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

150765
Product/Active constituent Name

Application Product Name

Fluxapyroxad

Application details

Product name:

Fluxapyroxad

Active name:

Fluxapyroxad

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Approval of Fluxapyroxad for use in agricultural chemical products.

Description of data provided:

Data no
296311
Author
Anon
Title
Fluxapyroxad Executive Summary 1125
Study date
November 2025
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296312
Author
Yu Bo
Title
Fluxapyroxad Technical Synthesis Process-0822v1
Study date
August 2025
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296313
Author
Yu Bo
Title
DECLARATION OF COMPOSITION
Study date
September 2025
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296314
Author
Jana Skopec
Title
Determination of Active Content and Impurity Profile of Fluxapyroxad Technical
Study date
October 2024
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296315
Author
Anon
Title
Fluxapyroxad - Part 2-Chemistry 1125
Study date
November 2025
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
309705
Author
Yo Bo
Title
Fluxapyroxad?Technical?Synthesis?Process-0822 v1-1
Study date
10-08-2026
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
309706
Author
Yu Bo
Title
DoC?_Fluxapyroxad?v1-1
Study date
05-08-2026
Authorising party
Applicant
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Date

Application Date

Application No

Application Number

150726
Product/Active constituent Name

Application Product Name

Chlorantraniliprole

Application details

Product name:

Chlorantraniliprole

Active name:

Chlorantraniliprole

Applicant Name:

JIANGSU YANGNONG CHEMICAL CO. LTD

Application purpose and description of use:

Approval of Chlorantraniliprole for use in agricultural chemical products.
Date

Application Date

Application No

Application Number

150724
Product/Active constituent Name

Application Product Name

PYROXASULFONE

Application details

Product name:

PYROXASULFONE

Active name:

PYROXASULFONE

Applicant Name:

JIANGSU YANGNONG CHEMICAL CO. LTD

Application purpose and description of use:

Approval of Pyroxasulfone for use in agricultural chemical products.

Description of data provided:

Data no
296161
Author
Y Zhou
Title
Validation of analytical methodology for the assay of active ingredient and impurities and subsequent five batches qualitative and quantitative analysis of Pyroxasulfone TC
Study date
July 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296164
Author
L Qian
Title
Statement of 5 Batch Size and typical batch size of Pyroxasulfone Technical
Study date
October 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296165
Author
L Qian
Title
Percent composition of Pyroxasulfone TC
Study date
September 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296162
Author
L Qian
Title
PRODUCTION CHEMISTRY OF PYROXASULFONE TECHNICAL
Study date
October 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296163
Author
L Qian
Title
Packing Specification of Pyroxasulfone
Study date
October 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Date

Application Date

Application No

Application Number

150725
Product/Active constituent Name

Application Product Name

Indaziflam

Application details

Product name:

Indaziflam

Active name:

Indaziflam

Applicant Name:

JIANGSU YANGNONG CHEMICAL CO. LTD

Application purpose and description of use:

Approval of Indaziflam for use in agricultural chemical products.

Description of data provided:

Data no
307803
Author
Xiao Yang
Title
Percent composition of Indaziflam TC
Study date
July 2026
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296167
Author
Y Zhou
Title
Validation of analytical methodology forthe assay of active ingredient and impurities and subsequent five batches qualitative and quantitative analysis of Indaziflam TC
Study date
June 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296170
Author
X Yang
Title
Analytical Method of Indaziflam TC
Study date
October 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
307801
Author
Xiao Yang
Title
Amendment of Production Chemistry of Indaiflam Technical
Study date
July 2026
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296171
Author
X Yang
Title
Percent composition of Indaziflam TC
Study date
September 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
307804
Author
L Xia
Title
RESPONSE: Indaziflam (96802/150725)
Study date
July 2026
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296168
Author
X Yang
Title
Packing Specification of Indaziflam
Study date
October 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296169
Author
X Yang
Title
Statement of 5 Batch Size and typical batch size of Indaziflam Technical
Study date
October 2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
307802
Author
Anon
Title
Amended 5 batch analysis for Indaziflam (96802/150725)
Study date
July 2026
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Data no
296166
Author
X Yang
Title
PRODUCTION CHEMISTRY OF INDAZIFLAM TECHNICAL
Study date
2025
Authorising party
Applicant
Auth party contact address
39 WENFENG RD YANGZHOU China
Date

Application Date

Application No

Application Number

150113
Product/Active constituent Name

Application Product Name

CLOQUINTOCET-MEXYL

Application details

Product name:

CLOQUINTOCET-MEXYL

Active name:

CLOQUINTOCET-MEXYL

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Approval of cloquintocet-mexyl for use in agricultural chemical products.
Date

Application Date

Application No

Application Number

150687
Product/Active constituent Name

Application Product Name

Nufarm TERRAIN FLOW Herbicide

Application details

Product name:

Nufarm TERRAIN FLOW Herbicide

Product number:

92965

Applicant Name:

SUMITOMO CHEMICAL AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Variation of the label approval to extend the use to include Cotton lay-by and Tea Tree.

Reference details:

92955 - VALOR EZE 480 SC HERBICIDE

Active constituents:

Active constituent name
54434 - FLUMIOXAZIN
Date

Application Date

Application No

Application Number

150826
Product/Active constituent Name

Application Product Name

Pradofloxacin

Application details

Product name:

Pradofloxacin

Active name:

Pradofloxacin

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Approval of a new manufacturing source for an existing API.

Description of data provided:

Data no
295604
Author
Elanco
Title
Apx 2.0 - Specification
Study date
13/10/2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
295605
Author
Anon
Title
Apx 2.1 - Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

150498
Product/Active constituent Name

Application Product Name

FORPINE HERBICIDE

Application details

Product name:

FORPINE HERBICIDE

Product number:

96719

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Registration of a 800g/kg bromacil WG product for the uses as described on the label..

Reference details:

62760 - URAGAN WG HERBICIDE

Active constituents:

Active constituent name
69696 - BROMACIL

Description of data provided:

Data no
295441
Author
Shandong Rainbow International Co., Ltd
Title
Authorised Agent Letter
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295442
Author
Anon
Title
Covering Letter/Executive Summary
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295443
Author
Anon
Title
Part 2 - Chemistry and Manufacture Volume 1
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295444
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms - Part 1
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295445
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms - Part 2
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295446
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms - Part 3
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295447
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms - Part 4
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295448
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Accelerated Storage Stability Study on Bromacil 80% WG HDPE
Study date
January, 2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295449
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Accelerated Storage Stability Study on Bromacil 80% WG LDPE
Study date
January, 2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295450
Author
Anon
Title
Part 8 - Efficacy and Crop Safety - Volume 1
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295451
Author
A. Ford
Title
To prove that weed control provided by Forpine 800WG herbicide is equivalent to Uragan 800WG, Buckley, Victoria
Study date
June, 2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295452
Author
TrialCo Pty Ltd
Title
Rainbow Bromacil 800WG Fallow Trial ??? Replicated, Katanning WA
Study date
December, 2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
312996
Author
M Shaw
Title
Response to Section 159(1)(a) - Notice of requirement of information, report or sample
Study date
Oct 2026
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date

Application Date

Application No

Application Number

150560
Product/Active constituent Name

Application Product Name

Conquest KnockOUT Extreme Herbicide

Application details

Product name:

Conquest KnockOUT Extreme Herbicide

Product number:

85582

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Modify the direction for use for in the current Conquest Knockout Extreme Herbicide label

Reference details:

63268 - ROUNDUP READY HERBICIDE WITH PLANTSHIELD
63268 - ROUNDUP READY HERBICIDE WITH PLANTSHIELD BY MONSANTO

Active constituents:

Active constituent name
64305 - GLYPHOSATE

Description of data provided:

Data no
295611
Author
anon
Title
1KOE - Application Overview
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295612
Author
anon
Title
2KOE - Part 8 - Efficacy and Crop safety of Knockout Extreme
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295613
Author
anon
Title
3KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
May 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295614
Author
anon
Title
4KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295615
Author
anon
Title
5KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
May 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295616
Author
anon
Title
6KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
May 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295617
Author
anon
Title
7KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
May 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295618
Author
anon
Title
8KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295619
Author
anon
Title
9KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295620
Author
anon
Title
10KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295621
Author
anon
Title
11KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295622
Author
anon
Title
12KOE - Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295623
Author
anon
Title
13KOE - EUR3004 Crop Safety and Efficacy Knockout Extreme Herbicide
Study date
April 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295624
Author
anon
Title
14KOE - 23-CON-011_SR_01 Knockout Extreme Residues
Study date
May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295625
Author
anon
Title
15KOE - 23-CON-012_SR_01 Knockout Extreme Residues
Study date
December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
295626
Author
anon
Title
16KOE - Part 5 Residues
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

150563
Product/Active constituent Name

Application Product Name

CEREPIN 100EC SELECTIVE HERBICIDE

Application details

Product name:

CEREPIN 100EC SELECTIVE HERBICIDE

Product number:

89096

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Variation of product registration and label approval to include a new formulation for Cerepin 100EC Selective Herbicide.

Active constituents:

Active constituent name
88344 - Pinoxaden
Active constituent name
61461 - CLOQUINTOCET-MEXYL

Description of data provided:

Data no
295579
Author
Anon
Title
Covering Letter
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295580
Author
Shandong Rainbow International Co., Ltd
Title
Appointment of Authorised Agent Letter
Study date
September,2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295581
Author
Shandong Rainbow International Co., Ltd
Title
Part 2- Chemistry and Manufacturing
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295582
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Accelerated Storage Stability Study on Pinoxaden 100g/L + Cloquintocet-mexyl 25g/L
Study date
June, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295583
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms of Accuracy and Precision
Study date
June, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295584
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms of Content
Study date
June, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295585
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromatograms of Linearity
Study date
June, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295586
Author
Shandong Weifang Rainbow Chemical Co., Ltd
Title
Chromograms of Solvent Blant
Study date
June, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295587
Author
Anon
Title
Part 8 - Efficacy and Crop Safety
Study date
September, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295588
Author
A. Somervaille
Title
Pinoxaden Herbicide Registration in Cereals Report of trial conducted near Jandowae, Qld Trial No: AU435WHEATNth
Study date
August, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295589
Author
A. Somervaille
Title
Pinoxaden Herbicide Registration in Cereals Report of trial conducted near Macalister, Qld Trial No: AU435WHEATNth_2
Study date
August, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
295590
Author
A Forbes and J Forbes
Title
Determine bioequivalence of Rainbow Pinoxaden with Axial 100 EC when applied to annual ryegrass in wheat
Study date
July, 2025
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date

Application Date

Application No

Application Number

150678
Product/Active constituent Name

Application Product Name

Flamobex SPT-3 RTU H3 Timber Treatment

Application details

Product name:

Flamobex SPT-3 RTU H3 Timber Treatment

Product number:

96789

Applicant Name:

STALWART PROTECTIVE TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a 4.5 g/L propiconazole, 4.5 g/L tebuconazole and 3.2 g/L permethrin ready-to-use timber treatment product for the protection of softwood timber to be used for Hazard Level H3 (outside and above ground) situations against timber insects, such as borers and termites and fungal decay.

Reference details:

69272 - PROTIM OPTIMUM RTU (P) LOSP TIMBER PRESERVATIVE
69683 - TIMBERTREAT A AZOLE INSECTICIDE/FUNGICIDE WOOD PRESERVATIVE
64899 - VACSOL AZURE C CLEAR RTU WOOD PRESERVATIVE
62954 - VACSOL AZURE GREEN READY TO USE TIMBER PRESERVATIVE
56786 - VACSOL AZURE CLEAR READY TO USE TIMBER PRESERVATIVE
64897 - VACSOL AZURE C GREEN RTU WOOD PRESERVATIVE
62542 - PROTIM OPTIMUM GOLD RTU (P) LOSP TIMBER PRESERVATIVE
58293 - PROTIM OPTIMUM RTU (HI-FLASH) LOSP TIMBER PRESERVATIVE

Active constituents:

Active constituent name
55229 - PROPICONAZOLE
Active constituent name
69316 - PROPICONAZOLE
Active constituent name
59523 - PROPICONAZOLE
Active constituent name
53896 - TEBUCONAZOLE
Active constituent name
44423 - PERMETHRIN

Description of data provided:

Data no
295737
Author
APVMA
Title
Pre-Application Assistance Flamobex SPT-3 RTU H3 Timber Treatment
Study date
15/02/2024
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295738
Author
Applicant
Title
Summary Chemistry & Manufacture Flamobex
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295739
Author
Applicant
Title
Confidential Data and Information
Study date
Sep 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295740
Author
Anon
Title
Real Time (6 wks, 20??C) Stability Testing Report ??? Flamobex Timber Treatment
Study date
Aug 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295741
Author
ACS Laboratories
Title
Method Validation Results
Study date
Jun 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295742
Author
ACS Laboratories
Title
Method Validation for determination of tebuconazole, propiconazole, permethrin
Study date
Jul 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295743
Author
Applicant
Title
Summary Health Flamobex
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295744
Author
Applicant
Title
Summary Efficacy Flamobex
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295745
Author
Kleinschmidt S.
Title
Field study to determine efficacy of Flamobex SPT-3 RTU H3 Timber Treatment to prevent Subterranean termite damage.
Study date
Mar 2025
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
295746
Author
Australasian Wood Preservation Committee
Title
Protocols for ssessment of wood preservatives.
Study date
Sep 2015
Authorising party
Public
Auth party contact address
-
Data no
311232
Author
Applicant
Title
Flamobex Leaching Argument
Study date
Sep 2026
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Data no
311233
Author
Kukowski K et al
Title
The Extent of Tebuconazole Leaching from Unpainted and Painted Softwood.
Study date
Mar 2018
Authorising party
Public
Auth party contact address
-
Data no
311234
Author
Forest and Wood Products Australia
Title
Finishing Timber Externally
Study date
Sep 2015
Authorising party
Public
Auth party contact address
-
Data no
311235
Author
Humphrey et al.
Title
A Wood Preservative Formulation
Study date
Nov 2017
Authorising party
Public
Auth party contact address
-
Data no
311236
Author
Schoknecht U. et al.
Title
Suitability of analytical methods to determine tebuconazole, propiconazole and permethrin in aged wood samples.
Study date
Jan 2020
Authorising party
Public
Auth party contact address
-
Data no
311237
Author
Vorel V.
Title
Summary of the stability and solubility of the active substrates in the product Flammobex.
Study date
Aug 2026
Authorising party
Applicant
Auth party contact address
13 - 15 Park Ave Coffs Harbour Australia
Date

Application Date

Application No

Application Number

148901
Product/Active constituent Name

Application Product Name

Cloxacillin Benzathine

Application details

Product name:

Cloxacillin Benzathine

Active name:

Cloxacillin Benzathine

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

New source of pharmacopoeia active constituent

Description of data provided:

Data no
307499
Author
Abbey animal health Pty Ltd
Title
Response to S159 notice MAR26
Study date
MAR 2026
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
295815
Author
Abbey Laboratories Pty Ltd
Title
Active COA
Study date
June 2025
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
307500
Author
Abbey Laboratories Pty Ltd
Title
Active Coa
Study date
Mar 26
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
295816
Author
Abbey Laboratories Pty Ltd
Title
Active details
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

150478
Product/Active constituent Name

Application Product Name

CropSure Fluroxypyr 400 Herbicide

Application details

Product name:

CropSure Fluroxypyr 400 Herbicide

Product number:

92589

Applicant Name:

CROPSURE PTY LTD

Application purpose and description of use:

Addition of formulation and active and manufacturing sites

Reference details:

86354 - Spalding Fluroxypyr 400 Herbicide

Active constituents:

Active constituent name
59089 - FLUROXYPYR-MEPTYL
Date

Application Date

Application No

Application Number

149886
Product/Active constituent Name

Application Product Name

CEFOVECIN SODIUM MICRONISED

Application details

Product name:

CEFOVECIN SODIUM MICRONISED

Active name:

CEFOVECIN SODIUM MICRONISED

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

New source of active constituent
Date

Application Date

Application No

Application Number

150411
Product/Active constituent Name

Application Product Name

Avilive Fluroxpyr 400EC Herbicide

Application details

Product name:

Avilive Fluroxpyr 400EC Herbicide

Product number:

96686

Applicant Name:

Zhejiang Avilive Chemical Imp. & Exp. Co., Ltd.

Application purpose and description of use:

Registration of a 400 g/l emulsifiable concentrate present as the FLUROXYPYR AS THE METHYL HEPTYL ESTER product for the Control of a Wide Range of Broadleaf Weeds in Fallow, Lucerne, Maize, Millets, Pastures, Sorghum, Sugar Cane, Sweet Corn, Winter Cereals. Also for the Control of Woody Weeds in Agricultural Non-Crop Areas, Commercial and Industrial Areas, Pastures and Rights-of-Way as Specified in the Directions for Use .

Reference details:

83865 - EUREKA! Fluroxypyr 400 Herbicide
89664 - Farmalinx Swysh 400 EC Herbicide

Active constituents:

Active constituent name
94847 - Fluroxypyr meptyl
Active constituent name
59455 - FLUROXYPYR-MEPTYL
Date

Application Date

Application No

Application Number

149885
Product/Active constituent Name

Application Product Name

Convenia RTU for Dogs

Application details

Product name:

Convenia RTU for Dogs

Product number:

96566

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 160 mg/mL cefovecin Ready-to-Use Injectable suspension for dogs.

Active constituents:

Active constituent name
96567 - CEFOVECIN SODIUM MICRONISED

Description of data provided:

Data no
291200
Author
Zoetis Australia Pty Ltd
Title
Part 1 Overview
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291201
Author
Not Identified
Title
GMP certificate
Study date
July 30, 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291202
Author
Not Identified
Title
Audit Report
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291203
Author
Not Identified
Title
Summary
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291204
Author
Zoetis Australia Pty Ltd
Title
Part 2 Summary
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291205
Author
Not Identified
Title
Chemistry Manufacturing and Control Initial Technical Section
Study date
March 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291206
Author
Zoetis Australia Pty Ltd
Title
Part 8 Summary
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291207
Author
Not Identified
Title
Effectiveness Technical Section
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291208
Author
Not Identified
Title
Target Animal Safety Technical Section
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291209
Author
Ann E. Fielder
Title
Method validation
Study date
21 July 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291210
Author
Ann E. Fielder
Title
Method validation amendment
Study date
21 July 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291211
Author
Natalie Bissland
Title
Partial Method Validation
Study date
12 Nov 2015
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291212
Author
Derek Conti
Title
Bioequivalence study
Study date
11 Oct 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291213
Author
Zoetis
Title
Safety study
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291214
Author
Zoetis
Title
Convenia Safety and Efficacy Review
Study date
11 Oct 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291215
Author
Zoetis
Title
Periodic Safety Update Report
Study date
21 February 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291216
Author
Zoetis Australia Pty Ltd
Title
Part 10 Justification
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291217
Author
Rynhoud et al.
Title
Epidemiology of methicillin resistant Staphylococcus species carriage in companion animals in the Greater Brisbane Area, Australia
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
291218
Author
Davies & Davies
Title
Origins and Evolution of Antibiotic Resistance
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
291219
Author
Saputra et al.
Title
Antimicrobial resistance in coagulase-positive staphylococciisolated from companion animals in Australia: A one yearstudy
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
291220
Author
Loeffler et al.
Title
Antimicrobial use guidelines for canine pyoderma by the International Society for Companion Animal Infectious Diseases (ISCAID)
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
291221
Author
Not Identified
Title
Human User Safety Assessment
Study date
November 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
313006
Author
Zoetis Australia Pty Ltd
Title
s159 response letter
Study date
28/09/2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
313007
Author
Zoetis Inc
Title
3.2.P.3.3. Description of Manufacturing Process and Process Controls
Study date
Sep 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
313008
Author
Zoetis Inc
Title
Residual Solvents
Study date
February 21, 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
313009
Author
Zoetis Inc
Title
CHEMISTRY MANUFACTURING and CONTROL

RESPONSE TO QUESTIONS
Study date
September 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
313010
Author
Zoetis Inc
Title
Regulatory Method of Manufacturing Finished Product
Study date
Sep 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

151021
Product/Active constituent Name

Application Product Name

OXY300 LA Oxytetracycline 300 mg/mL Injection

Application details

Product name:

OXY300 LA Oxytetracycline 300 mg/mL Injection

Applicant Name:

PAH AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 300 mg/mL oxytetracycline (as the dihydrate) injectable product for use as a broad-spectrum antibiotic in cattle, sheep and pigs.
Date

Application Date

Application No

Application Number

150600
Product/Active constituent Name

Application Product Name

Beransa 30 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 30 mg Solution for Injection for Dogs

Product number:

89695

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of the conditions of product registration by extending the shelf life; and variation of conditions of label approval by extending the shelf life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
310860
Author
Zoetis Inc
Title
Determination of Purity of Canine anti NGF by NR-CGE
Study date
18 Jul 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310863
Author
Zoetis Inc
Title
Pharmacopeial test for Endotoxins
Study date
04 Aug 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294326
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294327
Author
Anne Dewilde
Title
Stability Report
Study date
10 Apr 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310866
Author
Zoetis Australia Pty Ltd
Title
s159 response letter
Study date
07 Aug 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310864
Author
Zoetis Inc
Title
Quantification by reverse phase high performance liquid chromatography (RP-HPLC)
Study date
19 Mar 2020
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310861
Author
Zoetis Inc
Title
Determination of specific activity and Quantification of Canine anti NGF
Study date
12 Aug 2021
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310867
Author
Zoetis Inc
Title
Certificate of analysis
Study date
30 July 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310862
Author
Zoetis Inc
Title
Determination of protein content
Study date
20 Apr 2020
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310868
Author
Zoetis Inc
Title
Protein Content by Absorbance - Method Equivalence
Study date
10 Apr 2020
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310859
Author
Zoetis Australia Pty Ltd
Title
s159 response letter
Study date
13 May 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
310865
Author
Zoetis Inc
Title
European Pharmacopoeia Test Methods for Appearance
Study date
10 May 2021
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150649
Product/Active constituent Name

Application Product Name

Beransa 15 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 15 mg Solution for Injection for Dogs

Product number:

89656

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of the conditions of product registration by extending the shelf life; and variation of conditions of label approval by extending the shelf life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
294438
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294439
Author
Anne Dewilde
Title
Stability report
Study date
10 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150650
Product/Active constituent Name

Application Product Name

Beransa 20 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 20 mg Solution for Injection for Dogs

Product number:

89655

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of the conditions of product registration by extending the shelf life; and variation of conditions of label approval by extending the shelf life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
294538
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294539
Author
Anne Dewilde
Title
Stability Report
Study date
10 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia