investigators Brochure API
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257415
Author
Schladt L
Title
Report 38901a - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257315
Author
Hoffmann M
Title
Report 38883 - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257409
Author
Ruf J
Title
Report 38888 - Short term study dogs
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257421
Author
Schladt L
Title
Report 38903a - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257366
Author
Anon
Title
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Study date
2012
Publication
ICH Topic S10. EMA/CHMP/ICH/752211/2012.
Authorising party
Public
Auth party contact address
-
Data no
257372
Author
Anon
Title
FDA. (2007). Summary basis for approval of Mircera (BLA 125164).Pharmacology reviews a,b
Study date
2007
Publication
-
Authorising party
Applicant
Data no
257309
Author
Gehrke H
Title
Report 45163 (D) - Dermal absorption study
Study date
2017
Publication
-
Authorising party
Applicant
Data no
257286
Author
Sander J
Title
Report 44240b - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257401
Author
Himmel H
Title
Report 38885 (D) - toxicology additonal data
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257378
Author
Herbold B
Title
Report 38891 - Micronucleus test - mice
Study date
2007
Publication
-
Authorising party
Applicant
Data no
257355
Author
Semenza, G.L
Title
Hypoxia-Inducible Factors in Physiology and Medicine
Study date
2012
Publication
Cell. 2012 February 3; 148(3): 399???408. doi:10.1016/j.cell.2012.01.021
Authorising party
Public
Auth party contact address
-
Data no
257432
Author
Schladt L
Title
Report 38901c (D) - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257332
Author
Leidenfrost P
Title
Report 46355 (D) - Ocular irritation study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257303
Author
Gerisch M
Title
Report PH-39762 - Metabolism other
Study date
2017
Publication
-
Authorising party
Applicant
Data no
257386
Author
Hirai, O et al
Title
Prior bleeding enhances the sensitivity of the in vivo micronucleus test
Study date
1991
Publication
Mutation Research Letters 264, 109- 11
Authorising party
Public
Auth party contact address
-
Data no
257292
Author
Sander J
Title
Report 44240c (D) - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257349
Author
Barraclough N
Title
Report 46940 (D) Developmental study rats
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257338
Author
Wingenroth M
Title
Report 46320 (D) - Skin sensitization study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257395
Author
Flamme I
Title
46938 (D) - toxicology additional data
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257438
Author
Schladt L
Title
Report 38903c (D) - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257326
Author
Gillissen U
Title
Report 38895 (D) - Acute toxicity
Study date
2009
Publication
-
Authorising party
Applicant
Data no
257375
Author
Lange, C.A.K. et al
Title
Von Hipple- Lindau protwin in the RPE is essential for normal ocular growth and vascular development.
Study date
2012
Publication
Development 139: 2340- 2350
Authorising party
Public
Auth party contact address
-
Data no
257412
Author
Schladt L
Title
Report 38896 (D) - Short term oral lab animal
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257318
Author
Hucke F, Schwarz T.
Title
Report 44082 - Oral and intravenous toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257369
Author
Hucke F et al
Title
Report 44083 - Oral and intravenous toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257418
Author
Schladt L
Title
Report 38901d - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257333
Author
Van Huygeyoort
Title
Report 46287 (D) - Skin sensitization study
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257404
Author
Elanco Australasia Pty Ltd
Title
APVMA Part 3 Toxicology Overview
Study date
1 August 2023
Publication
-
Authorising party
Applicant
Data no
257310
Author
Leidenfrost P
Title
Report 46355 - Ocular irritation study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257427
Author
Ruf J
Title
Report 38898 (D) - Sub-chronic study dogs
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257287
Author
Sander J
Title
Report 44240c - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257381
Author
Suzuki Y et al
Title
Effect of erythroietin on the micronucleus test.
Study date
1989
Publication
Environmental and Molecular Mutagenesis 13, 314- 318
Authorising party
Public
Auth party contact address
-
Data no
257304
Author
Gerisch M
Title
Report PH-37906 - Metabolism other animals
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257433
Author
Schladt L
Title
Report 38901d (D) - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257350
Author
Schmuck G
Title
Report 44312 - Critical evaluation developmental toxicity
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257387
Author
Steinheider, G et al
Title
Evaluation of nongenotoxic and genotoxic factors modulating the frequency of micronucleated erythrocytes in the peripheral blood of mice
Study date
1985
Publication
Cell Biology and Toxicology 1, 197- 211 1985
Authorising party
Public
Auth party contact address
-
Data no
257341
Author
Martin T
Title
Report 46913 (D) - Carcinogenicity study rats
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257396
Author
Heidary G et al
Title
Retinopathy of Prematurity: Current concepts in Molecular Pathogenesis
Study date
2009
Publication
Seminars in Ophthalmology 24:2, 77-81
Authorising party
Public
Auth party contact address
-
Data no
257321
Author
Hucke F. et al.
Title
Report 44088 - Oral and iv toxicology
Study date
2011
Publication
-
Authorising party
Applicant
Data no
257327
Author
Himmel H
Title
Report 38889 (D) - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257364
Author
Flamme I
Title
Report 46937 - toxicology other information
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257413
Author
Anon
Title
EFSA 2017. Re- evaluation of mono- and diglycerides of fatty acids (E471) as food additives
Study date
2017
Publication
EFSA Journal 15: 5045
Authorising party
Public
Auth party contact address
-
Data no
257370
Author
Fricke R
Title
Report 44091 - Toxicology additional information
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257330
Author
Hoffman M
Title
Report 38883 (D)- Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257407
Author
G.Schmuck
Title
Apx 3-3 - User Safety Risk Assessment
Study date
1 August 2023
Publication
-
Authorising party
Applicant
Data no
257353
Author
Sternberg J
Title
Report 38907 (D) - Developmental study rabbits
Study date
2015
Publication
-
Authorising party
Applicant
Data no
257384
Author
Yajima, N. et al
Title
Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietins
Study date
1993
Publication
Mutagenesis 8, 237- 241
Authorising party
Public
Auth party contact address
-
Data no
257307
Author
Biswas S & Bader M.
Title
Ref 36 - Metabolism other information
Study date
2022
Publication
-
Authorising party
Applicant
Data no
257430
Author
Schladt L
Title
Report 38901a (D) - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257290
Author
Sander J
Title
Report 44240a (D) - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257301
Author
Hucke F
Title
Report PH-40564 - Metabolism lab animals
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257436
Author
Schladt L
Title
Report 38903a (D) - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257347
Author
Barraclough N
Title
Report 46940 - Developmental study rats
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257390
Author
Anon
Title
EFSA, 2012. Scientific opinion on the re- evaluation of butylated hydroxytoluene BHT (E 321) as a food additive.
Study date
2012
Publication
EFSA Journal 2012: 10: 2588
Authorising party
Public
Auth party contact address
-
Data no
257344
Author
Sternberg J
Title
Report 38905 - Developmental study rats
Study date
2014
Publication
-
Authorising party
Applicant
Data no
257393
Author
Becker K, Naumann T
Title
Report 38890 (D) - Forward cell mutation
Study date
2009
Publication
-
Authorising party
Applicant
Data no
257416
Author
Schladt L
Title
Report 38901b - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257298
Author
Steinke W
Title
Report 44092 - Pharmacological distribution data rats
Study date
2015
Publication
-
Authorising party
Applicant
Data no
257410
Author
Ruf J
Title
Report 38888 (D) - Short term study dogs
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257361
Author
Schofield, C.J; Ratcliffe, P.J.
Title
Oxygen sensing by HIF hydroxylases.
Study date
2004
Publication
Nature Reviews Molecular Cell Biology Vol. 5, 343???354
Authorising party
Public
Auth party contact address
-
Data no
257373
Author
Heinicke K et al
Title
Excessive erythrocytosis in adult mice overexpressing erythropoietin leads to hepatic, renal, neuronal, and muscular degeneration
Study date
2006
Publication
A.J.Physiol.Regul.Integr.Comp.Physiol. 291, R947- R956
Authorising party
Public
Auth party contact address
-
Data no
257424
Author
Ruf J
Title
Report 38898 - Sub-chronic study dogs
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257324
Author
Schladt L
Title
Report 38900 - sub-acute oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257367
Author
Bartels D
Title
Report 38882 - other information
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257285
Author
Sander J
Title
Report 44240a - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257425
Author
Ruf J
Title
Report 38904 - Sub-chronic study dogs
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257431
Author
Schladt L
Title
Report 38901b (D) - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257402
Author
Anon
Title
Report 46790 (D) - Investigators Brochure API
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257408
Author
Schladt L
Title
Report 38896 - Sub-acute oral lab animals
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257379
Author
Herbold B
Title
Report 38894 - Cytogenetic study mice
Study date
2011
Publication
-
Authorising party
Applicant
Data no
257356
Author
Wang, G.; Semenza, G. L.
Title
Molecular basis of hypoxia-induced erythropoietin expression.
Study date
1996
Publication
Curr.Opin.Hematol.3; 156- 162
Authorising party
Public
Auth party contact address
-
Data no
257339
Author
Martin T
Title
Report 46913 - Carcinogenicity study rats
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257302
Author
Radke M
Title
Report 44094 - Metabolism other information
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257385
Author
Yaijma N et al
Title
Induction of micronucleated erythrocytes by recombinant human erythropoietin
Study date
1993
Publication
Mutagenesis 8, 221-229
Authorising party
Public
Auth party contact address
-
Data no
257348
Author
Barraclough N
Title
Report 46941 - Developmental study rats
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257293
Author
Sander J
Title
Report 44240d (D) - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257439
Author
Schladt L
Title
Report 38903d (D) - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257299
Author
Gerisch M
Title
Report 44098 - Metabolism lab animal
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257376
Author
Herbold B
Title
Report 38892 - Salmonella/Microsome test
Study date
2009
Publication
-
Authorising party
Applicant
Data no
257313
Author
Himmel H
Title
Report 38889 - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257325
Author
Beckmann R
Title
38884 (D) - toxicology additonal data
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257362
Author
Beck, H.; et al
Title
Ref 8 Toxicology other information
Study date
2017
Publication
ChemMedChem 2018, 13, 988 ??? 1003
Authorising party
Public
Auth party contact address
-
Data no
257411
Author
Schladt L
Title
Report 38900 (D) - Short term lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257419
Author
Schladt L
Title
Report 38901e - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257319
Author
Hucke F et al
Title
Report 44084 - Oral toxicology
Study date
2011
Publication
-
Authorising party
Applicant
Data no
257368
Author
Himmel H
Title
Report 38885 - toxicology additional data
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257428
Author
Ruf J
Title
Report 38904 (D) - Sub-chronic study dogs
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257336
Author
Wingenroth M
Title
Report 46320 - Skin sensitization study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257359
Author
Epstein, A.C.R.; et al
Title
C. elegans EGL-9 and Mammalian Homologs Define a Family of Dioxygenases that Regulate HIF by Prolyl Hydroxylation.
Study date
2001
Publication
Cell, Vol. 107, 43???54,
Authorising party
Public
Auth party contact address
-
Data no
257305
Author
Gerisch M
Title
Report 44101 - Metabolism other
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257382
Author
Suzuki Y et al
Title
The micronucleus test and erythropoiesis. Effects of erythropoietin and a mutagen on the ratio of polychromatic to normochromatic erythrocytes (P/ N ratio).
Study date
1989
Publication
Mutagenesis 4, 420- 424
Authorising party
Public
Auth party contact address
-
Data no
257405
Author
G. Schmuck
Title
42176 - summary user safety
Study date
17 June 2015
Publication
-
Authorising party
Applicant
Data no
257388
Author
Tweats D.J et al
Title
Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests: I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazard
Study date
2007
Publication
Mutation Research/ Genetic Toxicology and Environmental Mutagenesis 627, 78- 91
Authorising party
Public
Auth party contact address
-
Data no
257399
Author
Herbold B
Title
Report 38891 (D) - Micronucleus test - mice
Study date
2007
Publication
-
Authorising party
Applicant
Data no
257342
Author
Popp L
Title
Report 46939 (D) - Carcinogenicity study mice
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257296
Author
Fricke R
Title
Report 48239 - Plasma protein binding various species
Study date
2015
Publication
-
Authorising party
Applicant
Data no
257345
Author
Sternberg J
Title
Report 38906 - Developmental study rats
Study date
2015
Publication
-
Authorising party
Applicant
Data no
257322
Author
Van Pijpen, F.M.
Title
Report 48019 - Oral and iv toxicology
Study date
2021
Publication
-
Authorising party
Applicant
Data no
257422
Author
Schladt L
Title
Report 38903b - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257316
Author
Beckmann R
Title
Report 38884 - toxicology additional data
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257328
Author
Himmel H
Title
Report 38886 (D) - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257365
Author
Flamme I
Title
Report 46938 - toxicology other in
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257354
Author
Schmuck G
Title
Report 44313 - Critical evaluation genotoxicity
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257360
Author
Min, J.H.; et al
Title
Structure of a HIF-1??-pVHL Complex: Hydroxyproline Recognition in Signaling.
Study date
2001
Publication
Science:Vol. 296, Issue 5574, pp. 1886-1889, DOI: 10.1126/science.1073440
Authorising party
Public
Auth party contact address
-
Data no
257377
Author
Becker K, Naumann T
Title
Report 38890 - Forward cell mutation
Study date
2009
Publication
-
Authorising party
Applicant
Data no
257383
Author
Yajima,N. et al
Title
Genotoxicity of genetic recombinant human erythropoietin in a novel test system
Study date
1993
Publication
Mutagenesis 8, 231- 236
Authorising party
Public
Auth party contact address
-
Data no
257308
Author
Gehrke H
Title
Report 45163 - Dermal absorption study
Study date
2017
Publication
-
Authorising party
Applicant
Data no
257406
Author
G. Schmuck
Title
3-2 - Applicant Written Summary (EU) Part 3a Safety
Study date
26 July 2023
Publication
-
Authorising party
Applicant
Data no
257331
Author
Fraatz, K.
Title
Report 46688 - Formulation Oral toxicity
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257291
Author
Sander J
Title
Report 44240b (D) - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257400
Author
Herbold B
Title
Report 38894 (D) - Cytogenetic study mice
Study date
2011
Publication
-
Authorising party
Applicant
Data no
257337
Author
Van Huygeyoort
Title
Report 46287 - Skin sensitization study
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257437
Author
Schladt L
Title
Report 38903b (D) - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257391
Author
Anon
Title
EFSA, 2019. Opinion of the follow-up reevaluation of sorbic acid (E 200) and potassium sorbate (E 202) as Food additives.
Study date
2019
Publication
EFSA Journal 17: 5625
Authorising party
Public
Auth party contact address
-
Data no
257394
Author
Flamme I
Title
Report 46937 (D) - toxicology additional data
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257343
Author
Barraclough N
Title
Report 46941 (D) - Developmental study rats
Study date
2019
Publication
-
Authorising party
Applicant
Data no
257297
Author
Fricke R
Title
Report 44112 -Plasma protein binding various species
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257323
Author
Gillissen U
Title
Report 38895 - Acute toxicology oral
Study date
2009
Publication
-
Authorising party
Applicant
Data no
257801
Author
Anon
Title
GMP Evidence
Study date
2021
Publication
-
Authorising party
Applicant
Data no
257374
Author
Frietsch, T et al
Title
Reduced cerebral blood flow but elevated cerebral glucose metabolic rate in erythropoietin overexpressing transgenic mice with excessive erythrocytosis
Study date
2007
Publication
Journal of Cerebral Blood Flow & Metabolism 27, 469????????476
Authorising party
Public
Auth party contact address
-
Data no
257423
Author
Ruf J
Title
Report 38897 - Sub-chronic study dogs
Study date
2011
Publication
-
Authorising party
Applicant
Data no
257317
Author
Himmel H
Title
Report 38887 - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257417
Author
Schladt L
Title
Report 38901c - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257357
Author
Wenger, R.H.; Hoogewijs,D.
Title
Regulated oxygen sensing by protein hydroxylation in renal erythropoietin-producing cells.
Study date
2010
Publication
Am J Physiol Renal Physiol 298: F1287???F1296, doi:10.1152/ajprenal.00736.2009.
Authorising party
Public
Auth party contact address
-
Data no
257334
Author
Wingenroth M
Title
Report 46315 (D) - Skin irritation study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257311
Author
Gmelin C
Title
Report 46296 - Ocular irritation study
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257288
Author
Sander J
Title
Report 44240d - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257426
Author
Ruf J
Title
Report 38897 (D) - Sub-chronic study dogs
Study date
2011
Publication
-
Authorising party
Applicant
Data no
257403
Author
Lange, C.A.K. et al
Title
Von Hipple- Lindau protein in the RPE is essential for normal ocular growth and vascular development.
Study date
2012
Publication
Development 139: 2340- 2350
Authorising party
Public
Auth party contact address
-
Data no
257380
Author
Herbold B
Title
Report 38893 - DNA synthesis rat liver
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257351
Author
Sternberg J
Title
Report 38905 (D) - Developmental study rats
Study date
2014
Publication
-
Authorising party
Applicant
Data no
257434
Author
Schladt L
Title
Report 38901e (D) - Sub-chronic oral lab animals
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257340
Author
Popp L
Title
Report 46939 - Carcinogenicity study mice
Study date
2018
Publication
-
Authorising party
Applicant
Data no
257397
Author
Herbold B
Title
Report 38892 (D) - Salmonella/Microsome test
Study date
2009
Publication
-
Authorising party
Applicant
Data no
257294
Author
Sander J
Title
Report 44240e (D) - TAS
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257300
Author
Gerisch M
Title
Report PH-37906 - Metabolism lab animal
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257363
Author
Flamme I
Title
Report PH36104 - toxicology other information
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257314
Author
Himmel H
Title
Report 38886 - Oral toxicology
Study date
2010
Publication
-
Authorising party
Applicant
Data no
257371
Author
Lang D
Title
Report 44093 - Toxicology additional information
Study date
2016
Publication
-
Authorising party
Applicant
Data no
257414
Author
Schladt L
Title
Report 38902 - sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257420
Author
Schladt L
Title
Report 38901f - Sub-chronic oral lab animal
Study date
2012
Publication
-
Authorising party
Applicant
Data no
257320
Author
Hucke F, Thuss U.
Title
Report 44087 - Oral and iv toxicology
Study date
2015
Publication
-
Authorising party
Applicant

LEVABAMAX COMBINATION POUR-ON FOR CATTLE

Application Date

22-Sep-2023

Application Number

141121

Application Details

Product name

LEVABAMAX COMBINATION POUR-ON FOR CATTLE

Product no

93975

Applicant name

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use

Registration of a 10 mg/ mL abamectin, 200 mg/ mL levamisole pour-on product for the treatment and control of roundworms, including macrocyclic lactones or levamisole resistant strains, and external parasites in cattle.

Active constituents

Active constituent name

83372 - Abamectin

Active constituent name

83379 - Levamisole

Description of data provided

Data no
257674
Author
Anon
Title
Product specification
Study date
23/6/2023
Publication
In-house
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia

Reference Details

60752 - ECLIPSE COMBINATION POUR-ON FOR CATTLE

ULTRATHOR X WATER-BASED TERMITICIDE AND INSECTICIDE

Application Date

22-Sep-2023

Application Number

141406

Application Details

Product name

ULTRATHOR X WATER-BASED TERMITICIDE AND INSECTICIDE

Product no

64449

Applicant name

ENSYSTEX AUSTRALASIA PTY LTD

Application purpose and description of use

Variation of product registration and label approval to modify the Directions for Use and general instructions.

Active constituents

Active constituent name

58418 - FIPRONIL

Description of data provided

Data no
258950
Author
S Broadbent
Title
Field Evaluation Of The Effectiveness Of ULTRATHOR Against A Range Of Ant Species.
Study date
16/01/2012
Publication
-
Data no
258952
Author
BASF Australia Ltd
Title
Termidor Residual Termiticide and Insecticide label 54624/121259
Study date
18/10/2019
Publication
-
Authorising party
Public
Auth party contact address
-
Data no
258949
Author
S Broadbent
Title
Field Evaluation of the Effectiveness of ULTRATHOR??? Water-based Termiticide and Insecticide against a range of ant species in Western Australia
Study date
11/09/2023
Publication
-
Authorising party
Applicant
Data no
258953
Author
BASF Australia Ltd
Title
Termidor HE Residual Termiticide label 80820/108128
Study date
31/05/2017
Publication
-
Authorising party
Public
Auth party contact address
-
Data no
258948
Author
S Broadbent
Title
Field Evaluation of the Effectiveness of ULTRATHOR??? X Water-based Termiticide and Insecticide against a range of ant species in Queensland
Study date
11/09/2023
Publication
-
Authorising party
Applicant
Data no
258951
Author
APVMA
Title
Agricultural chemicals efficacy and safety technical report
Study date
18/01/2023
Publication
-
Authorising party
Applicant
Data no
258954
Author
F Johnston
Title
Part 8 Summary
Study date
September 2023
Publication
-
Authorising party
Applicant

IMTRADE METHOMYL 225 INSECTICIDE

Application Date

22-Sep-2023

Application Number

141410

Application Details

Product name

IMTRADE METHOMYL 225 INSECTICIDE

Product no

63201

Applicant name

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use

Variation of product registration and label approval to amend Pack Size Range from 1L-200L to 1L-1000L to allow for greater marketability of product along with updating the Product Label by addition of Spray Drift Restraints, referring to the product as METHOMYL 225 through, update of Application comments, update of Storage & Disposal Instructions to accommodate new Pack Size Range, update of Safety Directions and update of First Aid Instructions.

Active constituents

Active constituent name

59753 - METHOMYL

Description of data provided

Data no
258995
Author
N/A
Title
Imtrade Methomyl 225 Insecticide - RLP_V1 pending 18/09/2023 MARKED COPY
Study date
18/09/2023
Publication
-
Authorising party
Applicant
Data no
258994
Author
APVMA
Title
Advice of NV submission for product 63201
Study date
07/06/2022
Publication
-
Authorising party
Applicant

Reference Details

92346 - IMTRADE ACTIVIST 225 VERIPHY SL INSECTICIDE

Sulfadimidine

Application Date

21-Sep-2023

Application Number

141341

Application Details

Product name

Sulfadimidine

Active name

Sulfadimidine

Applicant name

INCA (FLIGHT) CO PTY LTD

Application purpose and description of use

Approval of pharmacopoeia active constituent.

Description of data provided

Data no
258803
Author
Anon
Title
Certificate of Analysis 210314 BP2012 Sulphadimidine
Study date
March 2021
Publication
Sulphadimidine 210314 - 20126.pdf;533755
Authorising party
Applicant
Data no
258804
Author
Anon
Title
Certificate of Analysis 201235 BP2012 Sulphadimidine
Study date
December 2020
Publication
-
Authorising party
Applicant
Data no
258904
Author
Anon
Title
Sulphadimidine CoAs
Study date
2021
Publication
-
Authorising party
Applicant
Data no
258805
Author
Anon
Title
Sulfadimidine Ph. Eur. monograph 0295
Study date
2012
Publication
MOA FOR SULFADIMIDINE(2012).pdf;87239
Authorising party
Applicant
Data no
258802
Author
Anon
Title
Certificate of Analysis 211023 BP2012 Sulphadimidine .
Study date
October 2021
Publication
Sulphadimidine 211023 - 20341 (1).pdf;258018
Authorising party
Applicant

CEPRALOCK

Application Date

21-Sep-2023

Application Number

141366

Application Details

Product name

CEPRALOCK

Product no

89964

Applicant name

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use

Variation of product registration to extend product shelf life

Active constituents

Active constituent name

57108 - BISMUTH SUBNITRATE

Description of data provided

Data no
258892
Author
Intervet/MSD
Title
Executive Summary
Study date
14 September 2023
Publication
-
Authorising party
Applicant
Data no
258893
Author
John Hayes
Title
Stability Report
Study date
12 August 2022
Publication
-
Authorising party
Applicant
Data no
258894
Author
MSD Animal Health
Title
Product Specifications
Study date
July 2023
Publication
-
Authorising party
Applicant

Dimethomorph Technical

Application Date

21-Sep-2023

Application Number

141394

Application Details

Product name

Dimethomorph Technical

Active name

Dimethomorph Technical

Applicant name

Shandong Rainbow International Co Ltd

Application purpose and description of use

Approval of Dimethomorph Technical for use in agricultural chemical products.

Description of data provided

Data no
258932
Author
anon
Title
The Statement of Batch Size of Dimethomorph Technical in 5-Batch Report
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258929
Author
Anon
Title
MANUFACTURE PROCESS OF DIMETHOMORPH TECHNICAL
Study date
2020
Publication
-
Authorising party
Applicant
Data no
258930
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF DIMETHOMORPH TECHNICAL
Study date
2020
Publication
-
Authorising party
Applicant
Data no
258927
Author
Yasser Sokeirik
Title
Chemistry &Manufacturing Dossier
Study date
05/09/2023
Publication
-
Authorising party
Applicant
Data no
258933
Author
anon
Title
COA
Study date
JUL. 20, 2023
Publication
-
Authorising party
Applicant
Data no
258928
Author
Vlado Damnjanovic
Title
Determination of Active Content and Impurity Profile of Dimethomorph
Study date
13 Mar 2020
Publication
-
Authorising party
Applicant
Data no
258931
Author
Anon
Title
Doc
Study date
2023
Publication
-
Authorising party
Applicant

ACIBENZOLAR-S-METHYL

Application Date

20-Sep-2023

Application Number

141300

Application Details

Product name

ACIBENZOLAR-S-METHYL

Active name

ACIBENZOLAR-S-METHYL

Applicant name

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use

Approval of Acibenzolar-S-Methyl for use in agricultural products.

Description of data provided

Data no
258663
Author
Huang, S-B.
Title
Statement on IR Spectra of Acibenzolar-S-Methyl technical
Study date
17 June 2021
Publication
-
Authorising party
Applicant
Data no
258669
Author
Huang, S-B.
Title
CGA245704 - Determination of by-products in CGA245704 Technical by High Performance Liquid Chromatography and Gas Chromatography
Study date
02 May 2016
Publication
-
Authorising party
Applicant
Data no
258660
Author
Nayyar, P.
Title
Part 2 - Chemistry and Manufacture
Study date
04 September 2023
Publication
-
Authorising party
Applicant
Data no
258666
Author
Nayyar, P.
Title
Declaration of Composition
Study date
21 August 2023
Publication
-
Authorising party
Applicant
Data no
258661
Author
Huang, S-B.
Title
Statement on UV wavelength screening of Acibenzolar-S-Methyl technical by Diode Array Detector
Study date
17 June 2021
Publication
-
Authorising party
Applicant
Data no
258664
Author
Huang, S-B.
Title
Statement on Mass Spectra of Acibenzolar-S-Methyl Technical
Study date
17 June 2021
Publication
-
Authorising party
Applicant
Data no
258667
Author
Mittapalli, R.
Title
Acibenzolar-S-Methyl (CGA245704) - Analysis of Five Representative batches
Study date
03 August 2023
Publication
-
Authorising party
Applicant
Data no
258670
Author
Huang, S-B.
Title
Acibenzolar-S-Methyl Technical (CGA245704) - Validation of Analytical Method SA-1241
Study date
10 March2016
Publication
-
Authorising party
Applicant
Data no
258665
Author
Lumbroso, A.
Title
Manufacturing Process - Acibenzolar-S-Methyl
Study date
20 April 2021
Publication
-
Authorising party
Applicant
Data no
258671
Author
Perine, S.
Title
CGA245704 - Validation of Analytical method SB-124/1
Study date
02 August 2016
Publication
-
Authorising party
Applicant
Data no
258662
Author
Huang, S-B.
Title
Statement in NMR Spectra of Acibenzolar-S-Methyl technical
Study date
17 June 2021
Publication
-
Authorising party
Applicant
Data no
258668
Author
Huang, S-B.
Title
CGA245704 - Determination of CGA245704 in Acibenzolar-S-Methyl technical by Gas Chromatography - SA-124/1
Study date
15 February 2016
Publication
-
Authorising party
Applicant

TIAMUPHARM LIQUID

Application Date

20-Sep-2023

Application Number

141342

Application Details

Product name

TIAMUPHARM LIQUID

Product no

59465

Applicant name

ABBEY LABORATORIES PTY LTD

Application purpose and description of use

Variation of product label approval to align the label with the current Vet Labelling Code.

Active constituents

Active constituent name

82709 - TIAMULIN HYDROGEN FUMARATE

Active constituent name

56387 - TIAMULIN FUMARATE

Active constituent name

84120 - TIAMULIN HYDROGEN FUMARATE

MS MegaDes Novo

Application Date

19-Sep-2023

Application Number

140596

Application Details

Product name

MS MegaDes Novo

Product no

93827

Applicant name

STOCKYARD INDUSTRIES PTY LTD

Application purpose and description of use

Registration of a Glutaraldehyde and Alkyl (C12C16) dimethylbenzylammoniumchloride product for use as a disinfectant for animal housing and vehicles used for animal transport.

Description of data provided

Data no
256834
Author
MS Gold
Title
Product stability MS MegaDes Novo
Study date
2023
Publication
-
Authorising party
Applicant
Data no
256831
Author
Schippers Europe BV
Title
MS MegaDes Novo Product Composition
Study date
23 August 2023
Publication
-
Authorising party
Applicant
Data no
256837
Author
MS Gold
Title
Leaflet information
Study date
2023
Publication
-
Authorising party
Applicant
Data no
256828
Author
SLS Lommel BV
Title
Certificate of conformity ISO
Study date
2023
Publication
-
Authorising party
Applicant
Data no
256829
Author
MS Gold
Title
MS MegaDes Novo Product Data Sheet
Study date
September 2022
Publication
-
Authorising party
Applicant
Data no
256832
Author
MS Gold
Title
Production information MS MegaDes Novo
Study date
2023
Publication
-
Authorising party
Applicant
Data no
256835
Author
MS Gold
Title
MS MegaDes Novo Efficacy test
Study date
2023
Publication
-
Authorising party
Applicant
Data no
256836
Author
The Schippers Group
Title
Packaging information & label MS MegaDes Novo
Study date
2023
Publication
-
Authorising party
Applicant
Data no
256833
Author
SLS Lommel BV
Title
Benzalkonium chloride determination (Bardac DM50) 3.
Study date
09/01/22
Publication
-
Authorising party
Applicant
Data no
256830
Author
SLS Lommel BV
Title
CERTIFICATE OF ANALYSIS
Study date
02/04/23
Publication
-
Authorising party
Applicant

Reference Details

88612 - TH5 Broad Spectrum Disinfectant against Bacteria, Fungi and Viruses

Metacoxx Oral Suspension for Cats

Application Date

19-Sep-2023

Application Number

141061

Application Details

Product name

Metacoxx Oral Suspension for Cats

Product no

83287

Applicant name

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use

Variation of product registration and label approval to introduce an additional pack size and update sites of manufacture.

Active constituents

Active constituent name

82924 - Meloxicam

Description of data provided

Data no
257510
Author
Dechra Veterinary Products (Australia)
Title
Stability tables
Study date
19 June 2023
Publication
Unpublished
Authorising party
Applicant
Data no
257511
Author
M Chu
Title
Product Specification and Drawing
Study date
27 October 2014
Publication
Unpublished
Authorising party
Applicant
Data no
257509
Author
Dechra Veterinary Products (Australia)
Title
Chemistry 4
Study date
August 2023
Publication
Unpublished
Authorising party
Applicant

SPIROTETRAMAT

Application Date

19-Sep-2023

Application Number

141212

Application Details

Product name

SPIROTETRAMAT

Active name

SPIROTETRAMAT

Applicant name

Hebei Lanrun Plant Protection Technology Co., Ltd.

Application purpose and description of use

Approval of SPIROTETRAMAT for use in agricultural chemical products.

Description of data provided

Data no
258448
Author
Y Rong
Title
Preliminary Analysis and Validation of Analytical Methods of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TC
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258451
Author
W Ciming
Title
Declaration of composition
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258446
Author
W Ciming
Title
Available packages for Spirotetramat TC
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258452
Author
Anon
Title
Preliminary Analysis and Enforcement Analytical Method of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TC
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258449
Author
Anon
Title
Preliminary Analysis and Validation of Analytical Methods of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TC
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258450
Author
Anon
Title
Preliminary Analysis and Enforcement Analytical Method of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TC
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258447
Author
W Ciming
Title
Statement of 5 Batch Size and typical batch size of Spirotetramat Technical
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258445
Author
W Ciming
Title
Spirotetramat manufacturing process and impurities formation description.
Study date
June 2023
Publication
-
Authorising party
Applicant

Cyproconazole

Application Date

19-Sep-2023

Application Number

141356

Application Details

Product name

Cyproconazole

Active name

Cyproconazole

Applicant name

SHANGHAI E-TONG CHEMICAL CO LTD

Application purpose and description of use

Approval of cyproconazole for use in agricultural chemical products.

Description of data provided

Data no
258866
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Part 2 Chemistry and Manufacturing
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258872
Author
Shanghai E-Tong Chemical Co., Ltd
Title
COA of cyproconazole technical
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258869
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Five Batches Analysis of Cyproconazole TGAI, Amendment No1 to Final Report, Study Number R-23-500(1-5)
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258870
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Declaration of Composition (DoC), Declaration of Manufacture (DoM) and Letter of Support for Cyproconazole TGAI,
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258873
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Cyproconazole MATERIAL SAFETY DATA SHEET
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258867
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Description Of Manufacturing Process Of Cyproconazole And Impurity Information of CyproconazoleTechnical
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258868
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Five Batches Analysis of Cyproconazole TGAI, Study Number R-23-500(1-5)
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258871
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Analysis method for cyproconazole technical
Study date
2023
Publication
-
Authorising party
Applicant

Keaks Clean Veterinary Disinfectant

Application Date

19-Sep-2023

Application Number

141369

Application Details

Product name

Keaks Clean Veterinary Disinfectant

Product no

94058

Applicant name

INTERCHEM PTY LTD

Application purpose and description of use

Registration of a 54g/L Benzalkonium chloride and 4g/L Poly (hexamethylene biguanide hydrochloride) liquid concentrate product for multipurpose disinfectant for all hard surfaces, equipment and airspaces.

Description of data provided

Data no
258899
Author
Interchem Pty Ltd
Title
Product Specifications
Study date
13/09/2023
Publication
-
Authorising party
Applicant

Reference Details

54149 - F10SC VETERINARY DISINFECTANT

Kresoxim-methyl

Application Date

18-Sep-2023

Application Number

140992

Application Details

Product name

Kresoxim-methyl

Active name

Kresoxim-methyl

Applicant name

UNITED CROPSCIENCE PTE., LTD.

Application purpose and description of use

Approval of Kresoxim-methyl for use in agricultural chemical products.

Description of data provided

Data no
257089
Author
C Lu
Title
Explanation letter for change of name
Study date
May 2023
Publication
-
Authorising party
Applicant
Data no
257086
Author
C Lu
Title
Packing Specification of Kresoxim-methyl Technical
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257083
Author
F Ning
Title
Technical Report Industrial Synthesis and Formation of Impurities. KRESOXIM - METHYL
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257081
Author
J Skopec
Title
Determination of active constituent and impurity profile of Kresoxim-methyl
Study date
November 2016
Publication
-
Authorising party
Applicant
Data no
257084
Author
C Lu
Title
Declaration of composition
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257087
Author
C Lu
Title
Statement of 5 Batch Size and Typical Batch Size of Kresoxim-methyl Technical
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257082
Author
J Skopec
Title
Determination of active constituent and impurity profile of Kresoxim-methyl
Study date
November 2016
Publication
-
Authorising party
Applicant
Data no
257088
Author
Anon
Title
Statement for Manufacturing Process
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257085
Author
Anon
Title
Analytical method of Kresoxim-methyl and validation
Study date
July 2023
Publication
-
Authorising party
Applicant

Trifloxystrobin

Application Date

18-Sep-2023

Application Number

141088

Application Details

Product name

Trifloxystrobin

Active name

Trifloxystrobin

Applicant name

UNITED CROPSCIENCE PTE., LTD.

Application purpose and description of use

Approval of Trifloxystrobin for use in agricultural chemical products.

Description of data provided

Data no
257627
Author
T Lei
Title
Trifloxystrobin Technical Manufacture process
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257630
Author
C Lu
Title
Packing Specification of Trifloxystrobin Technical
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257633
Author
C Lu
Title
Explanation letter for the change of name
Study date
May 2023
Publication
-
Authorising party
Applicant
Data no
257631
Author
C Lu
Title
Statement of 5 Batch Size and Typical Batch Size of Trifloxystrobin Technical
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257628
Author
C Lu
Title
Declartion of composition
Study date
August 2023
Publication
-
Authorising party
Applicant
Data no
257629
Author
Anon
Title
Analysis of active ingredient Trifloxystrobin by HPLC-UV
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
257632
Author
Anon
Title
Material Safety Data Sheet
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
257626
Author
Vlado Damnjanovic
Title
Determination of Active Content and Impurity Profile of Trifloxystrobin
Study date
April 2020
Publication
-
Authorising party
Applicant

Abamectin

Application Date

18-Sep-2023

Application Number

141174

Application Details

Product name

Abamectin

Active name

Abamectin

Applicant name

UNITED CROPSCIENCE PTE., LTD.

Application purpose and description of use

Approval of Abamectin for use in agricultural chemical products.

Description of data provided

Data no
258225
Author
ANON
Title
Validation of the method for determination of the active ingredient in Abamectin Technical
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258228
Author
Y Shengwei
Title
Statement of 5 Batch Size and Typical Batch Size of Abamectin Technical
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258222
Author
G. A. Quiorato
Title
Preliminary Analysis, Enforcement Analytical Method & Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)
Study date
November 2017
Publication
-
Authorising party
Applicant
Data no
258223
Author
G. A. Quiorato
Title
Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)
Study date
09/2017
Publication
-
Authorising party
Applicant
Data no
258226
Author
Z Yang
Title
Declaration of composition
Study date
July 2023
Publication
-
Authorising party
Applicant
Data no
258220
Author
G. A. Quiorato
Title
Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)
Study date
September 2016
Publication
-
Authorising party
Applicant
Data no
258229
Author
Y Wang
Title
Statement for manufacturing process
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258221
Author
G. A. Quiorato
Title
Preliminary Analysis, Enforcement Analytical Method & Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)
Study date
September 2017
Publication
-
Authorising party
Applicant
Data no
258227
Author
Y Shengwei
Title
Packing Specification of Abamectin Technical
Study date
June 2023
Publication
-
Authorising party
Applicant
Data no
258224
Author
G Juncong
Title
MANUFACTURING PROCESS OF ABAMECTIN 95 % TECH
Study date
July 2023
Publication
-
Authorising party
Applicant

Vanquish Glypho 540 Herbicide

Application Date

18-Sep-2023

Application Number

141302

Application Details

Product name

Vanquish Glypho 540 Herbicide

Applicant name

HEART AGRICULTURAL PTY LTD

Application purpose and description of use

Registration of a 540 g/L glyphosate present as the potassium salt SL soluble concentrate product for use as a non-selective herbicide for the control of many annual and perennial weeds.

EXPEDIENT SPRAY ADJUVANT

Application Date

18-Sep-2023

Application Number

141312

Application Details

Product name

EXPEDIENT SPRAY ADJUVANT

Product no

70378

Applicant name

AUSTRALIAN ADJUVANTS PTY LTD

Application purpose and description of use

Variation of label approval to make a minor change to the active constituent statement.

Active constituents

Active constituent name

60725 - ETHYL ESTERS OF CANOLA OIL FATTY ACIDS

Description of data provided

Data no
258718
Author
Applicant
Title
Expedient Item 12 Background & Proposal
Study date
Sep 2023
Publication
-
Authorising party
Applicant

Demovit Herbicide

Application Date

18-Sep-2023

Application Number

141315

Application Details

Product name

Demovit Herbicide

Product no

94039

Applicant name

Shandong Rainbow International Co Ltd

Application purpose and description of use

Registration of a 340 g/L MCPA (present as the dimethylamine salt) 80 g/L DICAMBA (present as the dimethylamine salt) Soluble Concentrate (SL) product For the control of certain broadleaf weeds in winter cereals, pastures and non-crop areas..

Active constituents

Active constituent name

53708 - DICAMBA

Active constituent name

56234 - MCPA

Reference Details

86775 - OZCROP DICAMBA-M SL HERBICIDE

APIGUARD GEL FOR BEEHIVES

Application Date

18-Sep-2023

Application Number

141329

Application Details

Product name

APIGUARD GEL FOR BEEHIVES

Product no

65570

Applicant name

VITA (EUROPE) LIMITED

Application purpose and description of use

Variation of product registration to change the overseas site of manufacture.

Description of data provided

Data no
258764
Author
Anon
Title
Evidence of GMP
Study date
Nov 2022
Publication
N/A
Authorising party
Applicant

Mortein Naturgard Crawling Insect Control Bomb Eucalyptus Scent

Application Date

18-Sep-2023

Application Number

141338

Application Details

Product name

Mortein Naturgard Crawling Insect Control Bomb Eucalyptus Scent

Product no

90976

Applicant name

RB (HYGIENE HOME) AUSTRALIA PTY LTD

Application purpose and description of use

Variation of product registration and label approval to amend product specification and make changes to label text.

Active constituents

Active constituent name

61830 - PERMETHRIN

F.S.A. LV Ester 680 Herbicide

Application Date

18-Sep-2023

Application Number

141349

Application Details

Product name

F.S.A. LV Ester 680 Herbicide

Product no

87250

Applicant name

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use

Variation of product registration to add a formulation.

Active constituents

Active constituent name

61699 - 2,4-D-2-ETHYLHEXYL ESTER

Active constituent name

68068 - 2,4-D-2-ETHYLHEXYL ESTER

Active constituent name

47190 - 2,4-D-2-ETHYLHEXYL ESTER

Active constituent name

61329 - 2,4-D-2-ETHYLHEXYL ESTER

Description of data provided

Data no
258863
Author
anon
Title
Support for FSA - formulation
Study date
September 2023
Publication
-
Authorising party
Applicant

Reference Details

69446 - AC ESCORT 680 HERBICIDE

Pyridaben

Application Date

15-Sep-2023

Application Number

141224

Application Details

Product name

Pyridaben

Active name

Pyridaben

Applicant name

SHANDONG UNITED PESTICIDE INDUSTRY CO., LTD

Application purpose and description of use

Approval of (active) for use in agricultural and/or veterinary (delete as necessary) chemical products.

Description of data provided

Data no
258483
Author
Ms. Jing Bao
Title
Declaration of Composition (DoC) for Pyridaben from a New Manufacturing Source
Study date
25/06/2023
Publication
-
Authorising party
Applicant
Data no
258491
Author
Ms. Jing Bao
Title
Justification of impurities in Pyridaben from a New Manufacturing Source
Study date
24/06/2023
Publication
-
Authorising party
Applicant
Data no
258492
Author
Anon
Title
PART 2 CHEMISTRY AND MANUFACTURE - New Source of Approved Active Constituent Pyridaben
Study date
10/06/2023
Publication
-
Authorising party
Applicant
Data no
258489
Author
Anon
Title
COA Sodium methoxide
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258486
Author
Anon
Title
COA 2-(tert-butyl)-4, 5-dichloro-2, 3-dihydropyridazin-3-one
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258487
Author
Anon
Title
COA 4-(tert-Butyl)benzyl mercaptan
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258484
Author
Li Jufang
Title
Five Batches Analysis of Pyridaben TC
Study date
6/5/2023
Publication
-
Authorising party
Applicant
Data no
258490
Author
Anon
Title
RAW MATERIAL SPECIFICATIONS FOR PYRIDABEN MANUFACTURING
Study date
2023
Publication
-
Authorising party
Applicant
Data no
258485
Author
Li Jufang
Title
Confidential attachment Five Batches Analysis of Pyridaben TC
Study date
06/05/2023
Publication
-
Authorising party
Applicant
Data no
258482
Author
Ms. Jing Bao
Title
Manufacturing Process and Quality Control of Pyridaben from a new manufacturing source
Study date
26/06/2023
Publication
-
Authorising party
Applicant
Data no
258488
Author
Anon
Title
COA Methanol
Study date
2023
Publication
-
Authorising party
Applicant

IMTRADE ONQUIT 825 WG INSECTICIDE

Application Date

15-Sep-2023

Application Number

141326

Application Details

Product name

IMTRADE ONQUIT 825 WG INSECTICIDE

Product no

91867

Applicant name

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use

Variation of product registration and label approval to extend uses into Almonds, Pome Fruit, Stone Fruit, Brassica Leafy Vegetables, Stalk & Stem Vegetables, Leafy Vegetables, Lettuce Fruiting Vegetables, Legume Vegetables, Strawberries, Sweetcorn, Cotton, Winter Pulse Crops & Summer Pulse Crops as per the Directions for Use.

Active constituents

Active constituent name

88973 - CHLORANTRANILIPROLE

Description of data provided

Data no
258752
Author
N/A
Title
Investigation into the Bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE when compared to CORAGEN INSECTICIDE for the control of Cotton Earworm (Helicoverpa armigera) in Sweetcorn cv. ???Max??? (Zea mays) ??? One Trial, Kuitpo, South Australia.
Study date
14/07/2022
Publication
-
Authorising party
Applicant
Data no
258760
Author
N/A
Title
Comments to Support Efficacy and Host Crop Safety Data submitted.
Study date
01/09/2023
Publication
-
Authorising party
Applicant
Data no
258749
Author
N/A
Title
Investigation into the bio-efficacy of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of CORAGEN INSECTICIDE for the control of Diamondback Moth on Brussel Sprouts cv. Divino ??? One Trial, Langhorne Creek, South Australia.
Study date
30/11/2021
Publication
-
Authorising party
Applicant
Data no
258755
Author
N/A
Title
Investigation into the bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE for the control of Lepidopteran Pests in Cowpea cv. Ebony. ??? One Trial, South Kolan, Queensland
Study date
24/11/2022
Publication
-
Authorising party
Applicant
Data no
258761
Author
N/A
Title
Imtrade ONQUIT?? 825 WG Insecticide - RLP_V1 pending 060923 MARKED COPY
Study date
06/09/2023
Publication
-
Authorising party
Applicant
Data no
258758
Author
N/A
Title
Investigation of the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to CORAGEN INSECTICIDE in Greenhouse Cucumber cv. Lebanese ??? One Trial, Kwinana, Western Australia.
Study date
18/07/2023
Publication
-
Authorising party
Applicant
Data no
258753
Author
N/A
Title
Investigation into the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of ALTACOR INSECTICIDE for the control of Lepidopteran Pests in a commercial Faba Bean cv. Samira crop. - One Trial, Saddleworth, South Australia.
Study date
8/02/2023
Publication
-
Authorising party
Applicant
Data no
258759
Author
N/A
Title
Investigation of the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to CORAGEN INSECTICIDE when applied as a foliar treatment to Greenhouse Spinach cv. Viking ??? One Trial, Kwinana, Western Australia.
Study date
31/08/2023
Publication
-
Authorising party
Applicant
Data no
258750
Author
N/A
Title
Investigation into the bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of CORAGEN INSECTICIDE for the control of Lepidopteran Pests of Pumpkin cv. Queensland Blue ??? One Trial, Kalbar, Queensland.
Study date
13/12/2021
Publication
-
Authorising party
Applicant
Data no
258756
Author
N/A
Title
Investigation into the bio-equivalency of IMTRADE ONQUIT 825 WG INSECTICIDE for the control of Cotton Bollworm in Cotton cv. Sicot 711RRF ??? One Trial, Forest Hill, Queensland.
Study date
16/02/2023
Publication
-
Authorising party
Applicant
Data no
258757
Author
N/A
Title
Investigation of the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to CORAGEN INSECTICIDE in Greenhouse Lettuce cv. Iceberg. One Trial, Kwinana, Western Australia
Study date
14/07/2023
Publication
-
Authorising party
Applicant
Data no
258754
Author
N/A
Title
Investigation into the Bio-efficacy of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to ALTACOR INSECTICIDE for the control of Cotton Bollworm in Cotton cv. 746 ??? One Trial, Goondiwindi, Queensland.
Study date
4/03/2022
Publication
-
Authorising party
Applicant
Data no
258751
Author
N/A
Title
Investigation into the bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of CORAGEN INSECTICIDE for the control of Lepidopteran Pests in Bean Vegetable Crop. ??? One Trial, Kalbar, Queensland.
Study date
22/03/2021
Publication
-
Authorising party
Applicant

ORALBUTE ORAL PASTE ANTI-INFLAMMATORY ANALGESIC FOR HORSES

Application Date

14-Sep-2023

Application Number

141004

Application Details

Product name

ORALBUTE ORAL PASTE ANTI-INFLAMMATORY ANALGESIC FOR HORSES

Product no

42362

Applicant name

ABBEY LABORATORIES PTY LTD

Application purpose and description of use

Variation to add new pack sizes.

Suprelorin 4.7 mg

Application Date

14-Sep-2023

Application Number

141204

Application Details

Product name

Suprelorin 4.7 mg

Product no

56107

Applicant name

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use

Variation of product registration and label approval to extend the product claims

Active constituents

Active constituent name

54980 - DESLORELIN AS DESLORELIN ACETATE

Active constituent name

83365 - Deslorelin Acetate

Active constituent name

83391 - Deslorelin Acetate

Active constituent name

85819 - DESLORELIN ACETATE

Description of data provided

Data no
258400
Author
Veliskova J., et al
Title
Sex and Hormonal influences on Seizures and Epilepsy
Study date
Feb 2013
Publication
Horm Behav. 2013 February ; 63(2): 267????????277
Authorising party
Public
Auth party contact address
-
Data no
258285
Author
Braun G.
Title
Braun, 2021-60006-protocol
Study date
Oct 2019
Publication
n/a
Authorising party
Applicant
Data no
258371
Author
Romagnoli S, et al
Title
Duration of control of reproductive function following administration of a single 4.7 mg Deslorelin implant in adult tomcats and effect on testicular histology
Study date
Mar 2011
Publication
n/a
Authorising party
Applicant
Data no
258325
Author
Gultiken N
Title
Effect of deslorelin on testicular function, serum dihydrotestosterone and oestradiol concentrations during and after suppression of sexual activity in tom cats
Study date
Nov 2015
Publication
Journal of Feline Medicine and Surgery ??????1???????? 9, 10.1177
Authorising party
Public
Auth party contact address
-
Data no
258331
Author
Johnston S.D.
Title
Sexual Differentiation and Normal Anatomy of the Tom Cat
Study date
2001
Publication
Canine and Feline Theriogenology, Section IV, Ch 36
Authorising party
Public
Auth party contact address
-
Data no
258377
Author
Rumpler E., et al
Title
Kisspeptin Neurons in the Infundibular Nucleus of Ovariectomized Cats and Dogs Exhibit Unique Anatomical and Neurochemical Characteristics
Study date
Dec 2020
Publication
Frontiers in Neuroscience, Dec 2020, Vol 14, Article 598707
Authorising party
Public
Auth party contact address
-
Data no
258385
Author
Shafer-Somi S., et al
Title
Pre-pubertal treatment with a GnRH agonist in bitches-Effect on the uterus and hormone receptor expression
Study date
Aug 2018
Publication
Reprod Dom Anim. 2018;53(Suppl. 3):103????????109
Authorising party
Public
Auth party contact address
-
Data no
258391
Author
anon
Title
Product Monograph Suprefact
Study date
Aug 2015
Publication
Sanofi Canada (yumpu.com)
Authorising party
Public
Auth party contact address
-
Data no
258368
Author
Reichler I.M., et al
Title
The effect of GnRH analogs on urinary incontinence after ablation of the ovaries in dogs
Study date
2003
Publication
Theriogenology 60 (2003) 1207????????1216
Authorising party
Public
Auth party contact address
-
Data no
258268
Author
Gontier A.
Title
gontier-2021-60014 - Efficacy - Reproductive survey study in female dogs
Study date
Mar 2021
Publication
n/a
Authorising party
Applicant
Data no
258291
Author
Concannon P.W.
Title
Reproductive cycles of the domestic bitch
Study date
Aug 2010
Publication
Anim. Reprod. Sci. (2010), doi:10.1016/j.anireprosci.2010.08.028
Authorising party
Public
Auth party contact address
-
Data no
258311
Author
Finch A.R., et al
Title
Agonist-induced internalization and downregulation of gonadotropin-releasing hormone receptors
Study date
Jul 2009
Publication
Am J Physiol Cell Physiol 297: C591????????C600
Authorising party
Public
Auth party contact address
-
Data no
258262
Author
Davis S.
Title
davis-2017-30001 - TAS - spayed female dogs
Study date
Feb 2017
Publication
n/a
Authorising party
Applicant
Data no
258348
Author
Maenhoudt C, et al