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

150520
Product/Active constituent Name

Application Product Name

IMIDACLOPRID 100 MG/ML + MOXIDECTIN 10 MG/ML SPOT ON SOLUTION FOR CATS

Application details

Product name:

IMIDACLOPRID 100 MG/ML + MOXIDECTIN 10 MG/ML SPOT ON SOLUTION FOR CATS

Product number:

96723

Applicant Name:

ASHISH LIFE SCIENCE PVT. LTD.

Application purpose and description of use:

Registration of a 100 mg/mL imidacloprid, 10 mg/mL moxidectin topical solution for the treatment of fleas, heartworm and worms in cats.

Reference details:

55326 - ADVOCATE SPOT-ON FOR CATS OVER 4KG

Active constituents:

Active constituent name
96724 - Imidacloprid
Active constituent name
96734 - moxidectin

Description of data provided:

Data no
293468
Author
Anon
Title
Certificate-2
Study date
2025
Authorising party
Applicant
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
293467
Author
Anon
Title
Product specifications
Study date
2025
Authorising party
Applicant
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date

Application Date

Application No

Application Number

150737
Product/Active constituent Name

Application Product Name

Esafoxolaner

Application details

Product name:

Esafoxolaner

Active name:

Esafoxolaner

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of esafoxolaner for use in veterinary chemical products to add a new source of active.

Description of data provided:

Data no
294753
Author
Boehringer Ingelheim
Title
Specifications for the Drug Substance - Esatoxolaner
Study date
6 May 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294756
Author
Unknown
Title
Certificate of Analysis Batch 13
Study date
24 May 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294759
Author
Boehringer Ingelheim
Title
Stability Data - Accelerated and Long-Term Stability Studies for the Drug Substance
Study date
07 Jul 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294757
Author
Unknown
Title
Certificate of Analysis Batch 14
Study date
27 May 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294754
Author
Boehringer Ingelheim
Title
Batch Analyses for the Drug Substance
Study date
11 Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294760
Author
Boehringer Ingelheim
Title
Validation of Analytical Procedure for the Drug Substance
Study date
29 February 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294755
Author
Unknown
Title
Certificate of Analysis Batch 12
Study date
21 May 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294752
Author
Eudra
Title
Certifcate of GMP Compliance of a manufacturer
Study date
13/08/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294758
Author
Boehringer Ingelheim
Title
Analytical Procedure for the Drug Substance
Study date
20 Jan 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

150422
Product/Active constituent Name

Application Product Name

David Grays Brodifacoum Wax Block Rat Bait

Application details

Product name:

David Grays Brodifacoum Wax Block Rat Bait

Applicant Name:

DAVID GRAY & CO. PTY LIMITED

Application purpose and description of use:

Registration of a (0.05 g/kg BRODIFACOUM) Bait product for the control of rats and mice, including those resistant to other anticoagulants, in and around industrial, commercial, public services and domestic buildings.
Date

Application Date

Application No

Application Number

150005
Product/Active constituent Name

Application Product Name

CHLORANTRANILIPROLE

Application details

Product name:

CHLORANTRANILIPROLE

Active name:

CHLORANTRANILIPROLE

Applicant Name:

UPL AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of chlorantraniliprole for use in agricultural chemical products.

Description of data provided:

Data no
293021
Author
Desai, H
Title
Validation of analytical method for determination of Chlorantraniliprole and its associated impurities content in Chlorantraniliprole technical grade active ingredient (TGAI)
Study date
February, 2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
293018
Author
Bhujbal, N. & Udawant, D
Title
The manufacturing process of Chlorantraniliprole technical
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
293019
Author
Desai, H
Title
Analysis of five representative production batches of Chlorantraniliprole technical grade active ingredient (TGAI) to determine % Chlorantraniliprole and to quantify its associated impurities
Study date
February, 2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
293022
Author
Pandya, H
Title
QSAR Evaluation on the Toxicity Potential for Chlorantraniliprole and Impurities using DEREK and SARAH Nexus
Study date
June, 2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
293017
Author
Anon.
Title
Part 2: Chemistry & Manufacture dossier
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
293020
Author
Bhujbal, N
Title
Declaration of Composition
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date

Application Date

Application No

Application Number

150391
Product/Active constituent Name

Application Product Name

Thursday Plantation Walkabout Insect Repellent

Application details

Product name:

Thursday Plantation Walkabout Insect Repellent

Product number:

96682

Applicant Name:

HOMART WELLNESS AUST PTY LTD

Application purpose and description of use:

Registration of a (concentration/active) household insecticide product containing Tea Tree Oil (Melaleuca Oil), Lemon scented Tea Tree Oil (Leptospermum Petersonii Leaf Oil) and Citronellal for personal protection against biting insects and flies.

Reference details:

46146 - THURSDAY PLANTATION AUSTRALIA'S ORIGINAL WALKABOUT INSECT REPELLENT

Description of data provided:

Data no
294555
Author
Homart Wellness AUST Pty Ltd
Title
Safety Data Sheet
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294556
Author
Tismor Health & Wellness Pty Ltd
Title
Packaging Work Order
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294553
Author
Tismor Health & Wellness Pty Ltd
Title
Batch 409334 Certificate of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294554
Author
Homart Wellness AUST Pty Ltd
Title
Product Label
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294557
Author
APVMA
Title
Holder Transfer Notice
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Data no
294552
Author
Tismor Health & Wellness Pty Ltd
Title
Finished Product Specification
Study date
2025
Authorising party
Applicant
Auth party contact address
59 Kirby St RYDALMERE Australia
Date

Application Date

Application No

Application Number

150110
Product/Active constituent Name

Application Product Name

AL FAST KNOCKDOWN FLY & MOSQUITO KILLER LOW ALLERGENIC

Application details

Product name:

AL FAST KNOCKDOWN FLY & MOSQUITO KILLER LOW ALLERGENIC

Product number:

96617

Applicant Name:

AARON LABORATORIES PROPRIETARY LIMITED

Application purpose and description of use:

Registration of a 2.41g/kg Bioallethrin Aerosol product to kill flies, mosquitoes, spiders, ants, cockroaches, fleas and silverfish

Reference details:

69855 - MORTEIN FAST KNOCKDOWN FLY & MOSQUITO KILLER LOW ALLERGENIC

Active constituents:

Active constituent name
56859 - BIOALLETHRIN
Active constituent name
56859 - BIOALLETHRIN
Active constituent name
53468 - BIOALLETHRIN
Date

Application Date

Application No

Application Number

150551
Product/Active constituent Name

Application Product Name

MOXIVET CATTLE POUR-ON

Application details

Product name:

MOXIVET CATTLE POUR-ON

Product number:

96743

Applicant Name:

VETPHARM PTY LIMITED

Application purpose and description of use:

Registration of a 5 g/L moxidectin pour-on product for the treatment and control of moxidectin-sensitive internal and external parasites of cattle and for the treatment and control of lungworm and gastrointestinal roundworms of red deer.

Reference details:

45970 - CYDECTIN POUR-ON FOR CATTLE AND RED DEER

Active constituents:

Active constituent name
85141 - MOXIDECTIN

Description of data provided:

Data no
294300
Author
Anon
Title
Product specifications
Study date
2025
Authorising party
Applicant
Auth party contact address
7/20 St Johns Road Gordon Australia
Date

Application Date

Application No

Application Number

150671
Product/Active constituent Name

Application Product Name

Azaperone

Application details

Product name:

Azaperone

Active name:

Azaperone

Applicant Name:

PAH AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of azaperone for use in veterinary chemical products.

Description of data provided:

Data no
294567
Author
Anon
Title
Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Date

Application Date

Application No

Application Number

150440
Product/Active constituent Name

Application Product Name

PORCILIS LAWSONIA IDAL INACTIVATED VACCINE FOR PIGS

Application details

Product name:

PORCILIS LAWSONIA IDAL INACTIVATED VACCINE FOR PIGS

Product number:

91825

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of product registration and label approval to add another pack size 200 doses.

Active constituents:

Active constituent name
91350 - Lawsonia intracellularis strain SPAH-08

Description of data provided:

Data no
293070
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293067
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293073
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293068
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293074
Author
A. Verheul
Title
Additional expert report on quality
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293071
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293072
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293066
Author
MSD Animal Health
Title
Proposal for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293069
Author
MSD Animal Health
Title
Proposed for variation concerning Porcilis Lawsonia ID
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293075
Author
MSD Animal Health
Title
Product characteristic summary
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

150458
Product/Active constituent Name

Application Product Name

VICTRATO Quattro TYMIRIUM technology Seed Treatment

Application details

Product name:

VICTRATO Quattro TYMIRIUM technology Seed Treatment

Product number:

96703

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 133.3 g/L cyclobutrifluram plus 40 g/L difenoconazole plus 10 g/L metalaxyl-M plus 8.33 g/L sedaxane FS product for control or suppression of seedling diseases and suppression of crown rot in barley and wheat.

Reference details:

91436 - VICTRATO TYMIRIUM technology Seed Treatment
64098 - VIBRANCE FUNGICIDE SEED TREATMENT

Active constituents:

Active constituent name
91435 - CYCLOBUTRIFLURAM
Active constituent name
44456 - DIFENOCONAZOLE
Active constituent name
82772 - Difenoconazole
Active constituent name
91191 - Difenoconazole
Active constituent name
65145 - SEDAXANE
Active constituent name
44550 - METALAXYL-M

Description of data provided:

Data no
294684
Author
N B Narayanappa
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - Acute Inhalation Toxicity in Wistar Rats
Study date
18/07/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294701
Author
Thompson, N
Title
Efficacy trial for SYNSTF24
Study date
8 April 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294693
Author
Teese, E
Title
Efficacy trial for SYNSTF24
Study date
18 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294681
Author
K Patterson
Title
Part 3 ??? Toxicology
Study date
September 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294687
Author
B S Yogeesh
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - Acute Skin Irritation/ Corrosion Study In New Zealand White Rabbits Study in Rabbits
Study date
12/06/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294673
Author
Khot, S
Title
A24500A - Chemical Characterization of Batch SGKL0037
Study date
21 November 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294690
Author
K Patterson
Title
Toxicological Database ??? Cyclobutrifluram
Study date
30/09/2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294682
Author
B K K R Reddy
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - Acute Oral Toxicity Study in Wistar Rats
Study date
25/06/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294688
Author
N Nagendrappa
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
Study date
25/06/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294676
Author
Jackson, W
Title
A24500A - Safety Study
Study date
24 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294699
Author
Frost, P.
Title
Efficacy trial for SYNSTF24
Study date
22 February 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294685
Author
B S Yogeesh
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - Acute Eye Irritation/Corrosion Study in New Zealand White Rabbits
Study date
19/06/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294679
Author
Khot, S
Title
A24500A - Validation of Analytical Method ST-82/2
Study date
05 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294696
Author
Ryan, C
Title
Efficacy trial for SYNSTF24
Study date
23 May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294680
Author
K Patterson
Title
Safety Data Sheets Co-formulants A24500A
Study date
01/06/2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294674
Author
Khot, S
Title
A24500A ??? Physical and Technical Properties of Batch SGKL0037
Study date
21 November 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294691
Author
S Roberts
Title
Part 8 ??? Efficacy and Crop Safety
Study date
September 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294697
Author
Smith, E
Title
Efficacy trial for SYNSTF24
Study date
9 May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294683
Author
C G De Andrade
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - Acute Dermal Toxicity Waiver
Study date
26/07/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294677
Author
Khot, S
Title
A24500A - Storage Stability and Shelf Life Statement (2 Weeks 54 ??C and 4 Weeks 54 ??C) in Packaging Made of Fluorinated HDPE according to CIPAC MT 46.4
Study date
01 February 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294694
Author
Barua, R.
Title
Efficacy trial for SYNSTF24
Study date
08 May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294700
Author
Summer, M
Title
Efficacy trial for SYNSTF24
Study date
9 April 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294686
Author
V Paranthaman
Title
Evaluation of Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) for Ocular Hazard Potential using Bovine Corneal Opacity and Permeability Test
Study date
15/02/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294678
Author
Khot, S
Title
Determination of cyclobutrifluram, difenoconazole, metalaxyl-M and sedaxane in A24500A by HPLC
Study date
05 February 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294689
Author
S B M Kumar
Title
Cyclobutrifluram/Difenoconazole/Metalaxyl-M/Sedaxane FS (A24500A) - Local Lymph Node Assay (LLNA) in CBA/Ca Mice
Study date
10/07/2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294695
Author
Landmeter, D
Title
Efficacy trial for SYNSTF24
Study date
30 November 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294675
Author
Khot, S
Title
A24500A ??? Physico-Chemical Characteristics of Batch SGKL0037
Study date
22 November 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294672
Author
K Patterson
Title
Part 2 ??? Chemistry & Manufacture
Study date
June 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294692
Author
Adams, N
Title
Efficacy trial for SYNSTF24
Study date
22 March 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294698
Author
Frost, P
Title
Efficacy trial for SYNSTF24
Study date
22 February 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

150456
Product/Active constituent Name

Application Product Name

Butroxydim

Application details

Product name:

Butroxydim

Active name:

Butroxydim

Applicant Name:

KINGTAI CHEMICALS CO., LIMITED

Application purpose and description of use:

Approval of Butroxydim for use in agricultural chemical products.

Description of data provided:

Data no
294704
Author
Stephen Chen
Title
Five Batch of Butroxydim Technical
Study date
24/09/2025
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
294705
Author
Nicholas Wen
Title
Part 2 - Chemistry
Study date
24/09/2025
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
294702
Author
George Jiang
Title
The Manufacturing Process of Butroxydim
Study date
17/09/2025
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
294703
Author
Nicholas Wen
Title
Declaration of Composition
Study date
17/09/2025
Authorising party
Applicant
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Date

Application Date

Application No

Application Number

150460
Product/Active constituent Name

Application Product Name

FLUAZINAM

Application details

Product name:

FLUAZINAM

Active name:

FLUAZINAM

Applicant Name:

HEXTAR CHEMICALS PTY LTD

Application purpose and description of use:

Approval to register new source of active constituent

Description of data provided:

Data no
294707
Author
Jiangsu Changqing Agrochemical Co., Ltd.
Title
Letter of Authorization for Chemistry and Manufacture Data Submission
Study date
14.07.2025
Authorising party
Jiangsu Changqing Agrochemical Co., Ltd.
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
294713
Author
Cheng Li, Changqing (Hubei) Biotechnology Co., Ltd.
Title
Manufacturing Process of Fluazinam Technical
Study date
23.08.2025
Authorising party
Changqing (Hubei) Biotechnology Co., Ltd.
Auth party contact address
Manufacturer of active constituent
Data no
294710
Author
Ms. Ling Fu, Nutrichem Laboratory Co., Ltd.
Title
NC-2024-129: Preliminary Analysis and Enforcement Analytical Method of Methyl-tert-butyl ether in Fluazinam Technical
Study date
11.06.2025
Authorising party
Jiangsu Changqing Agrochemical Co., Ltd.
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
294708
Author
Ms. Ling Fu, Nutrichem Laboratory Co., Ltd.
Title
NC-2024-120: Preliminary Analysis and Enforcement Analytical Method of Fluazinam Technical
Study date
11.06.2025
Authorising party
Jiangsu Changqing Agrochemical Co., Ltd.
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
294716
Author
Changqing (Hubei) Biotechnology Co., Ltd.
Title
Safety Data Sheet (SDS) Fluazinam Technical
Study date
27.08.2025
Authorising party
Changqing (Hubei) Biotechnology Co., Ltd.
Auth party contact address
Manufacturer of active constituent
Data no
294711
Author
Ms. Jing Zhang, Nutrichem Laboratory Co., Ltd.
Title
NC-2024-121: Chemical and Physical Characterization of Fluazinam Technical: Solubility, Melting Point, Partition Coefficient, and Vapor Pressure
Study date
17.07.2025
Authorising party
Jiangsu Changqing Agrochemical Co., Ltd.
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
294714
Author
Cheng Li, Changqing (Hubei) Biotechnology Co., Ltd.
Title
Declaration of Composition (DoC)
Study date
23.08.2025
Authorising party
Changqing (Hubei) Biotechnology Co., Ltd.
Auth party contact address
Manufacturer of active constituent
Data no
294709
Author
Ms. Ling Fu, Nutrichem Laboratory Co., Ltd.
Title
NC-2024-120: Confidential Attachment
Study date
11.06.2025
Authorising party
Jiangsu Changqing Agrochemical Co., Ltd.
Auth party contact address
Report sponsor and sister company of the manufacturer
Data no
294715
Author
Changqing (Hubei) Biotechnology Co., Ltd.
Title
Analytical Method of Fluazinam Active Ingredient
Study date
23.08.2025
Authorising party
Changqing (Hubei) Biotechnology Co., Ltd.
Auth party contact address
Manufacturer of active constituent
Data no
294706
Author
Hextar Chemicals Pty. Ltd.
Title
Dossier for approval of a new active constituent Fluazinam
Study date
02.09.2025
Authorising party
Applicant
Auth party contact address
15 ORBISON CRT ENDEAVOUR HILLS Australia
Data no
294712
Author
Ms. Jing Zhang, Nutrichem Laboratory Co., Ltd.
Title
NC-2024-124: Chemical and Physical Characterization of Fluazinam Technical: Color, Physical State, Odor, pH, Dissociation Constant, Density, Accelerated Storage Stability, UV-Vis, Hydrolysis, Oxidation/Reduction , Corrosion Characteristics, Volatility, Oxidability, Flammability, Surface Tension and Explodability
Study date
17.07.2025
Authorising party
Jiangsu Changqing Agrochemical Co., Ltd.
Auth party contact address
Report sponsor and sister company of the manufacturer
Date

Application Date

Application No

Application Number

150548
Product/Active constituent Name

Application Product Name

Fostera Gold PCV MH

Application details

Product name:

Fostera Gold PCV MH

Product number:

87927

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to remove non-standard conditions from the initial registration, to update batch release specifications and to add testing site.

Active constituents:

Active constituent name
83556 - Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Active constituent name
87926 - Porcine Circovirus Type 1-Type 2b Chimera Inactivated
Active constituent name
83587 - MYCOPLASMA HYOPNEUMONIAE INACTIVATED

Description of data provided:

Data no
294283
Author
Zoetis
Title
Batch release certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294289
Author
Zoetis
Title
Thiomersal analytical method
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294286
Author
Zoetis
Title
Validation of method for quantification of adjuvant
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294287
Author
Zoetis
Title
Viscosity monograph
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294284
Author
Zoetis
Title
Antigen specification
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294290
Author
Not Identified
Title
GMP certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294285
Author
Zoetis
Title
Quantification of adjuvant
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294282
Author
Zoetis
Title
Batch release specification
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294288
Author
Zoetis
Title
Adjuvant density
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150550
Product/Active constituent Name

Application Product Name

Fostera Gold PCV Metastim

Application details

Product name:

Fostera Gold PCV Metastim

Product number:

88614

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to remove non-standard conditions from the initial registration, to update batch release specifications and to add testing site.

Active constituents:

Active constituent name
83556 - Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Active constituent name
87926 - Porcine Circovirus Type 1-Type 2b Chimera Inactivated

Description of data provided:

Data no
294295
Author
Zoetis
Title
Validation of method of quantification of adjuvant
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294292
Author
Zoetis
Title
Batch release certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294298
Author
Zoetis
Title
Thiomersal analytical method
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294293
Author
Zoetis
Title
Antigen specification
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294299
Author
Not Identified
Title
GMP certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294296
Author
Zoetis
Title
Viscocity monograph
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294291
Author
Zoetis
Title
Batch release specification
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294297
Author
Zoetis
Title
Adjuvant density
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294294
Author
Zoetis
Title
Quantification of adjuvant
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150590
Product/Active constituent Name

Application Product Name

GlanEry 7 in 1 B12 Vaccine for Sheep

Application details

Product name:

GlanEry 7 in 1 B12 Vaccine for Sheep

Product number:

89053

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to add an alternate site for testing.

Active constituents:

Active constituent name
83726 - CLOSTRIDIUM NOVYI TYPE B - TOXOID
Active constituent name
83727 - CLOSTRIDIUM SEPTICUM - TOXOID
Active constituent name
83728 - CLOSTRIDIUM CHAUVOEI - TOXOID
Active constituent name
83730 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
83729 - CLOSTRIDIUM PERFRINGENS TYPE D - TOXOID
Active constituent name
83733 - Corynebacterium pseudotuberculosis (ovis) - toxoid
Active constituent name
84224 - ERYSIPELOTHRIX RHUSIOPATHIAE
Active constituent name
84266 - HYDROXOCOBALAMIN ACETATE
Active constituent name
88084 - Hydroxocobalamin Acetate

Description of data provided:

Data no
294315
Author
not identified
Title
Clostridial potency test RAMTE-1004-02-02_Amend1
Study date
19/08/25
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294318
Author
Zoetis
Title
Challenge Chauvoei
Study date
22 Mar 2018
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294312
Author
Anon
Title
GMP certificate
Study date
21/05/25
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294321
Author
Zoetis
Title
Raw data of guinea pig husbandry
Study date
30/08/2016
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294313
Author
not identified
Title
Comparative testing study4 report
Study date
09/09/25
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294319
Author
Zoetis
Title
Clostridial potency test
Study date
30 May 17
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294316
Author
not identified
Title
Clostridial potency test RAMTE-1004-02-02_Amend2
Study date
19/08/25
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294317
Author
Zoetis Australia Pty Ltd
Title
Regulatory Justification
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294311
Author
EUDRA
Title
GMP certificate
Study date
15/05/23
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294314
Author
not identified
Title
Clostridial potency test RAMTE-1004-02-02
Study date
17/07/25
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294320
Author
Zoetis
Title
Raw data potency testing
Study date
Nov 16, 2016
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

149958
Product/Active constituent Name

Application Product Name

FLUXAPYROXAD

Application details

Product name:

FLUXAPYROXAD

Active name:

FLUXAPYROXAD

Applicant Name:

Rudong Zhongyi Chemical Co. Ltd

Application purpose and description of use:

Approval of Fluxapyproxad active constituent for use in agricultural chemical products.

Description of data provided:

Data no
292861
Author
Zhang Jin
Title
MANUFACTURING PROCESS AND FORMATION OF IMPURITIES OF FLUXAPYROXAD TECHNICAL
Study date
25 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Data no
292862
Author
Zhang Jin
Title
Declartion of composition
Study date
27 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Data no
292863
Author
Zhang Jin
Title
SPECIFICATION OF FLUXAPYROXAD TECHNICAL
Study date
27 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Data no
292860
Author
Nat??lia Tagliacozzi Galv??o
Title
Qualitative and Quantitative Profile of Fluxapyroxad (Five Batch Analysis)
Study date
26 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Date

Application Date

Application No

Application Number

149969
Product/Active constituent Name

Application Product Name

Boscalid

Application details

Product name:

Boscalid

Active name:

Boscalid

Applicant Name:

Rudong Zhongyi Chemical Co. Ltd

Application purpose and description of use:

Approval of Boscalid active constituent for use in agricultural chemical products.

Description of data provided:

Data no
292918
Author
Zhan Jin
Title
MANUFACTURING PROCESS AND FORMATION OF IMPURITIES OF BOSCALID TECHNICAL
Study date
12 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Data no
292919
Author
Zhan Jin
Title
Declaration of Composition of Boscalid
Study date
12 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Data no
292917
Author
Natalia Tagliacozzi Galvao
Title
Qualitative and Quantitative Profile of Boscalid (Five Batch Analysis)
Study date
11 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Data no
292920
Author
Zhang Jin
Title
SPECIFICATION OF BOSCALID TECHNICAL
Study date
12 Aug 2025
Authorising party
Applicant
Auth party contact address
The Second Haibin Road Coastal Economic Development Zone Rudong China
Date

Application Date

Application No

Application Number

150374
Product/Active constituent Name

Application Product Name

NITROMEC INJECTION ENDECTOCIDE AND FLUKICIDE FOR CATTLE

Application details

Product name:

NITROMEC INJECTION ENDECTOCIDE AND FLUKICIDE FOR CATTLE

Product number:

59844

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Variation of product label approval to amend label details.

Active constituents:

Active constituent name
83039 - NITROXYNIL
Active constituent name
82991 - Clorsulon
Active constituent name
52892 - IVERMECTIN
Active constituent name
84516 - IVERMECTIN

Description of data provided:

Data no
292397
Author
APVMA
Title
Residues Evaluation Report
Study date
10 July 2006
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
292398
Author
APVMA
Title
Residues Evaluation Report
Study date
16 July 2008
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
292395
Author
Virbac
Title
Cover Letter
Study date
18 August 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
292396
Author
Virbac
Title
Part 5A and 5B Residues
Study date
August 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
292399
Author
Virbac
Title
Application for a technical label change
Study date
May 2017
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

150375
Product/Active constituent Name

Application Product Name

NITROFLUKE INJECTION FLUKICIDE FOR CATTLE

Application details

Product name:

NITROFLUKE INJECTION FLUKICIDE FOR CATTLE

Product number:

70184

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Variation of product label to amend label details.

Active constituents:

Active constituent name
83039 - NITROXYNIL
Active constituent name
82991 - Clorsulon

Description of data provided:

Data no
293064
Author
APVMA
Title
Residues Evaluation Report
Study date
16 July 2008
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
293061
Author
Virbac
Title
Cover Letter
Study date
18 August 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
293062
Author
Virbac
Title
Part 5A and 5B Residues
Study date
August 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
293065
Author
Virbac
Title
Application for a technical label change
Study date
May 2017
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
293063
Author
APVMA
Title
Residues Evaluation Report
Study date
10 July 2006
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

150414
Product/Active constituent Name

Application Product Name

ASTRO 120 ME GROWTH REGULATOR

Application details

Product name:

ASTRO 120 ME GROWTH REGULATOR

Product number:

64368

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

To add label claims to label/registration.

Reference details:

64368 - ASTRO 120 ME GROWTH
64368 - ASTRO 120 ME GROWTH REGULATOR
64368 - TRINEX 120 ME GROWTH REGULATOR
83378 - QUALI-PRO Marvel Ultra Plant Growth Regulator
94862 - Primo HG Turf Growth Regulator

Active constituents:

Active constituent name
64034 - TRINEXAPAC-ETHYL

Description of data provided:

Data no
294575
Author
APVMA
Title
re Human Health Risk Assessment for application 64368_137390
Study date
15 September 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
294578
Author
W Braybon
Title
Astro120 ME Growth Regulator - Executive Summary
Study date
30 September 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
294573
Author
APVMA
Title
64368_114803-Astro 120 ME Growth-regulator - HHRA FTR Applicant copy
Study date
17 January 2019
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
294576
Author
ECHA
Title
ECHA Registration dossier
Study date
May 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
294577
Author
W Braybon
Title
Astro 120 ME Growth Regulator - Part 3 Work Health & Safety Summary
Study date
30 September 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
294574
Author
APVMA
Title
Astro 120 ME - 64368_137390 - Regulation 70B(3) - Notice of Recat'n
Study date
20 February 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia