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
152728
Product/Active constituent Name
Application Product Name
Bob Martin 3 in 1 Spot On for Dogs 10-25kg
Application Date
Application Number
152728
Application Product Name
Bob Martin 3 in 1 Spot On for Dogs 10-25kg
Application details
Product name:
Bob Martin 3 in 1 Spot On for Dogs 10-25kg
Applicant Name:
BOB MARTIN (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 100g/L imidacloprid and 25g/L moxidectin topical solution/suspension product for treatment of topical flea and worm.
Date
Application Date
Application No
Application Number
152730
Product/Active constituent Name
Application Product Name
Bob Martin 3 in 1 Spot On for Dogs over 25kg
Application Date
Application Number
152730
Application Product Name
Bob Martin 3 in 1 Spot On for Dogs over 25kg
Application details
Product name:
Bob Martin 3 in 1 Spot On for Dogs over 25kg
Applicant Name:
BOB MARTIN (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 100g/L imidacloprid and 25g/L moxidectin topical solution/suspension product for treatment of topical flea and worm.
Date
Application Date
Application No
Application Number
152757
Product/Active constituent Name
Application Product Name
The Mosquito & Midge Outdoor Barrier Hose-On Professional Mosquito Outdoor Solution
Application Date
Application Number
152757
Application Product Name
The Mosquito & Midge Outdoor Barrier Hose-On Professional Mosquito Outdoor Solution
Application details
Product name:
The Mosquito & Midge Outdoor Barrier Hose-On Professional Mosquito Outdoor Solution
Applicant Name:
VECTORA AUSTRALIS PTY LTD
Application purpose and description of use:
Registration of a 25 g/L bifenthrin suspension concentrate product for the control of adult mosquitoes and midges.
Date
Application Date
Application No
Application Number
152814
Product/Active constituent Name
Application Product Name
difenoconazole
Application Date
Application Number
152814
Application Product Name
difenoconazole
Application details
Product name:
difenoconazole
Active name:
difenoconazole
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Approval of difenoconazole for use in agricultural chemical products
Description of data provided:
Data no
305387
Title
Safety Data Sheets Difenoconazole Technical
Study date
2026
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305390
Title
Composition Certificate Difenoconazole
Study date
April 2026
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305393
Title
Difenoconazole Technical Analysis of active ingredient and impurities in one batch
Study date
22 July 2025
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305388
Title
Manufacturing Process Difenoconazole
Study date
2026
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305391
Title
Difenoconazole TC-Analysis of active ingredient and impurities in five batches
Study date
21 August 2021
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305389
Title
Difenoconazole Declaration of Composition
Study date
April 2026
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305392
Title
Certificate of Analysis
Study date
19 May 2025
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
305386
Title
DC24-79194699 - Item 24 Module 2.2 Chemistry and Manufacture
Study date
April 2026
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
152864
Product/Active constituent Name
Application Product Name
Fluroxypyr-meptyl
Application Date
Application Number
152864
Application Product Name
Fluroxypyr-meptyl
Application details
Product name:
Fluroxypyr-meptyl
Active name:
Fluroxypyr-meptyl
Applicant Name:
WEIFANG NUCHLOR CHEMICAL CO., LTD.
Application purpose and description of use:
Approval of Fluroxypyr-Meptyl for use in agricultural chemical products.
Description of data provided:
Data no
305676
Title
Declaration of Composition of Fluroxypyr-meptyl Technical
Study date
2024/12/12
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
305679
Title
Impurity Justification of Fluroxypyr-meptyl Technical
Study date
2024/12/12
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
305680
Title
The Statement of Batch Size of Fluroxypyr-meptyl Technical
in 5-Batch Report
in 5-Batch Report
Study date
2023/3/15
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
305677
Title
Manufacture Process of Fluroxypyr-meptyl Technical
Study date
2024/12/12
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
305678
Title
4 Registration Data of Fluroxypyr-meptyl Technical
Study date
2024/12/12
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
305675
Title
Qualitative and Quantitative Profile of Fluroxypyr-meptyl Technical (Five Batch Analysis)
Study date
15/Jun/2021
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Date
Application Date
Application No
Application Number
152923
Product/Active constituent Name
Application Product Name
BOLLGARD 3
Application Date
Application Number
152923
Application Product Name
BOLLGARD 3
Application details
Product name:
BOLLGARD 3
Product number:
69656
Applicant Name:
MONSANTO AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to amend the Resistance Management Plan
Description of data provided:
Data no
305564
Title
Correspondence on proposed change to RMP
Study date
2025-06-13
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
305565
Title
Resistance Management Plan for Bollgard 3 Cotton for Southern Australia - marked-up version
Study date
2026-04-16
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
305566
Title
Resistance Management Plan for Bollgard 3 Cotton for Southern Australia
Study date
2016-04-16
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Date
Application Date
Application No
Application Number
153002
Product/Active constituent Name
Application Product Name
IMIDACLOPRID
Application Date
Application Number
153002
Application Product Name
IMIDACLOPRID
Application details
Product name:
IMIDACLOPRID
Active name:
IMIDACLOPRID
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Approval of imidacloprid for use in agricultural chemical products.
Description of data provided:
Data no
305562
Title
Five Batches Analysis of Imidacloprid 97 % Technical 30 October 2025 Shandong Hailir Chemical Co., Ltd Study Number 25P459S04. M-894180-01-1
Study date
2025-10-30
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
305560
Title
Certificate of Composition Imidacloprid Technical Material for Australia M-893971-02-1
Study date
2026-03-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
305563
Title
IMIDACLOPRID Item 17 - Application for approval of a new source of an agricultural active constituent DC17-47607585
Study date
2026/04/17
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
305561
Title
Shandong Hailir Chemical Co., Ltd. The Synthesis and Impurities Description of Imidacloprid Technical M-894176-01-1
Study date
2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
153051
Product/Active constituent Name
Application Product Name
Flupropanate-sodium
Application Date
Application Number
153051
Application Product Name
Flupropanate-sodium
Application details
Product name:
Flupropanate-sodium
Active name:
Flupropanate-sodium
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Flupropanate-sodium for use in agricultural chemical products.
Description of data provided:
Data no
305607
Title
MANUFACTURING PROCESS FOR FLUPROPANATE SODIUM 60% TK
Study date
04/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
305608
Title
Impurity Profile and Assessment Report
Study date
22/04/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
305609
Title
Declaration of composition
Study date
23/04/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
305606
Title
FIVE BATCH ANALYISS OF FLUPROPANATE SODIUM 60% TK
Study date
31/03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
152717
Product/Active constituent Name
Application Product Name
Moxispot for Cats over 4 kg
Application Date
Application Number
152717
Application Product Name
Moxispot for Cats over 4 kg
Application details
Product name:
Moxispot for Cats over 4 kg
Product number:
97307
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 10 g/L moxidectin and 100 g/L imidacloprid, spot-on product for the treatment and control of flea and worm, and the prevention of heartworm in cats over 4kg.
Reference details:
55326 - ADVOCATE SPOT-ON FOR CATS OVER 4KG
Description of data provided:
Data no
303652
Title
GMP CERTIFICATE
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303651
Title
Finished Product specifications
Study date
2024
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
152718
Product/Active constituent Name
Application Product Name
Moxispot for Kittens and Small Cats Up To 4 kg
Application Date
Application Number
152718
Application Product Name
Moxispot for Kittens and Small Cats Up To 4 kg
Application details
Product name:
Moxispot for Kittens and Small Cats Up To 4 kg
Product number:
97308
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 10 g/L moxidectin and 100 g/L imidacloprid spot-on product for the treatment and control of flea and worm, and the prevention of heartworm in kittens, small cats up to 4 kg, and ferrets.
Reference details:
55325 - ADVOCATE SPOT-ON FOR KITTENS AND SMALL CATS UP TO 4KG
Description of data provided:
Data no
303653
Title
Finished Product specifications
Study date
2024
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303654
Title
GMP CERTIFICATE
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
152719
Product/Active constituent Name
Application Product Name
Moxispot for Dogs over 25 kg
Application Date
Application Number
152719
Application Product Name
Moxispot for Dogs over 25 kg
Application details
Product name:
Moxispot for Dogs over 25 kg
Product number:
97309
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 25 g/L moxidectin and 100 g/L imidacloprid spot-on product for the treatment and control of flea and worm, and the prevention of heartworm in dogs over 25kg.
Reference details:
55323 - ADVOCATE SPOT-ON FOR DOGS OVER 25KG
Description of data provided:
Data no
303655
Title
Finished Product specifications
Study date
2024
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303656
Title
GMP certificate
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
152720
Product/Active constituent Name
Application Product Name
Moxispot for Dogs 10-25 kg
Application Date
Application Number
152720
Application Product Name
Moxispot for Dogs 10-25 kg
Application details
Product name:
Moxispot for Dogs 10-25 kg
Product number:
97310
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 25 g/L moxidectin and 100 g/L imidacloprid spot-on product for the treatment and control of flea and worm, and the prevention of heartworm in dogs 10-25 kg.
Reference details:
55322 - ADVOCATE SPOT-ON FOR DOGS 10-25 KG
Description of data provided:
Data no
303658
Title
GMP certificate
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303659
Title
Notes on the Reference Product
Study date
2026
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303657
Title
Finished Product specifications
Study date
2024
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
152721
Product/Active constituent Name
Application Product Name
Moxispot for Dogs 4-10 kg
Application Date
Application Number
152721
Application Product Name
Moxispot for Dogs 4-10 kg
Application details
Product name:
Moxispot for Dogs 4-10 kg
Product number:
97311
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 25 g/L moxidectin and 100 g/L imidacloprid spot-on product for the treatment and control of flea and worm, and the prevention of heartworm in dogs 4-10 kg.
Reference details:
55321 - ADVOCATE SPOT-ON FOR DOGS 4-10 KG
Description of data provided:
Data no
303661
Title
GMP certificate
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303662
Title
Notes on the Reference Product
Study date
2026
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303660
Title
Finished Product specifications
Study date
2024
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
152722
Product/Active constituent Name
Application Product Name
SELASURE FOR PUPPIES AND KITTENS UP TO 2.5 kg
Application Date
Application Number
152722
Application Product Name
SELASURE FOR PUPPIES AND KITTENS UP TO 2.5 kg
Application details
Product name:
SELASURE FOR PUPPIES AND KITTENS UP TO 2.5 kg
Product number:
97312
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 60 g/L selamectin spot-on product for the treatment and control of flea, ear mites, sarcoptic mange, biting lice and hookworm, roundworm, and the prevention of heartworm in puppies and kittens.
Reference details:
50867 - REVOLUTION FOR PUPPIES AND KITTENS
Active constituents:
Active constituent name
95780 - Selamectin
Description of data provided:
Data no
303664
Title
GMP CERTIFICATE
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
303663
Title
Finished Product specifications
Study date
2024
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
152873
Product/Active constituent Name
Application Product Name
NC Isoxaflutole 750 WG Herbicide
Application Date
Application Number
152873
Application Product Name
NC Isoxaflutole 750 WG Herbicide
Application details
Product name:
NC Isoxaflutole 750 WG Herbicide
Applicant Name:
AUSTRALIAN AGVET REGISTRATION SOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 750 g/kg isoxaflutole water dispersible granule for the control and suppression of various broadleaf weeds and grasses in sugarcane and chickpeas
Date
Application Date
Application No
Application Number
152874
Product/Active constituent Name
Application Product Name
NC S-Metolachlor 960 EC Herbicide
Application Date
Application Number
152874
Application Product Name
NC S-Metolachlor 960 EC Herbicide
Application details
Product name:
NC S-Metolachlor 960 EC Herbicide
Applicant Name:
AUSTRALIAN AGVET REGISTRATION SOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 960 g/L S-METOLACHLOR Emulsifiable Concentrate (EC) for the control of certain annual grasses and broadleaf weeds in certain crops
Date
Application Date
Application No
Application Number
153235
Product/Active constituent Name
Application Product Name
EXMITE ORAL SOLUTION FOR CHICKENS
Application Date
Application Number
153235
Application Product Name
EXMITE ORAL SOLUTION FOR CHICKENS
Application details
Product name:
EXMITE ORAL SOLUTION FOR CHICKENS
Product number:
97458
Applicant Name:
ALLVITA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 10 g/L fluralaner oral solution for the treatment and control of poultry red mite (Dermanyssus gallinae) infestation in pullets, breeders and layer hens.
Reference details:
85688 - EXZOLT FLURALANER ORAL SOLUTION FOR CHICKENS
Active constituents:
Active constituent name
95374 - Fluralaner
Description of data provided:
Data no
304943
Title
Finished Product specifications
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Data no
304944
Title
Overseas Site GMP certificate
Study date
2025
Auth party contact address
Level 5, 47 Blazey Street RICHMOND Australia
Date
Application Date
Application No
Application Number
153263
Product/Active constituent Name
Application Product Name
Agro-Essence Diquat 200 SL Herbicide
Application Date
Application Number
153263
Application Product Name
Agro-Essence Diquat 200 SL Herbicide
Application details
Product name:
Agro-Essence Diquat 200 SL Herbicide
Applicant Name:
THEYES MANAGEMENT PTY LTD
Application purpose and description of use:
Registration of a 200 g/L DIQUAT PRESENT AS DIQUAT DIBROMIDE MONOHYDRATE soluble concentrate (SL) for pre-harvest desication and the control of a wide range of broadleaf weeds in certain crops as per Directions For Use. For application through aircraft and ground equipment.
Date
Application Date
Application No
Application Number
151858
Product/Active constituent Name
Application Product Name
HyperT thiamazole
Application Date
Application Number
151858
Application Product Name
HyperT thiamazole
Application details
Product name:
HyperT thiamazole
Product number:
97100
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a 10 mg/mL thiamazole oral solution product for the treatment of hyperthyroidism is cats.
Reference details:
91237 - Thyronorm Oral Solution for Cats
63928 - FELIMAZOLE 5 MG COATED TABLET
93912 - FELIMAZOLE 5 MG/ML ORAL SOLUTION
63928 - FELIMAZOLE 5 MG COATED TABLET
Active constituents:
Active constituent name
97101 - Thiamazole
Description of data provided:
Data no
301205
Title
Certificates of Analysis
Study date
10/2016
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301228
Title
Day 105 Consolidated List of Questions
Study date
05/2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301222
Title
Pharmacology
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301213
Title
Residual Solvents
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301193
Title
Excipient certificates of Analyses
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301242
Title
Certificate of GMP Compliance of a Manufacturer
Study date
05/2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301199
Title
Manufacturer TSE Declaration
Study date
08/2018
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301236
Title
Combined Summary of Product Characteristics
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301185
Title
Quantitative Particulars
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301225
Title
Tolerance in the target animal species
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301216
Title
Pharmacology
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301219
Title
User Safety
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301196
Title
Technical specifications of packaging components
Study date
05/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301239
Title
Scientific Argument for Omission of Health Module
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301220
Title
User Safety Bibliography
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301197
Title
Control of Substances of Biological Origin
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301234
Title
Summary of Product Characteristics
Study date
11/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301240
Title
Scientific Argument to Support Efficacy
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301231
Title
Day 150 consolidated list of Questions.
Study date
12/2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301208
Title
Bioburden Method Validation Report
Study date
11/2018
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301223
Title
Bioequivalence Study Report
Study date
03/2017
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301214
Title
Residual Solvents Declaration
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301194
Title
Control of the Starting Materials Container Closure System
Study date
05/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301217
Title
Toxicology
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301188
Title
Description of the Manufacturing Process
Study date
11/2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301200
Title
Control of Intermediate Substances
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301237
Title
APVMA Application Summary
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301232
Title
Day 190 RMS Assessment of the Day 170 Applicant's Response to the Day 150 Consolidated List of Questions
Study date
01/2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301203
Title
Identification and assay of excipient components
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301226
Title
Publicly Available Assessment Report for a Veterinary Medicinal Product
Study date
26/03/2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301209
Title
PET Method Validation Report
Study date
01/2017
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301215
Title
Precise Identification of the Product and its Active Substances
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301218
Title
Behavioral consequences of Perinatal Hypothyroidism in Postnatal and Adult Rats
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301195
Title
Declarations of Conformance
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301189
Title
Certificate of GMP Compliance of a Manufacturer
Study date
12/10/2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301238
Title
Final PAA Written Assistance - 150522
Study date
23/01/2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301206
Title
Analytical method validation
Study date
09/2016
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301229
Title
Day 120 RMS Assessment of the Applicant's Response to the Day 105 Consolidated List of Questions
Study date
11/2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301183
Title
Qualitative Particulars
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301212
Title
Stability of the Finished Product
Study date
03/2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301235
Title
Labelling and Package Leaflet
Study date
01/2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301186
Title
Development Pharmaceutics
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301192
Title
Control of Excipients
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301230
Title
Day 150 Consolidated list of Questions
Study date
12/2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301184
Title
Usual Terminology
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301201
Title
General Characteristics of the Finished Product
Study date
03/2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301224
Title
Development of Resistance
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301187
Title
Development Technical Reports
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301227
Title
Day 105 Consolidated List of Questions & Applicant responses.
Study date
05/2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301204
Title
Safety Tests
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301241
Title
Executive Summary
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301221
Title
User Risk Assessment References
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301198
Title
TSE/BSE, GMO Declarations
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301233
Title
Day 190 RMS Assessment of the Day 170 Applicant's Response to the Day 150 Consolidated List of Questions
Study date
01/2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Date
Application Date
Application No
Application Number
151859
Product/Active constituent Name
Application Product Name
Thiamazole
Application Date
Application Number
151859
Application Product Name
Thiamazole
Application details
Product name:
Thiamazole
Active name:
Thiamazole
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
301422
Title
Control of Active Substances
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301425
Title
Certificates of Analysis
Study date
2026
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301426
Title
Stability Test on the Active Substance
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301423
Title
Certificate of suitability
Study date
11/2018
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301424
Title
Identification and Assay of the Active Substance
Study date
10/2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
301427
Title
Stability Data
Study date
12/2016
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia