For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
141514
Product/Active constituent Name
Application Product Name
verdinexor
Application Date
Application Number
141514
Application Product Name
verdinexor
Application details
Product name:
verdinexor
Product number:
94091
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 50 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Description of data provided:
Data no
260995
Title
CoAs for 3 batches of active
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260996
Title
3.2.S.1 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260994
Title
3.2.S.4 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260999
Title
3.2.S.2 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
261000
Title
3.2.S.6 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
261001
Title
3.2.S.3 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
261002
Title
3.2.S.5 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260997
Title
3.2.S.7 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
277002
Title
TGA non-clinical report
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Date
Application Date
Application No
Application Number
141515
Product/Active constituent Name
Application Product Name
Laverdia 50 mg Tablets for Dogs
Application Date
Application Number
141515
Application Product Name
Laverdia 50 mg Tablets for Dogs
Application details
Product name:
Laverdia 50 mg Tablets for Dogs
Product number:
94092
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 50 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Description of data provided:
Data no
260870
Title
CoAs - Laverdia Tablets
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260867
Title
3.2.P.3 AUS 2022 FINAL - updated v2
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260869
Title
3.2.P.5 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260868
Title
3.2.P.7 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260854
Title
Laverdia - Part 2 - FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260863
Title
3.2.P.1 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260864
Title
CoAs - Excipients
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260865
Title
3.2.P.2 AUS 2022 FINAL - updated
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260866
Title
3.2.P.4 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260871
Title
3.2.P.8 AUS 2022 FINAL - updated
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260872
Title
Laverdia - Part 7 - FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260873
Title
VICH GL6
Study date
2000
Auth party contact address
-
Data no
260847
Title
PAA 136192 - Final Meeting advice
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260848
Title
PAA 136192 - Project Plan_FINAL_signed APVMA
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260849
Title
USFDA CFG - Laverdia 2.5, 10, 50 mg
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260850
Title
EUDRA certificate for manufacturing site
Study date
2018
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260851
Title
Testing Laboratory ISO certificate
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260852
Title
Excipient GRAS report
Study date
1979
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260853
Title
Excipient RDS
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260898
Title
Acute oral study 1
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260899
Title
Acute oral study 2
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260911
Title
Genotoxicity 1
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260912
Title
Genotoxicity 2
Study date
2015
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260913
Title
Genotoxicity 3
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260916
Title
US Product Information - Laverdia-CA1 (verdinexor tablets)
Study date
2022
Auth party contact address
-
Data no
260917
Title
EPAR assessment report
Study date
2021
Auth party contact address
-
Data no
260918
Title
EU 3a5 dossier
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260919
Title
EU 3a3 dossier
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260900
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Auth party contact address
-
Data no
260901
Title
Monographs
Study date
2023
Auth party contact address
-
Data no
260902
Title
Safety data sheets
Study date
2021
Auth party contact address
-
Data no
260903
Title
Food Additive
Study date
2022
Auth party contact address
-
Data no
260904
Title
Safety of ingredient for use in foods
Study date
2023
Auth party contact address
-
Data no
260896
Title
Metabolism and toxicokinetic - TA 6
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260897
Title
Method validation report
Study date
2018
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260907
Title
Exploratory study
Study date
2013
Auth party contact address
-
Data no
260908
Title
Phase II study of the oral selective inhibitor of nuclear export (SINE) KPT-335 (verdinexor) in dogs with lymphoma.
Study date
2018
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260909
Title
Safety study 1
Study date
2019
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260910
Title
SPC
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260874
Title
Laverdia - Part 3 - FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260875
Title
Therapeutic Targeting of Nuclear Export Inhibition in Lung Cancer
Study date
2017
Auth party contact address
-
Data no
260876
Title
CRM1 inhibition induces tumor cell cytotoxicity and impairs osteoclastogenesis in multiple myeloma: molecular mechanisms and therapeutic implications.
Study date
2014
Auth party contact address
-
Data no
260878
Title
XPOVIO public summary
Study date
2022
Auth party contact address
-
Data no
260882
Title
Metabolism and toxicokinetic study - Lab 1
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260886
Title
Metabolism and toxicokinetic - TA 1
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260890
Title
Metabolism and toxicokinetic - TA 2
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260891
Title
Metabolism and toxicokinetic - TA 3
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260892
Title
Metabolism and toxicokinetic - TA 4
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260893
Title
Metabolism and toxicokinetic - TA 5
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260894
Title
EU dossier 3a2
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260887
Title
Metabolism and toxicokinetic / short term toxicity study - TA 2
Study date
2014
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260888
Title
Metabolism and toxicokinetic / short term toxicity study - TA 3
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260889
Title
Metabolism and toxicokinetic / short term toxicity study - TA 4
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260883
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 4
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260884
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 5
Study date
2014
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260885
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 6
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260879
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 1
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260880
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 2
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260881
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 3
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260905
Title
Short term toxicity study 1
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260906
Title
Short term toxicity study 2
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260914
Title
Real World Efficacy and Toxicity of Selinexor: Importance of Patient Characteristics, Dose Intensity and Post Progression Outcomes.
Study date
2023
Auth party contact address
-
Data no
260915
Title
The comeback of Selinexor: From toxic to tolerable.
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260895
Title
Metabolism and toxicokinetic / sub-chronic study - TA
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260877
Title
Preclinical evaluation of the novel, orally bioavailable Selective Inhibitor of Nuclear Export (SINE) KPT-335 in spontaneous canine cancer: results of a phase I study
Study date
2014
Auth party contact address
-
Date
Application Date
Application No
Application Number
141777
Product/Active constituent Name
Application Product Name
Altrenogest
Application Date
Application Number
141777
Application Product Name
Altrenogest
Application details
Product name:
Altrenogest
Active name:
Altrenogest
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Altrenogest for use in veterinary chemical products.
Description of data provided:
Data no
277005
Title
Test Report
Study date
26/06/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
261011
Title
Certificate of Analysis
Study date
18/05/2022
Auth party contact address
71 Milperra Road Revesby Australia
Data no
261012
Title
Certificate of Analysis
Study date
24/11/2022
Auth party contact address
71 Milperra Road Revesby Australia
Data no
261013
Title
Certificate of Analysis
Study date
22/04/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
269111
Title
Chemistry and Manufacturing Documents
Study date
01/06/2020
Auth party contact address
71 Milperra Road Revesby Australia
Data no
270909
Title
Manufacturing controls
Study date
17/04/2024
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
141579
Product/Active constituent Name
Application Product Name
Fluopyram
Application Date
Application Number
141579
Application Product Name
Fluopyram
Application details
Product name:
Fluopyram
Active name:
Fluopyram
Applicant Name:
HAILIR PESTICIDES AND CHEMICALS GROUP CO., LTD
Application purpose and description of use:
Approval of fluopyram for use in agricultural chemical products.
Description of data provided:
Data no
259570
Title
Five Batch Analysis of Fluopyram Technical
Study date
May 2021
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
259571
Title
The Synthesis and Impurities Description of Fluopyram Technical
Study date
October 2023
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
259572
Title
Combined SDSs
Study date
October 2023
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
280129
Title
Explanation Letter of Manufacturing Process
Study date
May 2024
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
280130
Title
The Statement of Batch Size
Study date
May 2024
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
259573
Title
DoC
Study date
August 2023
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Date
Application Date
Application No
Application Number
141062
Product/Active constituent Name
Application Product Name
ERADICAT 1080 FERAL CAT BAIT
Application Date
Application Number
141062
Application Product Name
ERADICAT 1080 FERAL CAT BAIT
Application details
Product name:
ERADICAT 1080 FERAL CAT BAIT
Product number:
65272
Applicant Name:
Department of Biodiversity, Conservation and Attractions
Application purpose and description of use:
Variation to registration and label approval to extend uses to SA, NT and QLD.
Active constituents:
Active constituent name
59861 - SODIUM FLUOROACETATE
Description of data provided:
Data no
270328
Title
Central Rock-rat monitoring and feral cat control in the West MacDonnell Ranges, 2019
Study date
2019
Auth party contact address
Author of report
Data no
270329
Title
Experimental feral cat control using the Eradicat?? bait in the MacDonnell Ranges
Study date
2017
Auth party contact address
Author of report
Data no
270330
Title
Reversing the decline of mammals in northern Australia: response of native mammals to cat management on the Pellew Islands 2011-2015
Study date
2016
Auth party contact address
Author
Data no
270331
Title
West Island summary of bait uptake 2010_2017
Study date
2017
Auth party contact address
Author
Data no
270325
Title
EVALUATION OF DIFFERENT BAITING STRATEGIES FOR THE CONTROL OF FERAL CATS IN EASTERN AUSTRALIA
Study date
2019
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270326
Title
Eradicat trial, Taunton National Park (Scientific) 2017
Study date
2017
Auth party contact address
CO-author of publication, data agreement signed, data not for distribution
Data no
270334
Title
Technical report on Kangaroo Island feral cat research studies and control trials 2016 2018
Study date
2019
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270338
Title
Government Report. Unpublished, pers. comms. Ikara-Flinders Ranges National Park, SA
Study date
2020
Auth party contact address
Authors
Data no
270339
Title
2018 Eradicat? Baiting Trial Phase 2 Interim Results - April 2019
Study date
2019
Auth party contact address
Authors
Data no
270336
Title
Eradicat? baiting trial Ikara-Flinders Ranges National Park
Study date
2017
Auth party contact address
Author
Data no
270343
Title
The use of poison baits to control feral cats and red foxes in arid South Australia I. Aerial baiting trials
Study date
2011
Auth party contact address
-
Data no
270353
Title
Fortescue Marsh Feral Cat Baiting Program (Christmas Creek Water Management Scheme) Year 1 Annual Report
Study date
2012
Auth party contact address
-
Data no
270354
Title
Evaluating the efficacy of a landscape scale feral cat control program using camera traps and occupancy models
Study date
2018
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270355
Title
Fortescue Marsh Feral Cat Baiting Program (Christmas Creek Water Management Scheme) Year 2 Annual Report
Study date
2013
Auth party contact address
-
Data no
270356
Title
Fortescue Marsh Feral Cat Baiting Program (Christmas Creek Water Management Scheme) Year 3 Annual Report
Study date
2014
Auth party contact address
-
Data no
270357
Title
Fortescue Marsh Feral Cat Baiting Program (Christmas Creek Water Management Scheme) Year 4 Annual Report
Study date
2015
Auth party contact address
-
Data no
270358
Title
Fortescue Marsh Feral Cat Baiting Program (Christmas Creek Water Management Scheme) Year 5 Annual Report
Study date
2016
Auth party contact address
-
Data no
270359
Title
Feral cat control as part of Rangelands Restoration at Lorna Glen (Matuwa), Western Australia: the first seven years
Study date
2013
Auth party contact address
-
Data no
270360
Title
Field trial to compare baiting efficacy of Eradicat? and Curiosity? baits
Study date
2011
Auth party contact address
-
Data no
270361
Title
A bait efficacy trial for the management of feral cats on Dirk Hartog Island
Study date
2009
Auth party contact address
-
Data no
270362
Title
Feral cat eradication on Dirk Hartog Island, Western Australia
Study date
2019
Auth party contact address
-
Data no
270363
Title
Cat eradication on Hermite Island, Montabello Islands, Western Australia
Study date
2002
Auth party contact address
-
Data no
270364
Title
Eradication of feral cats on Faure Island, Western Australia
Study date
2010
Auth party contact address
-
Data no
270365
Title
OPERATION WANJARRI: OPTIMISING FERAL CAT BAITING STRATEGIES IN THE ARID ZONE
Study date
2002
Auth party contact address
-
Data no
270366
Title
Response of feral cats to a track-based baiting programme using Eradicat? baits
Study date
2015
Auth party contact address
-
Data no
270367
Title
REMOVAL OF FERAL CATS WITHIN THE FENCED AREA AT BIG LAGOON, PERON PENINSULA
Study date
2011
Auth party contact address
-
Data no
270368
Title
Comparison of two aerial baiting regimes with respect to bait acceptance by introduced predators and non-target native fauna, at the Gibson Desert Nature Reserve, Western Australia
Study date
2002
Auth party contact address
-
Data no
270369
Title
Assessment of bait acceptance by introduced predators from a single aerial deployment of bio-marked baits in the Gascoyne region, Western Australia.
Study date
2002
Auth party contact address
-
Data no
270370
Title
Assessment of the comparative efficacy of two aerial baiting regimes through acceptance of non-toxic baits by feral cats in the north-eastern Goldfields, Western Australia
Study date
2002
Auth party contact address
-
Data no
270371
Title
Field efficacy of the Curiosity? bait for management of a feral cat population at Roxby Downs, South Australia.
Study date
2014
Auth party contact address
-
Data no
270372
Title
Field assessment of the Curiosity? bait for management of feral cats in the Pilbara
Study date
2013
Auth party contact address
-
Data no
270373
Title
Field assessment of the Curiosity? bait for management of Feral Cats after fire at Wilsons Promontory National Park
Study date
2012
Auth party contact address
-
Data no
270374
Title
Field assessment of the Curiosity? bait for management of feral cats in the semi-arid zone (Flinders Ranges National Park).
Study date
2012
Auth party contact address
-
Data no
270375
Title
A bait efficacy trial for the management of feral cats on Christmas Island
Study date
2010
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270376
Title
FERAL CAT BAIT UPTAKE TRIALS 1. SCOTIA SANCTUARY
Study date
2009
Auth party contact address
own report
Data no
270348
Title
Predator Control Baiting and Monitoring Program, Yarraloola and Red Hill, Pilbara Region, Western Australia. 2016 Annual Report - Year 2.
Study date
2017
Auth party contact address
-
Data no
270349
Title
Predator Control Baiting and Monitoring Program, Yarraloola and Red Hill, Pilbara Region, Western Australia. 2017 Annual Report - Year 3.
Study date
2018
Auth party contact address
-
Data no
270350
Title
Predator Control Baiting and Monitoring Program, Yarraloola and Red Hill, Pilbara Region, Western Australia. 2018 Annual Report - Year 4.
Study date
2019
Auth party contact address
-
Data no
270351
Title
Aerial baiting for feral cats is unlikely to affect survivor ship of northern quolls in the Pilbara region of Western Australia
Study date
2020
Auth party contact address
-
Data no
270346
Title
Bait uptake by feral cats on French Island, Victoria.
Study date
2007
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270378
Title
FERAL CAT BAIT UPTAKE TRIALS 2. KANGAROO ISLAND
Study date
2009
Auth party contact address
own report
Data no
270392
Title
Controlling introduced predators in the Gibson Desert WA
Study date
2003
Auth party contact address
-
Data no
270655
Title
DOSSIERS - ERADICAT (R) EFFICACY & ENVIRONMENTAL ASSESMENT
Study date
2020
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270656
Title
Extended Summary of ERADICAT(R) field trials, efficacy and off-target data
Study date
2020
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270344
Title
The use of poison baits to control feral cats and red foxes in arid South Australia II. Bait type, placement, lures and non-target uptake
Study date
2011
Auth party contact address
-
Data no
270332
Title
Uptake of Eradicat? feral cat baits by non-target species on Kangaroo Island
Study date
2019
Auth party contact address
-
Data no
270389
Title
Assessing Risks to Non-Target Species during Poison Baiting Programs for Feral Cats
Study date
2014
Auth party contact address
-
Data no
270390
Title
Electronic supplement assessing risks to non target species during poison baiting programs for feral cats.
Study date
2014
Auth party contact address
-
Data no
270381
Title
A summary of research undertaken to identify non-target risks in the use of the feral cat bait ERADICAT? and encapsulation of the toxin.
Study date
2006
Auth party contact address
-
Data no
270394
Title
SODIUM FLUOROACETATE RESIDUE IN FERAL PIG (SUS SCROFA) CARCASSES. IS IT A SIGNIFICANT SECONDARY POISONING HAZARD?
Study date
2005
Auth party contact address
-
Data no
270379
Title
FERAL CAT BAIT UPTAKE TRIALS 2. KANGAROO ISLAND
Study date
2009
Auth party contact address
own report
Data no
270380
Title
Increasing the target-specificity of ERADICAT? for feral cat (Felis catus) control by encapsulating a toxicant
Study date
2007
Auth party contact address
-
Data no
270347
Title
The northern quoll cat bait uptake and survivorship study, Yarraloola Land Management Area, Pilbara Region, WA.
Study date
2015
Auth party contact address
-
Data no
270352
Title
Aerial baiting for feral cats is unlikely to affect survivor ship of northern quolls in the Pilbara region of Western Australia
Study date
2020
Auth party contact address
-
Data no
270333
Title
Uptake of Eradicat? feral cat baits by non-target species on Kangaroo Island
Study date
2019
Auth party contact address
-
Data no
270335
Title
Technical report on Kangaroo Island feral cat research studies and control trials 2016 2018
Study date
2019
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270327
Title
Evaluation of risks for two native mammal species from feral cat baiting in monsoonal tropical northern Australia
Study date
2018
Auth party contact address
-
Data no
270345
Title
The use of poison baits to control feral cats and red foxes in arid South Australia II. Bait type, placement, lures and non-target uptake
Study date
2011
Auth party contact address
-
Data no
270337
Title
Eradicat? baiting trial Ikara-Flinders Ranges National Park
Study date
2017
Auth party contact address
Author
Data no
270340
Title
2018 Eradicat? Baiting Trial Phase 2 Interim Results - April 2019
Study date
2019
Auth party contact address
Authors
Data no
270341
Title
Using cameras to compare poison uptake by target and non-target species
Study date
2020
Auth party contact address
Authors
Data no
270377
Title
FERAL CAT BAIT UPTAKE TRIALS 1. SCOTIA SANCTUARY
Study date
2009
Auth party contact address
own report
Data no
270342
Title
Raw data: Moseby eradicat bait uptake Flinders Ranges Summary 2020
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270395
Title
Bettongia and Fluoroacetate: a Role for 1080 in Fauna Management
Study date
1981
Auth party contact address
-
Data no
270396
Title
The Sensitivity of Australian Animals to 1080 Poison 11. Marsupial and Eutherian Carnivores
Study date
1981
Auth party contact address
-
Data no
270397
Title
Sodium fluoracetate residues and carcass degradation of free ranging feral pigs poisoned with 1080.
Study date
2005
Auth party contact address
-
Data no
270398
Title
The largest surviving marsupial carnivore on mainland Australia: The tiger or spotted quoll a nationally threatened forest dependant species.
Study date
2004
Auth party contact address
-
Data no
270391
Title
Secondary poisoning risks from 1080 poisoned carcassess and risk of trophic transfer a review.
Study date
2012
Auth party contact address
-
Data no
270393
Title
Measuring, evaluating and improving the effectiveness of invasive predator control programs: feral cat baiting as a case study.
Study date
2021
Auth party contact address
-
Data no
270402
Title
Table S4 Non-toxic Eradicat bait interactions by species
Study date
2021
Auth party contact address
-
Data no
270403
Title
Efficacy and Safety of eradicat baits in Eastern Australia
Study date
2022
Auth party contact address
-
Data no
270404
Title
Efficacy and safety of Eradicat - S1 Sup Info
Study date
2022
Auth party contact address
-
Data no
270405
Title
Does aerial baiting for controlling feral cats in a heterogeneous landscape confer benefits to a threatened native meso-predator?
Study date
2021
Auth party contact address
-
Data no
270406
Title
Field assessment fo the risk of feral cat baits to nontarget species in eastern Australia
Study date
2021
Auth party contact address
-
Data no
270407
Title
Table S2 Toxic Eradicat bait interactions by species.
Study date
2021
Auth party contact address
-
Data no
270408
Title
Table S3 Non-toxic Hisstory bait interaction by species.
Study date
2021
Auth party contact address
-
Data no
270409
Title
Table S1 Decision Tree
Study date
2021
Auth party contact address
-
Data no
270400
Title
The risk to dogs of poisoning from sodium monofluoroacetate residues in possums.
Study date
1997
Auth party contact address
-
Data no
270657
Title
Eradicat bait label national registration_final
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270382
Title
SODIUM FLUOROACETATE FINAL REVIEW REPORT AND REGULATORY DECISION The reconsideration of registrations of products containing sodium fluoroacetate and approvals of their associated labels.
Study date
2008
Auth party contact address
-
Data no
270383
Title
Eradicat Technical Assessment Response Report_final
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270384
Title
Eradicat bait label national registration_final
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270385
Title
Eradicat 1080 Feral Cat Bait SDS2023
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270386
Title
Eradicat Risk Assessment Template for WA SA NT QLD
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270387
Title
Eradicat Risk Assessment Framework-Flinders Example
Study date
2023
Auth party contact address
17 Dick Perry Avenue KENSINGTON Australia
Data no
270388
Title
Eradicat(R) standard operating procedure.
Study date
2023
Auth party contact address
-
Data no
270399
Title
Variationin decompostion stages and carrion insect succession in a dry tropical climate and its effect on estimating postmortem interval.
Study date
2020
Auth party contact address
-
Data no
270401
Title
Deer carcass breakdown monitoring.
Study date
2012
Auth party contact address
-
Date
Application Date
Application No
Application Number
141440
Product/Active constituent Name
Application Product Name
Instructor PP Fungicide
Application Date
Application Number
141440
Application Product Name
Instructor PP Fungicide
Application details
Product name:
Instructor PP Fungicide
Product number:
94074
Applicant Name:
GROW CHOICE PTY LTD
Application purpose and description of use:
Registration of a suspension concentrate formulation of 85 g/L pyraclostrobin + 62.5 g/L prothioconazole for the control of diseases in wheat and barley.
Reference details:
62753 - OPERA FUNGICIDE
63243 - PROSARO 420 SC FOLIAR FUNGICIDE
89172 - Choice Teb Pro 420 Fungicide
Active constituents:
Active constituent name
82863 - PYRACLOSTROBIN
Active constituent name
91982 - Prothioconazole
Description of data provided:
Data no
259412
Title
SDS for inerts
Study date
September 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259410
Title
C of A for active ingredient
Study date
February 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259411
Title
C of A for active ingredient
Study date
March 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259409
Title
Part 2 Chemistry and Manufacture
Study date
September 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259413
Title
Determination of the Physical-chemical properties of Instructor PP Fungicide Suspension Concentrate
Study date
2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259415
Title
EVALUATION OF GROW CHOICE INSTRUCTOR PP FOR CONTROL OF POWDERY MILDEW IN BARLEY TRIAL#: GC-pyra-epoxi-barley-2021 REPORT OF TRIAL CONDUCTED NEAR VICTORIA HILL, QLD
Study date
30 January 2022
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259416
Title
EVALUATION OF THE EFFICACY OF INSTRUCTOR PP FUNGICIDE FOR CONTROL OF SPOT FORM OF NET BLOTCH IN BARLEY
Study date
5 January 2022
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259417
Title
EVALUATION OF THE EFFICACY OF INSTRUCTOR PP FUNGICIDE ON CONTROL OF FUNGAL DISEASE IN CEREALS ONE FIELD TRIAL, CLEVELAND, TASMANIA, AUSTRALIA, 2022
Study date
6 December 2022
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259418
Title
EVALUATION OF THE EFFICACY OF INSTRUCTOR PP FUNGICIDE ON CONTROL OF FUNGAL DISEASE IN CEREALS ONE FIELD TRIAL, OLD JUNEE, NEW SOUTH WALES, AUSTRALIA, 2022
Study date
30 January 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259419
Title
Efficacy of PP Instructor, compared to industry standards, for foliar disease control in wheat cv. Chief Finniss, South Australia, 2022
Study date
21 February 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259414
Title
Part 8 - Efficacy and Crop Safety
Study date
September 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259420
Title
EVALUATION OF GROW CHOICE INSTRUCTOR PP FOR CONTROL OF YELLOW LEAF SPOT IN WHEAT TRIAL#: GC-pyra-epoxi-wheat-2021 REPORT OF TRIAL CONDUCTED AT WEST TALGAI, QLD
Study date
3 February 2022
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259421
Title
EVALUATION OF THE EFFICACY OF INSTRUCTOR PP FUNGICIDE FOR CONTROL OF STRIPE RUST IN WHEAT ONE FIELD TRIAL, WAGGA WAGGA, NEW SOUTH WALES, AUSTRALIA, 2021
Study date
19 January 2022
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
259422
Title
Executive Summary
Study date
15 Sep 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Date
Application Date
Application No
Application Number
141252
Product/Active constituent Name
Application Product Name
[Wagg & Purr] Cefovecin Sodium Lyophilised Powder for Injection
Application Date
Application Number
141252
Application Product Name
[Wagg & Purr] Cefovecin Sodium Lyophilised Powder for Injection
Application details
Product name:
[Wagg & Purr] Cefovecin Sodium Lyophilised Powder for Injection
Product number:
94018
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Registration of an 80 mg/mL cefovecin injectable antibiotic for the treatment of bacterial infections sensitive to
cefovecin in dogs and cats.
Reference details:
60461 - CONVENIA
Description of data provided:
Data no
258510
Title
Product specifications
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
258511
Title
Formulation
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
258516
Title
Declaration
Study date
2023
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
271272
Title
Letter
Study date
2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
258515
Title
GMP certificate
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
141574
Product/Active constituent Name
Application Product Name
HITMAN Organic Insecticide & Fungicide
Application Date
Application Number
141574
Application Product Name
HITMAN Organic Insecticide & Fungicide
Application details
Product name:
HITMAN Organic Insecticide & Fungicide
Product number:
58472
Applicant Name:
VICTORIAN CHEMICAL COMPANY PROPRIETARY LIMITED
Application purpose and description of use:
Variation of label approval to include new use for control of botrytis in grapevines.
Description of data provided:
Data no
259561
Title
Evaluation of Hitman 285 AC for the control of grey mould (Botrytis cinerea) in grapevines cv. Chardonnay
Study date
02.08.2023
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Data no
259563
Title
Application Overview
Study date
03.10.2023
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Data no
259562
Title
Analysis of aqueous soap products
Study date
03.10.2023
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Date
Application Date
Application No
Application Number
141438
Product/Active constituent Name
Application Product Name
GLAIVE 100 EC
Application Date
Application Number
141438
Application Product Name
GLAIVE 100 EC
Application details
Product name:
GLAIVE 100 EC
Product number:
94073
Applicant Name:
YIFAN BIOTECHNOLOGY GROUP CO., LTD.
Application purpose and description of use:
Registration of a 100 g/L Pinoxaden and 25 g/L Cloquintocet-mexyl EC product for for the control of various key grass weeds and selective spray topping of Wild Oats in Wheat and Barley as specified in the Directions for Use table.
Reference details:
59024 - AXIAL 100 EC SELECTIVE HERBICIDE
Active constituents:
Active constituent name
92387 - Pinoxaden
Active constituent name
81464 - Cloquintocet-mexyl
Description of data provided:
Data no
259382
Title
Method Validation Report
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259380
Title
Manufacturing Process including QC
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259381
Title
Material Safety Data Sheet
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259377
Title
Part 2 Chemistry Dossier
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259378
Title
SDS for non-active constituents
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259379
Title
CoA for Active Consituents
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259383
Title
Reference Standard CoAs
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259384
Title
Efficacy Dossier
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259385
Title
Bioequivalence efficacy trial for control of wild oats and crop safety in barley
Study date
October 2022
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259386
Title
Determine bioequivalence of Pinoxaden 100 EC with Axial 100 EC when applied to annual ryegrass in wheat
Study date
June 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
259376
Title
1.1 Executive Summary
Study date
September 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Date
Application Date
Application No
Application Number
141411
Product/Active constituent Name
Application Product Name
PORCILIS PCV M HYO
Application Date
Application Number
141411
Application Product Name
PORCILIS PCV M HYO
Application details
Product name:
PORCILIS PCV M HYO
Product number:
82241
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration add additional site of product manufacture and omit in-process test
Active constituents:
Active constituent name
83163 - PORCINE CIRCOVIRUS TYPE 2 ORF2 SUBUNIT ANTIGEN
Active constituent name
83162 - MYCOPLASMA HYOPNEUMONIAE INACTIVATED STRAIN J
Description of data provided:
Data no
259001
Title
Control tests & release requirements
Study date
June 2018
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
259002
Title
Control tests on finished product_tracked changes
Study date
July 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
259003
Title
Control tests on finished product_clean copy
Study date
July 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262398
Title
Method transfer report KRE-TRA_R-Potency_ELISA
Study date
25 January 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262399
Title
CMS 2022-STAT-198 Statistical analysis method transfer potency ELISA
Study date
10 May 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262400
Title
CMS 2022-STAT-450 Statistical analysis transfer relative potency ELISA
Study date
17 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262401
Title
CMS 2022-STAT-542 Statistical analysis method transfer relative potency ELISA
Study date
28 November 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262402
Title
Sterility test MHyo J & PCVMHyo KRE-VAL_R-Sterility
Study date
19 April 2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262403
Title
Method verification summary report_KRE-VAL_R-Aluminium
Study date
26 January 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262404
Title
Method transfer summary report KRE-TRA_R-Relative Potency ELISA
Study date
25 January 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271031
Title
SOP TI-5089-0002
Study date
27/10/2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271032
Title
SOP GRA-TI-QC-507
Study date
26/10/2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271033
Title
SOP GRA-TI-QC-209
Study date
20/7/2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271034
Title
SOP GRA-TI-QC-207
Study date
20/7/2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271035
Title
SOP TI-4066-0019
Study date
2/11/2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
258996
Title
Manufacturing flowchart
Study date
July 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
258997
Title
GMP 1
Study date
7 June 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
258998
Title
GMP 2
Study date
23 July 2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
258999
Title
GMP 3
Study date
17 May 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
259000
Title
EU Guidance
Study date
11 August 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271037
Title
Manufacturing flowchart
Study date
17/4/2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
278245
Title
SOP TI-4066-0024 Rev 1 pH measurement of vaccines
Study date
2 November 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
278246
Title
Steps of product and antigen manufacture comparison
Study date
19 September 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
278247
Title
Flowchart_AU_corrected (QC test sites)
Study date
19 September 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271030
Title
GMP certificate
Study date
22/1/2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271029
Title
Porcilis PCV MHyo RESPONSE TO APVMA s159
Study date
17/4/2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
271036
Title
Import permit
Study date
6/10/2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
141180
Product/Active constituent Name
Application Product Name
TRYTIME TRIPLE COMBINATION MINERALISED DRENCH FOR SHEEP
Application Date
Application Number
141180
Application Product Name
TRYTIME TRIPLE COMBINATION MINERALISED DRENCH FOR SHEEP
Application details
Product name:
TRYTIME TRIPLE COMBINATION MINERALISED DRENCH FOR SHEEP
Product number:
93997
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
Registration of a 1.0 g/L abamectin, 22.7 g/L oxfendazole, 33.9 g/L levamisole, 0.5 g/L selenium and 2.2 g/L cobalt oral solution product for the control and treatment of internal parasites of sheep and as a selenium and cobalt supplement for sheep raised in selenium and/or cobalt deficient areas.
Reference details:
64649 - TRIGUARD TRIPLE COMBINATION DRENCH FOR SHEEP
Active constituents:
Active constituent name
54693 - ABAMECTIN
Active constituent name
57604 - SODIUM SELENATE
Description of data provided:
Data no
258050
Title
Active certificates of analysis 1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258053
Title
Active certificates of analysis 4
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258055
Title
Active specifications 1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258076
Title
Analytical test methods 1
Study date
2016
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258077
Title
Analytical test method 2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258078
Title
Analytical test method 3
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258079
Title
Analytical test method 4
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258080
Title
Analytical test method 5
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258081
Title
Analytical test method 6
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258082
Title
Analytical validation report 1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258083
Title
Analytical validation protocol 1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258084
Title
Analytical validation report 2
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258085
Title
Analytical validation protocol 2
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258086
Title
Analytical validation report 3
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258087
Title
Analytical validation protocol 3
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258088
Title
Analytical verification report 1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258089
Title
Method verification protocol 1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258090
Title
Method validation report 4
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258091
Title
Method validation protocol 4
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258092
Title
Method validation report 5
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258093
Title
Method validation protocol 5
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258072
Title
Product batch analysis
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258059
Title
VMTR abamectin
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258060
Title
VMTR oxfendazole
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258061
Title
VMTR levamisole
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258062
Title
VMTR selenium
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258063
Title
VMTR cobalt
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258064
Title
AMTR abamectin
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258065
Title
AMTR levamisole
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258066
Title
JPVR 1
Study date
2019
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258067
Title
JPVR 2
Study date
2019
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258068
Title
VPVR 1
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258069
Title
VPVR 2
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258070
Title
APVR 1
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258071
Title
APVR 2
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258073
Title
Packaging
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258074
Title
Product specifications 1
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258075
Title
Product specifications 2
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258057
Title
Excipients certificates of analysis
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258058
Title
Excipients SDS
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258106
Title
Evaluation report
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258049
Title
Part 2 dossier
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271668
Title
Product specifications
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271669
Title
Product specifications justification
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271672
Title
Base-Catalyzed Isomerization of Avermectins
Study date
1988
Auth party contact address
-
Data no
271673
Title
Separation and identification of degradation products in abamectin formulation using LC, LTQ FT-MS, H/D exchange and NMR
Study date
2012
Auth party contact address
-
Data no
271674
Title
Research progress of avermectin: A minireview based on the structural derivatization of avermectin
Study date
2022
Auth party contact address
-
Data no
282515
Title
Trytime specifications justification
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282516
Title
Minidose specifications justification
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282517
Title
Levamisole assessment
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282519
Title
Stability data 2
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282520
Title
Abamectin assessment
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282521
Title
Separation and identification of degradation products in abamectin formulation using LC, LTQ FT-MS, H/D exchange and NMR
Study date
2012
Auth party contact address
-
Data no
282522
Title
Base-Catalyzed Isomerization of Avermectins
Study date
1988
Auth party contact address
-
Data no
282523
Title
An Overview on Chemical Derivatization and Stability Aspects of Selected Avermectin Derivatives
Study date
2012
Auth party contact address
-
Data no
271678
Title
Finished product certificates of analysis
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282518
Title
Stability data 1
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271670
Title
Stability data 1
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271671
Title
Stability data 2
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258094
Title
Stability protocol - pilot
Study date
2017
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258095
Title
Stability pilot information
Study date
2017
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258096
Title
Stability report - pilot
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258097
Title
Stability report 1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258098
Title
Stability report 2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258099
Title
Stability report 3
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258100
Title
Stability report 4
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258101
Title
Stability report 5
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258102
Title
Stability report 6
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258103
Title
Stability protocol - commercial
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258104
Title
Stability report 7
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258105
Title
Stability report 8
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258116
Title
Study N35
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258117
Title
Study N36
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258118
Title
Study N22090
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258119
Title
Study N21317
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258120
Title
Study N22089
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258121
Title
Study N37
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258123
Title
Study N38
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258124
Title
Study N39
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258125
Title
Study N40
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258126
Title
Study N41
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258130
Title
Oxfendazole: Anthelmintic Activity in Sheep Artificially Infected with Nematodes. Results of Trials Against Nine Species Including Benzimidazole-Resistant Haemonchus Contortus.
Study date
1980
Auth party contact address
-
Data no
258131
Title
The efficacy of oxfendazole against naturally acquired Dictyocaulus spp. in sheep and cattle.
Study date
1979
Auth party contact address
-
Data no
258132
Title
Anthelmintic Efficacy of Levamisole against Lungworm (Dictyocaulus filaria) in Lambs.
Study date
1973
Auth party contact address
-
Data no
258133
Title
Avermectins, New Family of Potent Anthelmintic Agents: Efficacy of the B1a Component.
Study date
1979
Auth party contact address
-
Data no
258134
Title
Ivermectin and Abamectin
Study date
1989
Auth party contact address
-
Data no
258135
Title
Controlled trials of the anthelmintic oxfendazole in ewes and lambs naturally infected with gastrointestinal nematodes
Study date
1977
Auth party contact address
-
Data no
258136
Title
Anthelmintic Activity of Levamisole against Nematodirus spathiger and Trichostrongylus axei in Sheep
Study date
1972
Auth party contact address
-
Data no
258137
Title
Efficacy in Sheep and Pharmacokinetics in Cattle that Led to the Selection of Eprinomectin as a Topical Endectocide for Cattle
Study date
1996
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258143
Title
Tetramisole (dl 2,3,5,6-tetrahydro-6-phenyl-imidazo (2,1-b-thiazole hydrochloride Nilverm*) in the Treatment of Gastrointestinal Worms and Lungworms in Domestic Animals. 1. Sheep and Goats.
Study date
1966
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282503
Title
Explanation letter
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258129
Title
Handbook of Pharmaceutical Excipients 6th edn
Study date
2009
Auth party contact address
-
Data no
258114
Title
Part 8 Efficacy and Safety dossier
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258138
Title
Weather report
Study date
2017
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258139
Title
Fast Facts ???????? Australia????????s sheep industry.
Study date
2016
Auth party contact address
-
Data no
258140
Title
Wormwise national worm management strategy handbook
Study date
2019
Auth party contact address
-
Data no
258141
Title
Australia and New Zealand Standard Diagnostic Procedures
Study date
2009
Auth party contact address
-
Data no
258142
Title
Evaluation report
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258127
Title
Declaration
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258122
Title
Method verification report
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258115
Title
Study N43
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258128
Title
Study N42
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258041
Title
GMP 1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258042
Title
GMP 2-1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258043
Title
GMP 2-2
Study date
2019
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258044
Title
GMP 3
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258045
Title
GMP 4
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258046
Title
GMP 5-1
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258047
Title
GMP 5-2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258048
Title
Email advice
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271675
Title
GMP certificate
Study date
2023
Auth party contact address
-
Data no
271676
Title
ISO certificate
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271677
Title
Explanation letter
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
282524
Title
Explanation letter
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258039
Title
APVMA PAA advice
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258040
Title
APVMA appraisal report
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258109
Title
Residue depletion study 1
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258110
Title
Residue depletion study 2
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258111
Title
MRLs for Agricultural Compounds
Study date
2020
Auth party contact address
-
Data no
258112
Title
Product label
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258113
Title
Evaluation report
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258107
Title
Part 5A Residues dossier
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258108
Title
Part 5B Trade dossier
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Date
Application Date
Application No
Application Number
141184
Product/Active constituent Name
Application Product Name
TRYTIME TRIPLE MINIDOSE MINERALISED DRENCH FOR SHEEP
Application Date
Application Number
141184
Application Product Name
TRYTIME TRIPLE MINIDOSE MINERALISED DRENCH FOR SHEEP
Application details
Product name:
TRYTIME TRIPLE MINIDOSE MINERALISED DRENCH FOR SHEEP
Product number:
93998
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
Registration of a 1.0 g/L abamectin, 22.7 g/L oxfendazole, 33.9 g/L levamisole, 0.5 g/L selenium and 2.2 g/L cobalt oral solution product for the control and treatment of internal parasites of sheep and as a selenium and cobalt supplement for sheep raised in selenium and/or cobalt deficient areas.
Reference details:
64649 - TRIGUARD TRIPLE COMBINATION DRENCH FOR SHEEP
Active constituents:
Active constituent name
54693 - ABAMECTIN
Active constituent name
57604 - SODIUM SELENATE
Description of data provided:
Data no
258170
Title
Active certificates of analysis 1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258171
Title
Active certificates of analysis 2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258172
Title
Active certificates of analysis 3
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258173
Title
Active certificates of analysis 4
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258174
Title
Active certificates of analysis 5
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258175
Title
Active specifications 1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258176
Title
Active specifications 2
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258188
Title
Analytical test methods 1
Study date
2016
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258189
Title
Analytical test methods 2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258190
Title
Analytical test methods 3
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258191
Title
Analytical test methods 4
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258192
Title
Analytical test methods 5
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258193
Title
Analytical test methods 6
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258194
Title
Analytical validation report 1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258195
Title
Analytical validation protocol 1
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258196
Title
Analytical verification report 1.1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258197
Title
Analytical verification report 1.2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258198
Title
Analytical validation report 2
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258199
Title
Analytical validation protocol 2
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258200
Title
Analytical verification report 2.1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258201
Title
Analytical verification report 2.2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258202
Title
Analytical validation report 3
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258203
Title
Analytical validation protocol 3
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258204
Title
Analytical verification report 3.1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258205
Title
Analytical verification report 3.2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258206
Title
Analytical verification report 4
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258207
Title
Analytical verification protocol 4
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258208
Title
Analytical validation report 5
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258209
Title
Analytical validation protocol 5
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258210
Title
Analytical validation report 6
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258211
Title
Analytical validation protocol 6
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258212
Title
Analytical verification report 7.1
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258213
Title
Analytical verification report 7.2
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258179
Title
Batch analysis
Study date
2020
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258180
Title
JMVP
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258181
Title
VMVP
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258182
Title
AMVP
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258183
Title
Manufacturing analysis
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258184
Title
Packaging
Study date
2021
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258185
Title
Product specifications 1
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258186
Title
Product specifications 2
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258187
Title
Product specifications 3
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258177
Title
Excipients certificates of analysis
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258178
Title
Excipients SDS
Study date
2018
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271658
Title
Product specifications
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271659
Title
Product specifications justification
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271662
Title
Base-Catalyzed Isomerization of Avermectins
Study date
1988
Auth party contact address
-
Data no
271663
Title
Separation and identification of degradation products in abamectin formulation using LC, LTQ FT-MS, H/D exchange and NMR
Study date
2012
Auth party contact address
-
Data no
271664
Title
Research progress of avermectin: A minireview based on the structural derivatization of avermectin
Study date
2022
Auth party contact address
-
Data no
258169
Title
Part 2 Chemistry and Manufacturing dossier
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271660
Title
Stability data 1
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271661
Title
Stability data 2
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258214
Title
Stability report 1
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258215
Title
Stability report 2
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258216
Title
Stability report 3
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258217
Title
Stability protocol
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258218
Title
Stability justification
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
258219
Title
Stability report 4
Study date
2022
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271665
Title
GMP certificate
Study date
2023
Auth party contact address
-
Data no
271666
Title
ISO certificate
Study date
2023
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
271667
Title
Explanation letter
Study date
2024
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Date
Application Date
Application No
Application Number
141352
Product/Active constituent Name
Application Product Name
Actavan Bio Fruit Protectant
Application Date
Application Number
141352
Application Product Name
Actavan Bio Fruit Protectant
Application details
Product name:
Actavan Bio Fruit Protectant
Product number:
94052
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
259341
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
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259045
Title
Batch analysis sample details : ADS-43 (final product)
Study date
February 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259046
Title
Certificate of Analysis. FG210119-01,
Study date
21 January 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259047
Title
Certificate of Analysis. FG211213-01, Report no. 920493
Study date
22 January 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259048
Title
Certificate of Analysis. FG211213-05. Report no. 940857
Study date
11 May 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259049
Title
Certificate of Analysis. FG220203-01. Rreport no. 940857
Study date
11 May 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259050
Title
CoA
Study date
2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259051
Title
Manufacturing process of ADS-43 (Actavan Bio) including Quality Control Steps
Study date
8 February 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259052
Title
JRC Technical Report. Algae as food and food supplements in Europe.
Study date
2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259053
Title
Derogation EM626.CA_product. Solution dextrait NZBioActive.
Study date
23 March 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259054
Title
Compositional analysis of seaweed extract. report no. 3840
Study date
October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259055
Title
Determination of phytohormones in seaweed extracts. Report no. 3855
Study date
November 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259056
Title
Systemic acquired resistance (50 years after discovery): Moving from the lab to the field.
Study date
5 December 2013
Auth party contact address
-
Data no
259057
Title
Controlling crop diseases using induced resistance: challenges for the future.
Study date
15 January 2013
Auth party contact address
-
Data no
259043
Title
Chemistry and Manufacturing dossier DC2-94174481
Study date
August 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259342
Title
JRC Technical Report. Algae as food and food supplements in Europe.
Study date
2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259307
Title
Viscosity of ADS-43 Report no. S21-09148; ADAMA file no. 000111184
Study date
2002
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259308
Title
Surface tension of ADS-43. Report no. S21-09148; ADAMA file no. 000111184
Study date
2002
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259309
Title
Relative density of ADS-43. Report no. S21-09149; ADAMA file no. 000111183
Study date
2002
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259310
Title
Physico-chemical properties of ADS-43 before and after storage at 0?C for 7 days. Report no. S21-09153, ADAMA 000110981
Study date
25 October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259306
Title
Physico-chemical properties of ADS-43 before and after accelerated storage for 2 weeks at 54?C.
Study date
26 July 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259017
Title
Evaluation of ADS 43 efficacy for grey mould (Botrytis cinerea) control and crop safety in grapevines cv. Riesling. AU-AU-19-1F15-2/A1926
Study date
16 October 2020
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259018
Title
Comparison of ADS 43 + Wetspray 1,000 L with Switch 625WG and Serenade Opti 262WP for control of Botrytis bunch rot (Botrytis cinerea) in grapes
Study date
22 June 2020
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259019
Title
Evaluation of ADS43 and AD-AU-1921 500SC for control of grey mould (Botrytis cinerea) in grapevines cv. Chardonnay. 2020-21 AD-AU-20-FS03-4/KA20-1749
Study date
28 April 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259020
Title
Eval-AD-AU-1921 500SC, AD-AU-1711 592SC, ADS43-programs-control-Botrytis bunch rot (Botrytis cinerea)-winegrapes cv. Marsanne 2021/2. AD-AU-21-FS01-7
Study date
25 July 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259021
Title
Eval of ADS 43 in spray programs-control of Botrytis bunch rot (Botrytis cinerea) in grapevines cv. Sauvignon Blanc. Gawler, Tasmania. 2021-22. AD-AU-21-FS01-8/AD21365
Study date
15 July 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259022
Title
Evaluation of ADS 43 in spray programs for Botrytis in grapes. AD-AU-21-FS01-9.
Study date
July 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259023
Title
Efficacy of various Adama products for control of grey mould of bunches symptoms (caused by Botrytis cinerea) in grapevines cv. Lagrein. AU-AU22-F14-9/AGX22214.
Study date
23 June 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259024
Title
Evaluation of ADS-43 900 SL, AD-AU-1921 500 SC and ADM.01300.F.1 500 SC for the control of grey mould (Botrytis cinerea) in grapevines cv. Chardonnay. Pemberton, Western Australia, 2022-23. AD-AU-22-F14-10.
Study date
9 August 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259025
Title
Comparison of ADS 43 with Switch 625 WG and Serenade Opti 10 WP for the control of grey mould (Botrytis cinerea) in grapevines cv. Chardonnay. Pemberton, Western Australia, 2019-20. AD-AU-19-F15-1/KA19-1546.
Study date
9 April 2020
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259026
Title
Fruitguard For Botrytis Control In Grapes. AD-NZ-18-F03-01/AD1819.
Study date
10 June 2019
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259027
Title
Botrytis Control Grape 2018 2019. AD-NZ-18-F03-02.
Study date
8 March 2019
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259028
Title
Evaluation Of Efficacy Of Fruitguard For Control Of Botrytis In Grapes. AD-NZ-18-F03-03/S18-07159.
Study date
20 June 2019
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259029
Title
ADS-43 Fungicide. An evaluation of botrytis and downy mildew control in grapes. NZ-AD-NZ-20-F02-01/AD2058.
Study date
June 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259030
Title
ADS-43 Efficacy and Crop Safety in Grapes. AD-NZ-20-F02-02/AD2034.
Study date
9 June 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259031
Title
ADS-43 Botrytis Control in Grapes. NZ-20-F02-03/AD2045
Study date
9 June 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259032
Title
ADS-43 Botrytis Control in Grapes. NZ-20-F02-04/AD2045b
Study date
11 June 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259033
Title
Beet extract_Actavan Bio Fruit Protectant efficacy dossier. DC2-94174481.
Study date
7 September 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259014
Title
In vitro study of the antifungal activity of ADS-43 to control phytopathogenic fungi. Adama Report No. 000112001
Study date
2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259015
Title
Controlling crop diseases using induced resistance: challenges for the future.
Study date
15 January 2013
Auth party contact address
-
Data no
259016
Title
Biological activity of glycine betaine and other components in the beer extract.
Study date
December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259089
Title
Biodegradability in the CO2 evolution test according to OECD 301 B of ADS-43. Report No. 1761. ADAMA study no. 000112414.
Study date
2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259090
Title
Aerobic Degradation of Beet Extract in Surface Water. Report No. 1761. ADAMA study no. S23-103844.
Study date
26 June 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259299
Title
Biodegradation of beet extract in the CO2 Evolution Test according to OECD 301B of ADS-43. Report No. 1828. Adama report No. 000116648.
Study date
6 October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259088
Title
Pools and fluxes of osmolytes in moist soil and dry soil that has been re-wet.
Study date
2020
Auth party contact address
-
Data no
259100
Title
Beet extract Acute effects on the water flea Daphnia magna Straus under static laboratory conditions (acute immobilisation test (static) S22-00439 ADAMA no. 000110166. As amended 26 June 2023
Study date
26 June 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259101
Title
Beet extract algae Effects on the single cell green alga Pseudokirchneriella subcapitata Hindak under laboratory conditions. Report No. S22-00440 ADAMA no. 000110167. 20 Dec 2022 amended 26/6/2023
Study date
26 June 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259102
Title
Acute Effects on the Rainbow Trout Oncorhynchus mykiss under Laboratory Conditions (Acute Toxicity Test Static). Report S21-09087/000110855.
Study date
15 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259103
Title
Acute Effects on the Water Flea Daphnia magna Straus under Laboratory Conditions (Acute Immobilisation Test Static). Report S21-09089/000110856.
Study date
19 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259104
Title
Effects on the Single Cell Green Alga Pseudokirchneriella subcapitata Hindk under Laboratory Conditions. Report No. S21-09088/000110858.
Study date
16 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259094
Title
Most abundant metabolites in tissues of freshwater fish pike, perch (Sander lucioperca).
Study date
2020
Auth party contact address
-
Data no
259105
Title
Effects of ADS-43 on the honeybee, Apis mellifera, in an acute oral toxicity test. Study No. APIS-008-007. Adam study No. 000108832.
Study date
24 August 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259106
Title
Effects of ADS-43 on the honeybee, Apis mellifera, in a contact toxicity test. Study No. APIS-008-006. Adam study No. 000108831.
Study date
24 August 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259107
Title
Effects of ADS-43 on the honeybee, Apis mellifera, in a 10-day chronic oral toxicity test. Study No. APS-008-012. Adama Study No. 000110987.
Study date
27 April 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259108
Title
Effects of ADS-43 on honeybee larvae (Apis mellifera) in a repeated exposure toxicity test. Study No. APS-008-011. Adama Study No. 000110988.
Study date
9 June 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259112
Title
ADS-43: Effects on the Reproduction of the Springtail Folsomia candida Willem (Collembola, Isotomidae) in Artificial Soil. Study No. S22-00208/000110860.
Study date
20 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259113
Title
ADS-43: Effects on the Reproduction of the Predatory Mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae) in Artificial Soil. Study No. S22-00209/000110810.
Study date
19 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259109
Title
Effects on Typhlodromus pyri in Tier 1 Laboratory study. Study No. S22-07838/000112731.
Study date
21 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259110
Title
Effects of ADS-43 on the parasitic wasp, Aphidius rhopalosiphi, in a glass plate contact toxicity test, Study No. APS-008-009. Adama Study No. 000110989.
Study date
3 April 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259111
Title
ADS-43: Effects on the Activity of Soil Microorganisms under Laboratory Conditions (Nitrogen Transformation Test). Study No. S22-00210/000110859.
Study date
19 February 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259300
Title
Microbial behaviour in salt-stressed ecosystems.
Study date
1994
Auth party contact address
-
Data no
259301
Title
Review. Osmosensing and osmoregulatory compatible solute accumulation by bacteria.
Study date
2001
Auth party contact address
-
Data no
259096
Title
Characterization of a Na Dependent Betaine Transporter With Cl- Channel Properties in Squid Motor Neurons.
Study date
1999
Auth party contact address
-
Data no
259097
Title
Temperature-induced changes in lipid biomarkers and mycosporine-like amino acids in the psychrophilic dinoagellate Peridinium aciculiferum.
Study date
2014
Auth party contact address
-
Data no
259098
Title
Evolutionary Analyses and Natural Selection of Betaine-Homocysteine S-Methyltransferase (BHMT) and BHMT2 Genes
Study date
2015
Auth party contact address
-
Data no
259093
Title
The Role of Organic Osmolytes in the Regulation of Mammalian Cell Volume.
Study date
1999
Auth party contact address
-
Data no
259084
Title
Osmoadaptation in Bacteria.
Study date
1995
Auth party contact address
-
Data no
259085
Title
Biochemical diversity of betaines in earthworms.
Study date
2013
Auth party contact address
-
Data no
259298
Title
ADS-43: Effects on the Reproduction of the Earthworm Eisenia fetida (Annelida, Lumbricidae) in Artificial Soil with 10 % Peat Study No. S22-00207/000110857.
Study date
19 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259092
Title
Predominant Osmotically Active Organic Solutes in Rat and Rabbit Renal Medulla.
Study date
1985
Auth party contact address
-
Data no
259013
Title
Mode of Action of ADS-43. ADAMA Chile report. . Adama Report No. 000111974.
Study date
2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259012
Title
Activating Natural Defence of Plants Elicitors and their Mode of Action.
Study date
2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259044
Title
Safety Data Sheets for non-active constituents
Study date
2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259034
Title
OECD Guidance Document on Botanical Active Substances Used in Plant Protection Products. Series on Pesticides, No. 90,
Study date
5 Apr 2017
Auth party contact address
-
Data no
259035
Title
PP 1/296 (1) Principles of efficacy evaluation for low-risk plant protection products.
Study date
2017
Auth party contact address
-
Data no
259304
Title
Permit Application. Biological or Plant Products (Non-standard goods)
Study date
25 August 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259305
Title
Actaban Bio Pre-application assistance (PAA) APVMA written assistance. PAA-1389089
Study date
16 February 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
271215
Title
Fermentation and Sensory evaluation of wines relating to the application of ADAMA ADS-43 to winegrapes
Study date
23 November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259036
Title
Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to an application concerning the use of betaine as a novel food in the EU.
Study date
22 February 2005
Auth party contact address
-
Data no
259037
Title
Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Trouw Nutritional International B.V.
Study date
2013
Auth party contact address
-
Data no
259038
Title
Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97.
Study date
2017
Auth party contact address
-
Data no
259039
Title
Safety and efficacy of betaine anhydrous for food-producing animal species based on a dossier submitted by AB Vista.
Study date
2018
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259040
Title
Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283. EFSA 2019.565, 8.
Study date
2019
Auth party contact address
-
Data no
259041
Title
Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA
Study date
2009
Auth party contact address
-
Data no
259091
Title
Methionine Metabolism in Mammals Distribution Homocysteine Between Competing Pathways.
Study date
1984
Auth party contact address
-
Data no
259121
Title
Effects of betaine supplementation on hepatic metabolism of sulfur-containing amino acids in mice.
Study date
2005
Auth party contact address
-
Data no
259115
Title
Pharmacokinetics of oral betaine in healthy subjects and patients with homocystinuria. 2003
Study date
2003
Auth party contact address
-
Data no
259120
Title
Glycine betaine rather than acting only as an osmolyte also plays a role as regulator in cellular metabolism.
Study date
2018
Auth party contact address
-
Data no
259083
Title
Occurrence of Choline and Glycine Betaine Uptake and Metabolism in the Family Rhizobiaceae and Their Roles in Osmoprotection.
Study date
1999
Auth party contact address
-
Data no
259063
Title
New approaches for extraction and determination of betaine from Beta vulgaris samples by hydrophilic interaction liquid chromatography-tandem mass spectrometry.
Study date
2017
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259062
Title
Concentrations of choline-containing compounds and betaine in common foods.
Study date
2003
Auth party contact address
-
Data no
259058
Title
Glycine betaine and glycine betaine analogues in common foods.
Study date
2003
Auth party contact address
-
Data no
259059
Title
Nutrient and heavy metal content of edible seaweed in New Zealand.
Study date
2010
Auth party contact address
-
Data no
259060
Title
Ueber das Betain, eine im Safte der Zucker- riiben (Beta vulgaris) vorkommende Pflanzenbase
Study date
2000
Auth party contact address
-
Data no
259061
Title
The clinical significance of betaine, an osmolyte with a key role in methyl group metabolism.
Study date
2010
Auth party contact address
-
Data no
259071
Title
ADS-43: Acute dermal toxicity study in Wistar rats (fixed dose procedure. Report No. G25180. Adama File No. 000110493.
Study date
28 October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259074
Title
Acute eye irritation/corrosion study in New Zealand white rabbits. Report No. G25183. Adama File No. 000110494.
Study date
14 September 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259072
Title
ADS-43: acute inhalation toxicity study in Wistar rats. Report No. G25181. Adama File No. 000110495.
Study date
21 October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259078
Title
ADS-43: In vitro mammalian cell micronucleus test in human peripheral blood lymphocytes including amendment No. 1 from 19 May 2023. Report No. G251864.
Study date
25 October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259079
Title
ADS-43: In vitro mammalian cell micronucleus test in human peripheral blood lymphocytes amendment No. 1 from 19 May 2023. Report No. G251864.
Study date
19 May 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259070
Title
ADS-43 Acute oral toxicity study (acute toxic class method) in Wistar rats. Report No. G25179. Adama File No. 000110496.
Study date
24 October 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259073
Title
ADS-43: Acute dermal irritation/corrosion study in New Zealand white rabbits. Report No. G25182. Adama File No. 000110500.
Study date
14 September 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259075
Title
ADS-43: Local lymph node assay (LLNA) in CBA/Ca mice including amendment No. 1 from 16 May 2023. Report No. G25184. Adama File No. 000110499.
Study date
21 November 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259076
Title
ADS-43: Local lymph node assay (LLNA) in CBA/Ca mice amendment No. 1 from. Report No. G25184. Adama File No. 000110499.
Study date
16 May 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259077
Title
ADS-43: Bacterial reverse mutation test. Report No. G25185. Adama File No. 000110497.
Study date
4 July 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259134
Title
Attenuation of heat stress-induced spermatogenesis complications by betaine in mice.
Study date
2018
Auth party contact address
-
Data no
259164
Title
Choline and betaine intake is inversely associated with breast cancer risk: A two-stage case-control study in China.
Study date
2013
Auth party contact address
-
Data no
259114
Title
EU/3/01/045: Orphan designation for the treatment of homocystinuria.
Study date
2007
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259064
Title
2011. Effects of betaine on body composition, performance, and homocysteine thiolactone.
Study date
2011
Auth party contact address
-
Data no
259081
Title
Toxicology Dossier DC2-94174481.
Study date
August 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259042
Title
EU/3/01/045: Orphan designation for the treatment of homocystinuria.
Study date
2007
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259080
Title
Characterization of the Percutaneous Absorption Of Betaine. Report No. 2007.02.04.
Study date
1 April 2008
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259065
Title
Effects of betaine on performance and body composition: a review of recent findings and potential mechanisms.
Study date
2014
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259066
Title
An Overview of Betaine Supplementation, Sports Performance and Body Composition.
Study date
2019
Auth party contact address
-
Data no
259067
Title
Dietary betaine intake is associated with skeletal muscle mass change over 3 years in middle-aged adults: the Guangzhou Nutrition and Health Study.
Study date
2021
Auth party contact address
-
Data no
259068
Title
Effects of short-term betaine supplementation on muscle endurance and indices of endocrine function following acute high-intensity resistance exercise in young athletes.
Study date
2022
Auth party contact address
-
Data no
259069
Title
Methionine kinetics in adult men: effects of dietary betaine on L-H3-methyl-1-13C]methionine.
Study date
1991
Auth party contact address
-
Data no
259119
Title
Betaine supplementation decreases plasma homocysteine concentrations but does not affect body weight, body composition, or resting energy expenditure in human subject.
Study date
2002
Auth party contact address
-
Data no
259116
Title
Orally. Administered Betaine Has an Acute and Dose-Dependent Effect on Serum Betaine and Plasma Homocysteine Concentrations in Healthy Humans.
Study date
2006
Auth party contact address
-
Data no
259117
Title
Elevated Tissue Betaine Contents in Developing Rats Are Due to Dietary Betaine, Not to Synthesis.
Study date
2008
Auth party contact address
-
Data no
259122
Title
Regulation of Hepatic Betaine-Homocysteine Methyltransferase by Dietary Betaine.
Study date
1983
Auth party contact address
-
Data no
259161
Title
Effect of high doses of folic acid supplementation in early pregnancy on child neurodevelopment at 18 months of age: the mother child cohort study in Crete, Greece.
Study date
2012
Auth party contact address
-
Data no
259162
Title
Choline and Betaine Intake and the Risk of Colorectal Cancer in Men.
Study date
2010
Auth party contact address
-
Data no
259137
Title
Increasing breast milk betaine modulates Akkermansia abundance in mammalian neonates and improves long-term metabolic health.
Study date
2021
Auth party contact address
-
Data no
259142
Title
Betaine Supplementation and Plasma Homocysteine in Healthy Volunteers.
Study date
2000
Auth party contact address
-
Data no
259143
Title
Low Dose Betaine Supplementation Leads to Immediate and Long Term Lowering of Plasma Homocysteine in Healthy Men and Women.
Study date
2003
Auth party contact address
-
Data no
259144
Title
Effect of Homocysteine-Lowering Nutrients on Blood Lipids: Results from Four Randomised, Placebo-Controlled Studies in Healthy Humans.
Study date
2005
Auth party contact address
-
Data no
259145
Title
Effect of Folic Acid and Betaine Supplementation on Flow-Mediated Dilation: A Randomized, Controlled Study in Healthy Volunteers.
Study date
2006
Auth party contact address
-
Data no
259146
Title
Betaine Supplementation Lowers Plasma Homocysteine in Healthy Men and Women.
Study date
2003
Auth party contact address
-
Data no
259147
Title
Dietary and supplementary betaine: Effects on betaine and homocysteine concentrations in males.
Study date
2009
Auth party contact address
-
Data no
259148
Title
Long-term effect of betaine on risk factors associated with the metabolic syndrome in healthy subjects.
Study date
2001
Auth party contact address
-
Data no
259149
Title
Effect of Dietary Betaine on Metabolic Syndrome Risk Factors in Asian Males with Mild Fatty Liver. , J
Study date
2016
Auth party contact address
-
Data no
259150
Title
Dietary choline and betaine intakes in relation to concentrations of inflammatory markers in healthy adults: the ATTICA study.
Study date
2008
Auth party contact address
-
Data no
259151
Title
Prospective study on dietary intakes of folate, betaine, and choline and cardiovascular disease risk in women.
Study date
2008
Auth party contact address
-
Data no
259152
Title
Plasma choline and betaine and risks of cardiovascular events and recurrent stroke after ischemic stroke.
Study date
2022
Auth party contact address
-
Data no
259153
Title
The Effects of Chronic Betaine Supplementation Oo Exercise Performance, Skeletal Muscle Oxygen Saturation and Associated Biochemical Parameters in Resistance Trained Men.
Study date
2011
Auth party contact address
-
Data no
259156
Title
Consequences of dietary methyl donor supplements: Is more always better.
Study date
2015
Auth party contact address
-
Data no
259157
Title
Autism Spectrum Disorders and Epigenetics.
Study date
2010
Auth party contact address
-
Data no
259158
Title
Reduced MeCP2 Expression is Frequent in Autism Frontal Cortex and Correlates with Aberrant MECP2 Promoter Methylation.
Study date
2006
Auth party contact address
-
Data no
259159
Title
Folic acid supplementation dysregulates gene expression in lymphoblastoid cells
Study date
2011
Auth party contact address
-
Data no
259160
Title
Genetic and Non-Genetic Influences during Pregnancy on Infant Global and Site Specific DNA Methylation: Role for Folate Gene Variants and Vitamin B12.
Study date
2012
Auth party contact address
-
Data no
259138
Title
Sex-biased transgenerational transmission of betaine-induced epigenetic modifications in glucocorticoid receptor gene and its down-stream BDNF/ERK pathway in rat hippocampus.
Study date
2022
Auth party contact address
-
Data no
259139
Title
Periconceptional Dietary Intake of Choline and Betaine and Neural Tube Defects in Offspring.
Study date
2021
Auth party contact address
-
Data no
259140
Title
Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice.
Study date
2021
Auth party contact address
-
Data no
259141
Title
Betaine Transport in Kidney and Liver: Use of Betaine in Liver Injury.
Study date
2013
Auth party contact address
-
Data no
259163
Title
Expression of fatty acid binding protein 4 is involved in the cell growth of oral squamous cell carcinoma.
Study date
2014
Auth party contact address
-
Data no
259165
Title
Betaine Supplementation for Various Clinical Disorders.
Study date
2017
Auth party contact address
-
Data no
259123
Title
Effect of acute betaine administration on hepatic metabolism of S-amino acids in rats and mice.
Study date
2003
Auth party contact address
-
Data no
259124
Title
Alleviation of Carbon-Tetrachloride-Induced Liver Injury and Fibrosis by Betaine Supplementation in Chickens.
Study date
2015
Auth party contact address
-
Data no
259125
Title
Dietary Betaine Addition Promotes Hepatic Cholesterol Synthesis, Bile Acid Conversion, and Export in Rats.
Study date
2020
Auth party contact address
-
Data no
259118
Title
Maternal betaine supplementation in rats induces intergenerational changes in hepatic IGF-1 expression and DNA methylation.
Study date
2017
Auth party contact address
-
Data no
259135
Title
Inhibition of NF-kB and the oxidative stress -dependent caspase-3 apoptotic pathway by betaine supplementation attenuates hepatic injury mediated by cisplatin in rats.
Study date
2019
Auth party contact address
-
Data no
259136
Title
The salutary action of melatonin and betaine, given singly or concomitantly, on cisplatin induced nephrotoxicity in mice.
Study date
2021
Auth party contact address
-
Data no
259127
Title
FTO-dependent function of N6-methyladenosine is involved in the hepatoprotective effects of betaine on adolescent mice
Study date
2015
Auth party contact address
-
Data no
259128
Title
Betaine chemistry, roles, and potential use in liver disease.
Study date
2016
Auth party contact address
-
Data no
259129
Title
Dietary Betaine and Fatty Acids Change Circulating.
Study date
2022
Auth party contact address
-
Data no
259130
Title
Betaine Supplementation to Rats Alleviates Disturbances Induced by High-Fat Diet: Pleiotropic Effects in Model of Type 2 Diabetes.
Study date
2021
Auth party contact address
-
Data no
259131
Title
Protective effects of betaine on diabetic induced disruption of the male mice blood-testis barrier by regulating oxidative stress-mediated p38 MAPK pathways.
Study date
2018
Auth party contact address
-
Data no
259132
Title
Betaine supplementation improves the atherogenic risk factor prole in a transgenic mouse model of hyperhomocysteinemia.
Study date
2007
Auth party contact address
-
Data no
259133
Title
Enhanced hepatic cholesterol accumulation induced by maternal betaine exposure is associated with hypermethylation of CYP7A1 gene promoter. Published online 28 March 2019.
Study date
2019
Auth party contact address
-
Data no
259126
Title
Betaine in sub-acute and sub-chronic rat studies.
Study date
2003
Auth party contact address
-
Data no
259095
Title
Adaptions with Respect to Salinity.
Study date
1976
Auth party contact address
-
Data no
259099
Title
Betaines in higher plants - biosynthesis and role in stress metabolism. Amino Acids and their Derivatives in Higher Plants. pp. 173 - 204
Study date
1995
Auth party contact address
-
Data no
259302
Title
Beet Extract_ Actavan Bio Environment Dossier. DC2-941744881.
Study date
August 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259303
Title
Validation of the detection and quantification of trimethyl glycine in water and 50 percent sucrose solution. Amended report APIS, Wath, Ripon, UK, report no. APIS-008-008, ADAMA file no. 000109522.
Study date
31 March 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259086
Title
Living with Water Stress: Evolution of Osmolyte Systems.
Study date
1982
Auth party contact address
-
Data no
259087
Title
Quaternary ammonium compounds can be abundant in some soils and are taken up as intact molecules by plants.
Study date
2013
Auth party contact address
-
Data no
259082
Title
Quaternary Ammonium and Tertiary Sulfonium Compounds In Higher Plants.
Study date
1993
Auth party contact address
-
Date
Application Date
Application No
Application Number
141311
Product/Active constituent Name
Application Product Name
Pinoxaden manufacturing concentrate
Application Date
Application Number
141311
Application Product Name
Pinoxaden manufacturing concentrate
Application details
Product name:
Pinoxaden manufacturing concentrate
Active name:
Pinoxaden manufacturing concentrate
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of pinoxaden manufacturing concentrate for use in agricultural chemical products.
Description of data provided:
Data no
258701
Title
A23833A- SF-1141/1- Determination of NOA407855 in A23833A by HPLC Methodology
Study date
12 October 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258702
Title
A23833A- SB-1141/1- Determination of NOA407854 and SYN523243 in A23833A by HPLC Methodology
Study date
10 November 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258703
Title
A23833A- SB-1142/1- Determination of Toluene and Methyl Cyclohexane in A23833A by Gas Chromatography
Study date
15 November 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258704
Title
A23833A- SB-1143/1- Determination of CGA42685 in A23833A by Liquid Chromatography by Methodology
Study date
21 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258705
Title
A23833A - Validation of Analytical Method SF-1141/1
Study date
25 January 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258706
Title
A23833A - Validation of Analytical Method SB-1141/1
Study date
28 February 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258707
Title
A23833A - Validation of Analytical Method SB-1142/1
Study date
04 April 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258708
Title
A23833A - Validation of Analytical Method SB-1143/1
Study date
01 June 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
273238
Title
A23833A - SFA-1141/1 - Determination of Hexylene Glycol (CA106) in Pinoxaden MUP (A23833A) by Gas Chromatography
Study date
02 December 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
273239
Title
A23833A - Validation of Analytical Method SFA-1141/1
Study date
02 December 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
279225
Title
Pinoxaden TK (25) ? Analysis of Five Representative Batches
Study date
10 October 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258700
Title
A23833A - Analysis of Five Representative Batches
Study date
18 July 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
279226
Title
Pinoxaden manufacturing concentrate - Declaration of Composition
Study date
15 October 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
279227
Title
Pinoxaden manufacturing concentrate (94037/141311) - Response to Regulation 8AHAA
Study date
15 October 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
279228
Title
Pinoxaden technical (AC No. 59021) - Declaration of Composition
Study date
15 October 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
273240
Title
Response to s159 Notice
Study date
05 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
273241
Title
NOA407855A Typical Spectra Report Amendment 1
Study date
03 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
273242
Title
Declaration of Composition
Study date
04 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
273243
Title
Statement on the concentration of NOA407854 and CGA42685 in the pinoxaden manufacturing concentrate
Study date
02 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258690
Title
Part 2 - Chemistry and Manufacture
Study date
04 September 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258691
Title
A23833A - Typical Pinoxaden Spectra of Five Representative Batches
Study date
18 July 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258692
Title
NOA407855A Typical Spectra
Study date
25 January 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258693
Title
Safety Data Sheets
Study date
17 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258694
Title
A23833A - Physical and Technical Properties of Batch 1252591
Study date
20 October 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258695
Title
A23833A ??? Physico-chemical characteristics of Batch 1252591
Study date
20 October 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258696
Title
A23833A - Safety Study
Study date
14 February 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258697
Title
A23833A - Oxidation/Reduction: Chemical Incompatibility
Study date
14 February 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258698
Title
A23833A - Storage Stability and Shelf Life Statement (2 weeks at 54??C) in Stainless Steel according to CIPAC MT 46.4
Study date
10 November 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258699
Title
A23833A - Storage Stability and Shelf Life Statement (2 weeks at 54??C) in HDPE according to CIPAC MT 46.4
Study date
4 November 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258714
Title
Pinoxaden TK (A23833A) ??? In Vitro Eye Irritation Test in Isolated Chicken Eyes
Study date
03 November 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258715
Title
Pinoxaden TK (A23833A) - Acute Eye Irritation Study in Rabbits
Study date
26 January 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258711
Title
Pinoxaden TK (A23833A) - Acute Inhalation Toxicity Study in Rats
Study date
1 February 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258710
Title
Pinoxaden TK (A23833A) ??? Acute Oral Toxicity Study in Rats (Up and Down Procedure)
Study date
10 December 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258712
Title
Pinoxaden TK (A23833A) ??? In Vitro Skin Irritation Test in the EPISKIN??? Model
Study date
03 November 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258713
Title
Pinoxaden TK (A23833A) - Primary Skin Irritation Study in Rabbits
Study date
02 November 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258716
Title
Pinoxaden TK (A23833A) - Local Lymph Node Assay (LLNA) in Mice
Study date
28 January 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258717
Title
Toxicological Database - Pinoxaden
Study date
17 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
258709
Title
Part 3 - Toxicology
Study date
17 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
141308
Product/Active constituent Name
Application Product Name
Telbek Adavelt active Fungicide
Application Date
Application Number
141308
Application Product Name
Telbek Adavelt active Fungicide
Application details
Product name:
Telbek Adavelt active Fungicide
Product number:
88999
Applicant Name:
CORTEVA AGRISCIENCE AUSTRALIA PTY LTD
Application purpose and description of use:
To update the formulation composition
Active constituents:
Active constituent name
88998 - Florylpicoxamid
Description of data provided:
Data no
258684
Title
Part 2: Chemistry & Manufacture
Study date
5 September 2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
258688
Title
Telbek SDS
Study date
Sep 2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
258685
Title
GF-3840 Two Week 54??C Accelerated Storage Stability in PET, EVOH, and COEX Packaging and One Week 0??C Low Temperature Stability
Study date
08-October-2019
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
258686
Title
G1C-1-185 Two Week 54??? Accelerated Storage Stability in F-HDPE
Study date
28-June-2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
258687
Title
Part 8: Efficacy & Crop Safety
Study date
August 2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
258689
Title
Cover Letter
Study date
2023
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
273237
Title
Response to s159
Study date
2024
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Date
Application Date
Application No
Application Number
141213
Product/Active constituent Name
Application Product Name
Glysmart 600 Herbicide
Application Date
Application Number
141213
Application Product Name
Glysmart 600 Herbicide
Application details
Product name:
Glysmart 600 Herbicide
Product number:
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
Reference details:
82715 - Glymount 540K Herbicide
Active constituents:
Active constituent name
63383 - GLYPHOSATE
Active constituent name
64304 - GLYPHOSATE
Description of data provided:
Data no
258454
Title
C of A for active
Study date
August 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258455
Title
Safety Data Sheets
Study date
August 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
272339
Title
Certificate of Analysis
Study date
23 June 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258453
Title
Part 2 - Chemistry and Manufacture
Study date
August 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
272338
Title
Glysmart 600 Herbicide formulation revision 290524
Study date
29 May 2024
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258456
Title
Determination of the Physical-chemical properties of Glyphosate 600 SL formulation
Study date
25 May 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258458
Title
Part 8 - Efficacy
Study date
June 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258459
Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW Report No: GLYSMART600-BIOEQ- 2023-01
Study date
15 May 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258460
Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW GLYSMART600-BIOEQ- 2023-02
Study date
16 May 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258461
Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW GLYSMART600-BIOEQ- 2023-03
Study date
17 May 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258462
Title
BIOEQUIVALENCE OF GLYSMART 600 +/- TERWET 3780 AND GLYSOWET FOR FALLOW WEED CONTROL GLYSMART600-BIOEQ-TERWETT-2023_2
Study date
14 May 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258463
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
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258464
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
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258465
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
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258466
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
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258467
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
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Data no
258457
Title
Executive Summary
Study date
25 August 2023
Auth party contact address
113 FITZROY STREET TAMWORTH Australia
Date
Application Date
Application No
Application Number
141351
Product/Active constituent Name
Application Product Name
Sugar beet
Application Date
Application Number
141351
Application Product Name
Sugar beet
Application details
Product name:
Sugar beet
Product number:
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
259217
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
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259229
Title
Methodology information. Amended letter. Report no. 1426B
Study date
26 June 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259230
Title
ADS-43. Document M-CP, Section 5. Analytical Methods.
Study date
July 2023.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259218
Title
Two batch analysis of trimethylglycine in beet extract samples. Report no. S22- 06525, ADAMA file report 000111862
Study date
16 September 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259219
Title
Analysis of trimethylglycine in two batches of beet extract. Report no. S23- 101874, ADAMA file report 00011
Study date
30 May 2023.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259220
Title
Analysis report 22006103-02-1 beet extract. Chemical results free amino acids. Report no. 22006103-02
Study date
2 November 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259223
Title
Analysis report 22006104-02-1 beet extract. Pyrrolizidine alkaloids. report no. 22006104-01-2
Study date
7 November 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259224
Title
Analysis report 22006105-02-1 beet extract. Tropane alkaloids. Report no. 22006105-01-2
Study date
7 November 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259225
Title
Analysis report 22006106-03-1 beet extract. Hydroxymethylfurfural HMF. Report no. 22006106-03-1
Study date
15 November 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259226
Title
Analysis Pyrrolizidine Tropane alkaloids. Report 23003358-02-2
Study date
29 July 2023.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259227
Title
Analysis report 23003358-01-1 beet extract. Acylamide and hydroxymethylfurfural. Report no. 23003358-01-1
Study date
17 July 2023.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259228
Title
Analysis of the Composition Fingerprint of Four Batches of Beet Extract. Report No. S23-104968
Study date
27 July 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259204
Title
Sample overview: Sugar beet extract (raw ingredient). Waikaitu Ltd., Tasman, New Zealand, 16 February 2022
Study date
16 February 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259205
Title
Sample overview part 2: Sugar beet extract (raw ingredient) Waikaitu Ltd., Tasman, New Zealand,
Study date
19 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259208
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 921895
Study date
12 January 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259210
Title
Certificate of Analysis. Cawthron Analytical Science, Nelson, New Zealand; report no. 941026
Study date
2 May 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259211
Title
Certificate of Analysis. Cawthron Analytical Science, Nelson, New Zealand; report no. 864603
Study date
26 Jan 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259213
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 938445
Study date
27 April 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259214
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 976076
Study date
21 December 2021.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259215
Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 989894
Study date
30 March 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259216
Title
Certificate of Analysis. Amended. Cawthron Analytical Science, Nelson
Study date
7 July 2023.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259212
Title
Statement on internal and external molasses labelling. Identification BT210122.
Study date
6 March 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259209
Title
Analysis of sugar beet molasses. Statement identification number GB201016-19
Study date
20 April 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259206
Title
Non-GMO Certificate R141703 Results of inspection.
Study date
28 August 2017
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259207
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
Auth party contact address
-
Data no
259199
Title
HANDBOOK OF Aqueous Solubility Data. SECOND EDITION. 2010 CEC Pres Taylor & Francis Group.
Study date
2010
Auth party contact address
-
Data no
259200
Title
Dioxins and furans content in 1` batch of beet extract. Report No. AR-22-NC-009555-01.
Study date
27 April 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259201
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
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259202
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
Auth party contact address
-
Data no
259203
Title
Russian Federation. Sugar sector review. FAO Investment Centre, Rome 2013
Study date
2013
Auth party contact address
-
Data no
259221
Title
Certificate of Accreditation. Cawthron Institute, Accreditation no. 107, 12 May 2022
Study date
12 May 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259222
Title
Akkreditierung Deutsche Akkreditierungsstelle GmbH. Institut Kurz GmbH. Certificate no. D-PL-14140-01-00
Study date
14 December 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
259198
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.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
140895
Product/Active constituent Name
Application Product Name
Molidustat
Application Date
Application Number
140895
Application Product Name
Molidustat
Application details
Product name:
Molidustat
Product number:
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.
Date
Application Date
Application No
Application Number
140896
Product/Active constituent Name
Application Product Name
Varenzin Oral Solution for Cats
Application Date
Application Number
140896
Application Product Name
Varenzin Oral Solution for Cats
Application details
Product name:
Varenzin Oral Solution for Cats
Product number:
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.
Active constituents:
Active constituent name
94656 - Molidustat sodium
Description of data provided:
Data no
266606
Title
Apx 2-6: API specification
Study date
April 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266620
Title
Apx 2-20: Analytical method
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266621
Title
Apx 2-21: Validation
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271104
Title
3.2.P.3.5 Validation
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266615
Title
Apx 2-15: Batch analysis
Study date
January 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266612
Title
Apx 2-12: Batch formula
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271100
Title
3.2.P.2.3 - Manufacturing process development
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266608
Title
Apx 2-8: Manufacturers
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266609
Title
Apx 2-9: GMP certificate
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266610
Title
Apx 2-10: Manufacturing
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266611
Title
Apx 2-11: Control critical steps
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257801
Title
GMP Evidence
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266607
Title
Apx 2-7: Certificates of analysis
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266602
Title
Apx 2-1: Pre-application Assistance ? APVMA Written Advice: 138256
Study date
27/2/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266622
Title
Apx 2-2: Pre-applicaiton Assistance ? APVMA Written Advice: 138935
Study date
8/5/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271098
Title
3.2.P.2.1 - Pharmaceutical development
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271099
Title
3.2.P.2.2 - Formulation development
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271105
Title
3.2.P.5.3 Forced degradation study
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281466
Title
GMP Certificate
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271101
Title
3.2.P.2.4 Container system
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271102
Title
3.2.P.2.5 - Microbiological attributes
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
271103
Title
3.2.P.2.6 - Compatabilty
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266613
Title
Apx 2-13: Specifications
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266614
Title
Apx 2-14: Product specifications
Study date
November 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266605
Title
Apx 2-5: Formulation
Study date
June 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266616
Title
Apx 2-16: Stabilty
Study date
December 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266617
Title
Apx 2-17: Stabilty
Study date
December 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266618
Title
Apx 2-18: Stablity
Study date
January 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266619
Title
Apx 2-19: Stablity
Study date
December 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264973
Title
Ref 52 - Dose determination study
Study date
14/12/2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264974
Title
Ref 53 - Dose determination study
Study date
19/4/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264975
Title
Ref 54 - Dose determination
Study date
16/12/2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264976
Title
Ref 55 - dose confirmation
Study date
23/4/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264977
Title
Ref 56 - dose confirmation
Study date
20/9/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264978
Title
Ref 57 - Field study
Study date
1/11/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264979
Title
Ref 58 - Palatability study
Study date
9/5/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264980
Title
Ref 59 - Palatability study
Study date
23/10/2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264961
Title
Ref 40 - Discovery of Molidustat (BAY 85-3934): A Small-Molecule Oral HIF-Prolyl Hydroxylase (HIF-PH) Inhibitor for the Treatment of Renal Anaemia.
Study date
2017
Auth party contact address
-
Data no
264968
Title
Ref 47 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264959
Title
Ref 38 - Structure of an HIF-1 alpha ? pVHL Complex: Hydroxyproline Recognition in Signaling
Study date
2001
Auth party contact address
-
Data no
264955
Title
Ref 34 - Molecular basis of hypoxia-induced erythropoietin expression
Study date
1996
Auth party contact address
-
Data no
264956
Title
Ref 35 - Regulated oxygen sensing by protein hydroxylation in renal erythropoietin-producing cells
Study date
2010
Auth party contact address
-
Data no
264957
Title
Ref 36 - A Conserved Family of Prolyl-4-Hydroxylases That Modify HIF.
Study date
2001
Auth party contact address
-
Data no
281467
Title
Expert Statement
Study date
2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281468
Title
Expert statement
Study date
2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281469
Title
The use of erythropoietin
Study date
2003
Auth party contact address
-
Data no
281470
Title
Survival in Cats with Naturally Occurring Chronic Kidney Disease
Study date
2008
Auth party contact address
-
Data no
281471
Title
IRIS Staging of CKD
Study date
2023
Auth party contact address
-
Data no
281472
Title
PV data
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281473
Title
Feline Nonregenerative Anaemia:
Pathophysiology and Etiologies
Pathophysiology and Etiologies
Study date
2009
Auth party contact address
-
Data no
264982
Title
Ref 33 - Hypoxia-Inducible Factors in Physiology and Medicine. Cell.
Study date
2012
Auth party contact address
-
Data no
264965
Title
Ref 44 - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2012). Guidance on Photosafety evaluation of pharmaceuticals.
Study date
2012
Auth party contact address
-
Data no
266138
Title
Part 8 Efficacy & Safety summary
Study date
December 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264966
Title
Ref 45 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264967
Title
Ref 46 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264983
Title
Ref 27 - PK formulation comparison
Study date
8/2/2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264984
Title
Ref 5 - PK study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281474
Title
Effect of API on Plasma levels
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264958
Title
Ref 37 - C. elegans EGL-9 and Mammalian Homologs Define a Family of Dioxygenases that Regulate HIF by Prolyl Hydroxylation.
Study date
2001
Auth party contact address
-
Data no
264960
Title
Ref 39 - Oxygen sensing by HIF hydroxylases.
Study date
2004
Auth party contact address
-
Data no
264928
Title
Ref 4 - PK Study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264929
Title
Ref 6 - PK study
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264930
Title
Ref 7 - PK study
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264931
Title
Ref 8 - PK study
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264932
Title
Ref 9 - PK study
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264933
Title
Ref 10 - PK study
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264934
Title
Ref 11 - PK study
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264969
Title
Ref 48 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264970
Title
Ref 49 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264971
Title
Ref 50 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264972
Title
Ref 51 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264962
Title
Ref 41 - PD study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264963
Title
Ref 42 - PD study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264964
Title
Ref 43 - PD study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264937
Title
Ref 14 - PK study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264938
Title
Ref 15 - PK study
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264939
Title
Ref 16 - PK study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264940
Title
Ref 17 - PK study
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264941
Title
Ref 18 - PK study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264942
Title
Ref 19 - PK study
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264943
Title
Ref 20 - PK study
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264944
Title
Ref 21 - PK study
Study date
2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264945
Title
Ref 22 - PK study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264946
Title
Ref 23 - PK study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264947
Title
Ref 24 - PK study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264948
Title
Ref 25 - PK study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264949
Title
Ref 26 - PK study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264950
Title
Ref 28 - PK study
Study date
18/10/2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264951
Title
Ref 29 - PK study
Study date
29/10/2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264952
Title
Ref 30 - PK study
Study date
13/4/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264953
Title
Ref 31 - PK study
Study date
14/4/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264954
Title
Ref 32 - PK study
Study date
15/4/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257285
Title
Report 44240a - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257286
Title
Report 44240b - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257287
Title
Report 44240c - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257288
Title
Report 44240d - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257289
Title
Report 44240e - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257290
Title
Report 44240a (D) - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257291
Title
Report 44240b (D) - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257292
Title
Report 44240c (D) - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257293
Title
Report 44240d (D) - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257294
Title
Report 44240e (D) - TAS
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264981
Title
Ref 60 - Safety study
Study date
4/5/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264936
Title
Ref 13 - TAS study
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261955
Title
Environmental Risk assessment
Study date
22/6/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264927
Title
Ref 1 - PAA 138256
Study date
27/2/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257295
Title
Ref 2 - Project plan
Study date
1 August 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264985
Title
Ref 2 - PAA 138935
Study date
8/5/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264986
Title
Ref 3 - Project plan
Study date
1/8/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266603
Title
Apx 2-3: Project plan
Study date
27/7/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
266604
Title
Apx 2-4: Email communication between Registrant/APVMA
Study date
11/12/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
281475
Title
s159 response
Study date
21 November 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257308
Title
Report 45163 - Dermal absorption study
Study date
2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257309
Title
Report 45163 (D) - Dermal absorption study
Study date
2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257310
Title
Report 46355 - Ocular irritation study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257311
Title
Report 46296 - Ocular irritation study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257312
Title
Report 46296 (D) - Ocular irritation study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257313
Title
Report 38889 - Oral toxicology
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257317
Title
Report 38887 - Oral toxicology
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257318
Title
Report 44082 - Oral and intravenous toxicology
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257320
Title
Report 44087 - Oral and iv toxicology
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257322
Title
Report 48019 - Oral and iv toxicology
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257325
Title
38884 (D) - toxicology additonal data
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257326
Title
Report 38895 (D) - Acute toxicity
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257328
Title
Report 38886 (D) - Oral toxicology
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257330
Title
Report 38883 (D)- Oral toxicology
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257354
Title
Report 44313 - Critical evaluation genotoxicity
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257332
Title
Report 46355 (D) - Ocular irritation study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257333
Title
Report 46287 (D) - Skin sensitization study
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257334
Title
Report 46315 (D) - Skin irritation study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257335
Title
Report 46315 - Skin irritation study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257336
Title
Report 46320 - Skin sensitization study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257337
Title
Report 46287 - Skin sensitization study
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257338
Title
Report 46320 (D) - Skin sensitization study
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257341
Title
Report 46913 (D) - Carcinogenicity study rats
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257342
Title
Report 46939 (D) - Carcinogenicity study mice
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257343
Title
Report 46941 (D) - Developmental study rats
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257344
Title
Report 38905 - Developmental study rats
Study date
2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257345
Title
Report 38906 - Developmental study rats
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257347
Title
Report 46940 - Developmental study rats
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257348
Title
Report 46941 - Developmental study rats
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257349
Title
Report 46940 (D) Developmental study rats
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257351
Title
Report 38905 (D) - Developmental study rats
Study date
2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257352
Title
Report 38906 (D) - Developmental study rats
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257353
Title
Report 38907 (D) - Developmental study rabbits
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257355
Title
Hypoxia-Inducible Factors in Physiology and Medicine
Study date
2012
Auth party contact address
-
Data no
257356
Title
Molecular basis of hypoxia-induced erythropoietin expression.
Study date
1996
Auth party contact address
-
Data no
257357
Title
Regulated oxygen sensing by protein hydroxylation in renal erythropoietin-producing cells.
Study date
2010
Auth party contact address
-
Data no
257358
Title
A Conserved Family of Prolyl-4-Hydroxylases That Modify HIF.
Study date
2001
Auth party contact address
-
Data no
257359
Title
C. elegans EGL-9 and Mammalian Homologs Define a Family of Dioxygenases that Regulate HIF by Prolyl Hydroxylation.
Study date
2001
Auth party contact address
-
Data no
257360
Title
Structure of a HIF-1??-pVHL Complex: Hydroxyproline Recognition in Signaling.
Study date
2001
Auth party contact address
-
Data no
257361
Title
Oxygen sensing by HIF hydroxylases.
Study date
2004
Auth party contact address
-
Data no
257362
Title
Ref 8 Toxicology other information
Study date
2017
Auth party contact address
-
Data no
257363
Title
Report PH36104 - toxicology other information
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257364
Title
Report 46937 - toxicology other information
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257365
Title
Report 46938 - toxicology other in
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257366
Title
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Study date
2012
Auth party contact address
-
Data no
257368
Title
Report 38885 - toxicology additional data
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257370
Title
Report 44091 - Toxicology additional information
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257372
Title
FDA. (2007). Summary basis for approval of Mircera (BLA 125164).Pharmacology reviews a,b
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257373
Title
Excessive erythrocytosis in adult mice overexpressing erythropoietin leads to hepatic, renal, neuronal, and muscular degeneration
Study date
2006
Auth party contact address
-
Data no
257374
Title
Reduced cerebral blood flow but elevated cerebral glucose metabolic rate in erythropoietin overexpressing transgenic mice with excessive erythrocytosis
Study date
2007
Auth party contact address
-
Data no
257381
Title
Effect of erythroietin on the micronucleus test.
Study date
1989
Auth party contact address
-
Data no
257382
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
Auth party contact address
-
Data no
257383
Title
Genotoxicity of genetic recombinant human erythropoietin in a novel test system
Study date
1993
Auth party contact address
-
Data no
257385
Title
Induction of micronucleated erythrocytes by recombinant human erythropoietin
Study date
1993
Auth party contact address
-
Data no
257386
Title
Prior bleeding enhances the sensitivity of the in vivo micronucleus test
Study date
1991
Auth party contact address
-
Data no
257387
Title
Evaluation of nongenotoxic and genotoxic factors modulating the frequency of micronucleated erythrocytes in the peripheral blood of mice
Study date
1985
Auth party contact address
-
Data no
257389
Title
Report 38899 - Phototoxicity assay
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257390
Title
EFSA, 2012. Scientific opinion on the re- evaluation of butylated hydroxytoluene BHT (E 321) as a food additive.
Study date
2012
Auth party contact address
-
Data no
257391
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
Auth party contact address
-
Data no
257392
Title
Report 46790 - Investigators Brochure API
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257393
Title
Report 38890 (D) - Forward cell mutation
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257394
Title
Report 46937 (D) - toxicology additional data
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257395
Title
46938 (D) - toxicology additional data
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257396
Title
Retinopathy of Prematurity: Current concepts in Molecular Pathogenesis
Study date
2009
Auth party contact address
-
Data no
257397
Title
Report 38892 (D) - Salmonella/Microsome test
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257398
Title
Report 38893 (D) - DNA synthesis rat liver
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257399
Title
Report 38891 (D) - Micronucleus test - mice
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257400
Title
Report 38894 (D) - Cytogenetic study mice
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257402
Title
Report 46790 (D) - Investigators Brochure API
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257403
Title
Von Hipple- Lindau protein in the RPE is essential for normal ocular growth and vascular development.
Study date
2012
Auth party contact address
-
Data no
257404
Title
APVMA Part 3 Toxicology Overview
Study date
1 August 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257296
Title
Report 48239 - Plasma protein binding various species
Study date
2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257297
Title
Report 44112 -Plasma protein binding various species
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257300
Title
Report PH-37906 - Metabolism lab animal
Study date
2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257303
Title
Report PH-39762 - Metabolism other
Study date
2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257306
Title
Report 46687 - PK study formulation
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257307
Title
Ref 36 - Metabolism other information
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
264935
Title
Ref 12 - Safety/toxicology summary
Study date
26/7/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257410
Title
Report 38888 (D) - Short term study dogs
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257411
Title
Report 38900 (D) - Short term lab animal
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257412
Title
Report 38896 (D) - Short term oral lab animal
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257413
Title
EFSA 2017. Re- evaluation of mono- and diglycerides of fatty acids (E471) as food additives
Study date
2017
Auth party contact address
-
Data no
257416
Title
Report 38901b - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257417
Title
Report 38901c - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257418
Title
Report 38901d - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257419
Title
Report 38901e - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257420
Title
Report 38901f - Sub-chronic oral lab animal
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257425
Title
Report 38904 - Sub-chronic study dogs
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257426
Title
Report 38897 (D) - Sub-chronic study dogs
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257429
Title
Report 38902 (D) - Sub-chronic study lab animal
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257430
Title
Report 38901a (D) - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257431
Title
Report 38901b (D) - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257432
Title
Report 38901c (D) - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257433
Title
Report 38901d (D) - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257434
Title
Report 38901e (D) - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257435
Title
Report 38901f (D) - Sub-chronic oral lab animals
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257436
Title
Report 38903a (D) - Sub-chronic oral lab animal
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
257437
Title
Report 38903b (D) - Sub-chronic oral lab animal
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283810
Title
Report 38898 (D) - Sub-chronic study dogs
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
141088
Product/Active constituent Name
Application Product Name
Trifloxystrobin
Application Date
Application Number
141088
Application Product Name
Trifloxystrobin
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
257626
Title
Determination of Active Content and Impurity Profile of Trifloxystrobin
Study date
April 2020
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257629
Title
Analysis of active ingredient Trifloxystrobin by HPLC-UV
Study date
June 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257631
Title
Statement of 5 Batch Size and Typical Batch Size of Trifloxystrobin Technical
Study date
July 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257627
Title
Trifloxystrobin Technical Manufacture process
Study date
July 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
276687
Title
Trifloxystrobin Technical Manufacture Process Optimization
-Impurity ARS1892 Control Instruction
-Impurity ARS1892 Control Instruction
Study date
May 2024
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
276688
Title
Certificate of analysis
Study date
January 2024
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257628
Title
Declartion of composition
Study date
August 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257630
Title
Packing Specification of Trifloxystrobin Technical
Study date
July 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257632
Title
Material Safety Data Sheet
Study date
July 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
257633
Title
Explanation letter for the change of name
Study date
May 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
276689
Title
Letter of November 10, 2022, confirming the equivalence of the technical material of the active substance trifloxystrobin. (Polish transcript)
Study date
April 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
276690
Title
Letter of November 10, 2022, confirming the equivalence of the technical material of the active substance trifloxystrobin. (English translation of TR1002 transcript)
Study date
April 2023
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore
Data no
276691
Title
Mammalian erythrocyte micronucleus test of Trifloxystrobin TC in rats
Study date
September 2021
Auth party contact address
10 Anson Road #11-20 International Plaza SINGAPORE Singapore