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

148260
Product/Active constituent Name

Application Product Name

Atlas Kill & Protect Fast Knockdown Multi Insect Spray

Application details

Product name:

Atlas Kill & Protect Fast Knockdown Multi Insect Spray

Product number:

96127

Applicant Name:

PASCOE'S PTY LTD

Application purpose and description of use:

Registration of a 1.0g/kg ESBIOTHRIN 0.3g/kg PERMETHRIN 0.2 g/kg IMIPROTHRIN aerosol product to kill in 1 spray flies, mosquitoes, spiders, ants, cockroaches, fleas, silverfish, moths and wasps Kills in a single spray Kills flying and crawling insects fast

Reference details:

86269 - Atlas Kill & Protect Fast Knockdown Flying Insect Spray
69354 - MORTEIN FAST KNOCKDOWN MULTI INSECT KILLER

Active constituents:

Active constituent name
83451 - IMIPROTHRIN MANUFACTURING CONCENTRATE
Active constituent name
86121 - Esbiothrin
Active constituent name
47665 - PERMETHRIN
Active constituent name
55112 - PERMETHRIN
Active constituent name
55465 - PERMETHRIN
Active constituent name
61830 - PERMETHRIN
Active constituent name
62417 - PERMETHRIN
Active constituent name
63776 - PERMETHRIN

Description of data provided:

Data no
286179
Author
GF Smart
Title
Executive summary: Item 10 application to register Atlas Kill & Protect Fast Knockdown Multi Insect Spray
Study date
April 2025
Authorising party
Applicant
Auth party contact address
40-46 Fairfield St Fairfield Australia
Date

Application Date

Application No

Application Number

148329
Product/Active constituent Name

Application Product Name

FRONTLINE PLUS (FIPRONIL PLUS (S)-METHOPRENE) FOR DOGS

Application details

Product name:

FRONTLINE PLUS (FIPRONIL PLUS (S)-METHOPRENE) FOR DOGS

Product number:

54523

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of product registration to vary the registered particulars of the product.

Active constituents:

Active constituent name
55179 - (S)-METHOPRENE
Active constituent name
49120 - FIPRONIL MANUFACTURING CONCENTRATE
Active constituent name
83657 - FIPRONIL

Description of data provided:

Data no
285718
Author
Boehringer Ingelheim
Title
Batch Analyses for the Drug Product vq00016470
Study date
8 Feb 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285713
Author
Boehringer Ingelheim Animal Health
Title
Part 2 Chemistry and Manufacture
Study date
1 May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285714
Author
Boehringer Ingelheim Animal Health
Title
Appendix 1
Study date
1 May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285717
Author
Boehringer Ingelheim
Title
Specifications for the Drug Product vq00016469
Study date
31 Jan 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285723
Author
Boehringer Ingelheim Animal Health
Title
Justification of Change vr0028571
Study date
23 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285724
Author
Boehringer Ingelheim Animal Health
Title
Justification of Change vr00208749
Study date
23 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285715
Author
Boehringer Ingelheim Animal Health
Title
Stability Data vq00014957
Study date
26 Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285716
Author
Boehringer Ingelheim Animal Health
Title
Stability Summary and Conclusions vq00015829
Study date
12 Oct 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285719
Author
Boehringer Ingelheim Animal Health
Title
Stability Data vq00016794
Study date
26 Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285720
Author
Boehringer Ingelheim
Title
Stability Data vq00017421
Study date
23 Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285721
Author
Boehringer Ingelheim Animal Health
Title
Stability Data vq00017856
Study date
11 Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285722
Author
Boehringer Ingelheim Animal Health
Title
Stability Summary and Conclusions vq00017859
Study date
10 Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285712
Author
Boehringer Ingelheim Animal Health
Title
Executive Summary
Study date
1 May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

148327
Product/Active constituent Name

Application Product Name

Wagg & Purr Broad-Spectrum Allwormer Tablets for Large Dogs

Application details

Product name:

Wagg & Purr Broad-Spectrum Allwormer Tablets for Large Dogs

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of a 1084mg/Tb oxantel embonate, 286mg/tb Pyrantel embonate, 100mg/tb Praziquantel oral tablet product for the treatment of Roundworm, Hookworm, Whipworm, Tapeworm, plus Hydatid Tapeworm.
Date

Application Date

Application No

Application Number

148432
Product/Active constituent Name

Application Product Name

Quicksilver Herbicide

Application details

Product name:

Quicksilver Herbicide

Product number:

96172

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

Registration of a 240 g/L carfentrazone-ethyl emulsifiable concentrate (EC) product for the Control of Moss in Turf.

Reference details:

63103 - SILVERADO HERBICIDE

Active constituents:

Active constituent name
92581 - Carfentrazone-ethyl

Description of data provided:

Data no
286506
Author
Anon
Title
Carfentrazone-ethyl - CoA
Study date
10 February 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286507
Author
APVMA
Title
Notice of Approval of an Active Constituent
Study date
22 may 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286504
Author
A Yarnton
Title
Method Validation for the determination of carfentrazone-ethyl in Formulation C
Study date
6 August 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286503
Author
Turf Culture P/L
Title
The development of a carfentrazone-ethyl 240 EC
Study date
May 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286508
Author
Various
Title
Quicksilver - Excipient - SDSs
Study date
2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286505
Author
A Yarnton
Title
Testing Stability Report - Carfentrazone-ethyl EC (Formulation C)
Study date
6 August 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286509
Author
Turf Culture P/L
Title
To evaluate 3 products for the control of moss in Bent grass (Agrostis stolonifera) Turf.
Study date
12 November 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286510
Author
Turf Culture P/L
Title
To evaluate 3 products for the control of moss in Bent grass (Agrostis stolonifera) Turf.
Study date
12 March 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286511
Author
Turf Culture P/L
Title
To evaluate 3 products for the control of moss in Bentgrass (Agrostis stolonifera) Turf.
Study date
16 December 2007
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286512
Author
Turf Culture Pty Ltd
Title
Evaluation of the Phytotoxic Potential of TC-009, TC-010, TC-011 and Coliseum on several warm and cool season turfgrass varieties.
Study date
16 March 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286513
Author
Turf Culture Pty Ltd
Title
Evaluation of TC-009, TC-011 and TC-012 for the control of Moss in Bentgrass (Agrostis stolonifera) Turf
Study date
12 November 2011
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286519
Author
Zane Raudenbush , Steven J. Keeley , Cole Thompson and Mithila Jugulam4
Title
Dose responses of silvery-thread moss (Bryum argenteum) to carfentrazone-ethyl
Study date
8 June 2021
Authorising party
Public
Auth party contact address
-
Data no
286520
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
How silvery-thread moss responds to carfentrazone-ethyl
Study date
21 April 2025
Authorising party
Public
Auth party contact address
-
Data no
286521
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
Dose responses of silvery-thread moss (Bryum argenteum) to carfentrazone-ethyl
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
286522
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
How silvery-thread moss responds to carfentrazone-ethyl
Study date
October 2024
Authorising party
Public
Auth party contact address
-
Data no
286523
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
Dose Responses of Silvery-thread Moss to Carfentrazone-ethyl
Study date
January 2015
Authorising party
Public
Auth party contact address
-
Data no
286515
Author
Turf Culture P/L
Title
Rates vs Products vs Commerciality
Study date
30 April 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286516
Author
FMC Corporation
Title
Quicksilver T&O Herbicide - USA label
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
286517
Author
FMC Corporation
Title
Best Management Practises - Silvery Threads Moss
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
286518
Author
Turf Culture P/L
Title
Turf Culture Smackdown NZ Moss & Broadleaf Herbicide - Label
Study date
16 November 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286514
Author
Turf Culture Pty Ltd
Title
Evaluation of the Phytotoxic Potential of TC-009, TC-010, TC-011 and Coliseum on several warm and cool season turfgrass varieties.
Study date
14 January 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Date

Application Date

Application No

Application Number

148434
Product/Active constituent Name

Application Product Name

Loveland Genwet 1000

Application details

Product name:

Loveland Genwet 1000

Product number:

89018

Applicant Name:

Loveland Products Inc

Application purpose and description of use:

Variation to update the label as per APVMA issued item 13 letter to include DIETHYLENE GLYCOL MONOBUTYL ETHER in the contstituent statement.

Active constituents:

Active constituent name
63895 - NON-IONIC ALKOXYLATED ALCOHOL

Description of data provided:

Data no
286498
Author
APVMA
Title
Invitation to Submit Item 13 Application
Study date
8 May 2025
Authorising party
APVMA
Date

Application Date

Application No

Application Number

148377
Product/Active constituent Name

Application Product Name

Rodenox 25 Rodenticide Blocks

Application details

Product name:

Rodenox 25 Rodenticide Blocks

Applicant Name:

AUSTRALIAN AGRIBUSINESS (HOLDINGS) PTY LTD

Application purpose and description of use:

Registration of a 0.025 g/kg Difenacoum Rodenticide Block Bait for control of mice and rats in and around domestic buildings and commercial premises.
Date

Application Date

Application No

Application Number

148374
Product/Active constituent Name

Application Product Name

Gnaw Rodenticide Pellets

Application details

Product name:

Gnaw Rodenticide Pellets

Product number:

96155

Applicant Name:

VOLMAC PTY LTD

Application purpose and description of use:

Registration of a 0.75 g/kg cholecalciferol bait product for control of introduced rodents.

Reference details:

94661 - Gnaw Rodenticide

Active constituents:

Active constituent name
94872 - Cholecalciferol

Description of data provided:

Data no
286492
Author
APVMA
Title
Efficacy and Safety Technical Report
Study date
25/09/2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286486
Author
Y Wu
Title
Cholecalciferol Rodenticide Specification
Study date
January 2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286489
Author
Y Wu
Title
Storage stability test report of 0.075% cholecalciferol bait
Study date
August 2014
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286483
Author
Y Wu
Title
Certificate of Analysis
Study date
06/08/2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286484
Author
Y Wu
Title
Information on ingredients
Study date
January 2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286487
Author
Y Wu
Title
Method Verification
Study date
January 2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286490
Author
Volmac Pty Ltd
Title
Gnaw Rodenticide
Study date
4/10/2023
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286482
Author
C Whitney
Title
Permit to import conditionally non-prohibited goods.
Study date
18/07/2023
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286493
Author
F Johnston
Title
Gnaw Rodenticide 94661/143128
Study date
28/10/2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286488
Author
Y Wu
Title
Storage stability test report of 0.075% cholecalciferol bait
Study date
April 2023
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286491
Author
F Johnston
Title
Part 2 Summary
Study date
April 2025
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Data no
286485
Author
Y Wu
Title
0.075% cholecalciferol bait manufacturing process
Study date
January 2024
Authorising party
Applicant
Auth party contact address
42 Newmarket street HENDRA Australia
Date

Application Date

Application No

Application Number

148332
Product/Active constituent Name

Application Product Name

Wagg & Purr Broad-spectrum Allwormer Tablets for Dogs & Puppies

Application details

Product name:

Wagg & Purr Broad-spectrum Allwormer Tablets for Dogs & Puppies

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of a 542 mg oxantel embonate, 143 mg pyrantel embonate, 50 mg praziquantel oral tablet product for the treatment of Roundworm, Hookworm, Whipworm, Tapeworm, plus Hydatid Tapeworm.
Date

Application Date

Application No

Application Number

148010
Product/Active constituent Name

Application Product Name

Intersmooth 7200SI SPC Antifouling

Application details

Product name:

Intersmooth 7200SI SPC Antifouling

Product number:

96042

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of a Copper present as CUPROUS OXIDE 620 - 685 g/L / COPPER PYRITHIONE 37 - 41 g/L / ZINEB 37 - 41 g/L Antifouling Paint for use to control marine growth below the waterline on vessels.

Reference details:

82066 - Interswift 6800HS Tin Free SPC Antifouling

Active constituents:

Active constituent name
58181 - COPPER PYRITHIONE
Active constituent name
51408 - ZINEB

Description of data provided:

Data no
285503
Author
Andrew Beaumont, Chris Wilson
Title
Intersmooth 7200Si Antifouling Paint: Physico-Chemical Properties, Including Accelerated Storage Stability
Study date
November 2022
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285506
Author
Shaun Mizis
Title
Chemistry Manufacture and End Use (Product).
Study date
January 2025
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285507
Author
Shaun Mizis
Title
Environmental Assessment ??? Leaching Behaviour
Study date
January 2025
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285504
Author
Akzo Nobel Pty Ltd BU M&PC Regulatory Affairs
Title
Intersmooth?? 7200Si SPC Antifouling Efficacy Report
Study date
April 2023
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285505
Author
Shaun Mizis
Title
Occupational Health and Safety Information (Product)
Study date
December 2024
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285511
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute DermalToxicity (Limit) Test in Rats
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285513
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute Eye Irritation Test in Rabbits
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285509
Author
Lori Caret B.A.
Title
Interswift 655 Acute Inhalation Toxciity Study in Rats
Study date
30/12/2003
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285510
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute Oral Toxicity (Acute Toxic Class) Test in Rats
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285512
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute Dermal Irritation Test in Rabbits
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285514
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Buehler test in guinea pigs for delayed skin sensitisation potential
Study date
21/03/2003
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285508
Author
Shaun Mizis
Title
Toxicity Data waiver in support of registration of Intersmooth 7200Si
Study date
January 2025
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Date

Application Date

Application No

Application Number

148338
Product/Active constituent Name

Application Product Name

Agro-Essence Thiamethoxam Insecticide Seed Dressing

Application details

Product name:

Agro-Essence Thiamethoxam Insecticide Seed Dressing

Product number:

94183

Applicant Name:

AGRO-ALLIANCE (AUSTRALIA) PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add additional usages.

Active constituents:

Active constituent name
93007 - thiamethoxam

Description of data provided:

Data no
286460
Author
Anon
Title
Evaluation of Agro-Essence Thiamethoxam 350 Insecticide Seed Dressing for the Control of Insects and Tolerance of Sunflower.
Study date
12/03/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
286461
Author
Anon
Title
Evaluate Agro-Essence Thiamethoxam 350 Insecticide Seed Dressing for the Control of Stored Pests in Wheat.
Study date
12/03/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
286462
Author
Anon
Title
Evaluate Agro-Essence Thiamethoxam 350 Insecticide Seed Dressing for the Control of Insects and Tolerance of Cotton.
Study date
14/02/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
286463
Author
Anon
Title
Evaluate Agro-Essence Thiamethoxam 350 Insecticide Seed Dressing when applied to Canola for the control of Aphids
Study date
07/04/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
290635
Author
Anon
Title
Evaluate Agro-Essence Thiamethoxam Insecticide Seed Dressing for the Control of Stored Pests in Oats.
Study date
23/06/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
286464
Author
Anon
Title
Part 8
Study date
2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
290634
Author
Anon
Title
Scientific argument
Study date
15/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Date

Application Date

Application No

Application Number

148053
Product/Active constituent Name

Application Product Name

Firocoxib

Application details

Product name:

Firocoxib

Active name:

Firocoxib

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

New source of active constituent
Date

Application Date

Application No

Application Number

148265
Product/Active constituent Name

Application Product Name

NAADCO Clethodim 240 Herbicide

Application details

Product name:

NAADCO Clethodim 240 Herbicide

Product number:

96131

Applicant Name:

NEW AUSTRALIA AGRICULTURAL DEVELOPMENT COMPANY PTY LTD

Application purpose and description of use:

Registration of a 240g/L Clethodim product for emulsifiable concentrate product for control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans as per the Directions for Use table in the leaflet.

Reference details:

90211 - ACCP Clethodim 240 Herbicide

Active constituents:

Active constituent name
60030 - CLETHODIM
Date

Application Date

Application No

Application Number

148320
Product/Active constituent Name

Application Product Name

Nufarm CRUCIAL Herbicide

Application details

Product name:

Nufarm CRUCIAL Herbicide

Product number:

86761

Applicant Name:

NUFARM AUSTRALIA LIMITED

Application purpose and description of use:

Variation of the label approval to make minor label updates (e.g product names and cross-labelling instructions).

Active constituents:

Active constituent name
65851 - GLYPHOSATE
Active constituent name
64412 - GLYPHOSATE

Description of data provided:

Data no
286324
Author
K Lock
Title
Executive Summary
Study date
April 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286325
Author
Nufarm
Title
Marked up label
Study date
April 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286326
Author
Nufarm
Title
Clean label
Study date
April 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date

Application Date

Application No

Application Number

147989
Product/Active constituent Name

Application Product Name

DEFINE 250 EC Fungicide

Application details

Product name:

DEFINE 250 EC Fungicide

Applicant Name:

CENTRIS SOLUTIONS PTY LTD

Application purpose and description of use:

Registration of a 250 g/L DIFENOCONAZOLE, EMULSIFIABLE CONCENTRATE product for the control of target spot of potatoes and tomatoes, leaf blight of carrots, leaf spot diseases of bananas and husk spot on macadamias as specified in the Directions for Use table.
Date

Application Date

Application No

Application Number

148537
Product/Active constituent Name

Application Product Name

BAYMEC GOLD INJECTION BROAD SPECTRUM ENDECTOCIDE FOR DAIRY AND BEEF CATTLE

Application details

Product name:

BAYMEC GOLD INJECTION BROAD SPECTRUM ENDECTOCIDE FOR DAIRY AND BEEF CATTLE

Product number:

64596

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to update product label.

Active constituents:

Active constituent name
84117 - Clorsulon
Date

Application Date

Application No

Application Number

148253
Product/Active constituent Name

Application Product Name

SUREFIRE ANTSTAR GRANULAR INSECTICIDE

Application details

Product name:

SUREFIRE ANTSTAR GRANULAR INSECTICIDE

Product number:

67014

Applicant Name:

PCT HOLDINGS PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend the range of treated ant species to include Red Imported Fire Ants.

Reference details:

59354 - RICHGRO ANT KILLA

Active constituents:

Active constituent name
59942 - BIFENTHRIN

Description of data provided:

Data no
289196
Author
S Kleinschmidt
Title
A field efficacy evaluation of SureFire Antstar? Granular Insecticide for the control of populations of the Red Imported Fire Ant (Solenopsis invicta) Yatala Farm, QLD
Study date
April 2025
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
289197
Author
S Kleinschmidt
Title
A field efficacy evaluation of SureFire Antstar? Granular Insecticide for the control of populations of the Red Imported Fire Ant (Solenopsis invicta) Corridor Sands, QLD
Study date
April 2025
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
289198
Author
S Kleinschmidt
Title
A field efficacy evaluation of SureFire Antstar? Granular Insecticide for the control of populations of the Red Imported Fire Ant (Solenopsis invicta) Marks Hill, QLD
Study date
April 2025
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
289199
Author
S Kleinschmidt
Title
A field efficacy evaluation of SureFire Antstar? Granular Insecticide for the control of populations of the Red Imported Fire Ant (Solenopsis invicta) Larissa Place, QLD
Study date
April 2025
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
286204
Author
S Kleinschmidt
Title
A field efficacy evaluation of SureFire Antstar Granular Insecticide for the control of populations of the Red Imported Fire Ant (Solenopsis invicta)
Study date
April 2025
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
286205
Author
R Murray
Title
Part 8 Summary
Study date
April 2025
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
286203
Author
APVMA
Title
Pre-Application assistance (PAA) - APVMA written assistance
Study date
19/12/2024
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Date

Application Date

Application No

Application Number

148512
Product/Active constituent Name

Application Product Name

Vetemex 10 mg/mL Injection for Dogs and Cats

Application details

Product name:

Vetemex 10 mg/mL Injection for Dogs and Cats

Product number:

93514

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Variation of product registration to amend the registered product particulars.

Active constituents:

Active constituent name
93579 - Maropitant

Description of data provided:

Data no
294550
Author
Anon
Title
Annex_Process validation
Study date
Mar 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
286351
Author
Anon
Title
Stability report - 15G165 & 15G209
Study date
Nov 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
286352
Author
Anon
Title
Stability results - 19J254
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
294548
Author
Virbac (Australia) Pty Ltd
Title
Cover letter
Study date
Oct 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
294549
Author
Anon
Title
s159 reponse
Study date
Sep 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
286350
Author
A Holdsworth
Title
Executive summary
Study date
May 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
294551
Author
Anon
Title
EMA Guideline 3AQ11a
Study date
Jun 1992
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148325
Product/Active constituent Name

Application Product Name

IMTRADE TAPER 160 VeripHy EC HERBICIDE

Application details

Product name:

IMTRADE TAPER 160 VeripHy EC HERBICIDE

Product number:

96143

Applicant Name:

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 160g/L SAFLUFENACIL emulsifiable concentrate product for the control of a range of broadleaf weeds prior to establishment of crops and forestry plantations, fallows, established citrus, pome and almond orchards, and around commercial, industrial and agricultural buildings and yards, and harvest-aid application in pulse crops as per the Directions for Use table.

Reference details:

91459 - SIERRA HERBICIDE
92673 - IMTRADE TAPER 700 WG HERBICIDE

Active constituents:

Active constituent name
95134 - SAFLUFENACIL

Description of data provided:

Data no
286364
Author
N/A
Title
Imtrade Saflufenacil 160 VeripHy EC Method Validation July 2024
Study date
26/07/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286363
Author
N/A
Title
Imtrade Saflufenacil 160 VeripHy EC 1B Analysis July 2024
Study date
26/07/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286361
Author
N/A
Title
Method of Manufacture - Imtrade Saflufenacil 160 VeripHy EC Herbicide
Study date
30/07/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286365
Author
N/A
Title
Safety Data Sheets
Study date
14/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286366
Author
N/A
Title
CoA - Saflufenacil Tech
Study date
23/01/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286362
Author
N/A
Title
Imtrade Saflufenacil 160 VeripHy EC Herbicide Formulation & Supporting Report
Study date
12/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286367
Author
N/A
Title
Investigation of the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE for the control of weeds in Fallow and Equivalence to IMTRADE TAPER?? 700 WG HERBICIDE. - One Trial, Septimus QLD.
Study date
17/12/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286368
Author
N/A
Title
Investigation into the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE and Equivalence to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in Fallow. ??? One Trial, Cunderdin WA.
Study date
11/12/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286369
Author
N/A
Title
Investigation into the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE and Equivalence to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in Fallow in combination with Paraquat. ??? One Trial, Cunderdin WA.
Study date
10/12/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286370
Author
N/A
Title
Investigation of the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE compared to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in Fallow. - One Trial, Meandarra QLD.
Study date
16/10/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286371
Author
N/A
Title
Investigation into the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE and comparison to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in Fallow. - One Trial, Allinga SA.
Study date
03/03/205
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286372
Author
N/A
Title
Investigation into the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE compared to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in a Lemon cv. Eureka Orchard. - One Trial, Childers QLD.
Study date
20/12/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286373
Author
N/A
Title
Investigation into the Efficacy and Safety of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE and comparison to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in Orange cv. Navel Orchards. - One Trial, Sunlands SA.
Study date
25/02/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286374
Author
N/A
Title
Investigation into the Efficacy and Safety of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE and comparison to IMTRADE TAPER?? 700 WG HERBICIDE for the control of weeds in Almond cv. Nopareil Orchard. - One Trial, Allinga SA.
Study date
01/03/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286375
Author
N/A
Title
Investigation of the Bio-equivalence of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE to that of SIERRA HERBICIDE as a Harvest Aid for the desiccation of Narrow Leaf Lupin cv. Gunyidi. ??? One Trial, Lake King WA.
Study date
25/02/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286376
Author
N/A
Title
Investigation of the Bio-equivalence of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE to that of SIERRA HERBICIDE as a Harvest Aid for the desiccation of Faba Beans cv. Fiesta. ??? One Trial, Lake King WA.
Study date
28/02/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286377
Author
N/A
Title
Investigation of the Efficacy of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE as an aid to Harvest in Chickpea cv. Kyabra and Equivalency to SIERRA HERBICIDE. - One Trial, Manapouri QLD.
Study date
13/12/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286378
Author
N/A
Title
Investigation into the Bio-equivalence of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE compared to SIERRA HERBICIDE as a Harvest Aid in Lentil cv. Thunder. - One Trial, Roseworthy SA.
Study date
27/03/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286379
Author
N/A
Title
Investigation of the Bio-equivalence of IMTRADE TAPER?? 160 VeripHy?? EC HERBICIDE to that of SIERRA HERBICIDE as a Harvest Aid for the desiccation of Field Peas cv. Gunya. ??? One Trial, Lake King WA.
Study date
2/02/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
286380
Author
N/A
Title
Comments to Support Efficacy and Host Crop Safety data submitted
Study date
29/04/2025
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date

Application Date

Application No

Application Number

148372
Product/Active constituent Name

Application Product Name

Flupyradifurone

Application details

Product name:

Flupyradifurone

Active name:

Flupyradifurone

Applicant Name:

SHANGHAI E-TONG CHEMICAL CO LTD

Application purpose and description of use:

Approval of Flupyradifurone for use in agricultural chemical products.

Description of data provided:

Data no
286385
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Residual Solvent Test of Flupyradifurone Technical
Study date
2022
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291950
Author
Anon.
Title
CIPAC MT 30.5. M-029541-01-1
Study date
2001-01-09
Authorising party
Public
Auth party contact address
-
Data no
291951
Author
Etzel, W.; Schlemmer, H. P.
Title
Identification of substances by NMR (1H, 13C, 19F, 31P). M-267381-03-2
Study date
2009-10-28
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291952
Author
Buhl, W.; Beyer, M.
Title
Fluopyram ( AE C656948 ) - Determination of technical grade active substance HPLC with external standard. M-441895-01-1
Study date
2012-11-20
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291953
Author
Buhl, W.; Beyer, M.
Title
Validation of AM020212MP1 - Fluopyram ( AE C656948 ) - Determination of technical grade active substance. M-449611-01-1
Study date
2013-03-19
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291954
Author
Hauser, M.; Remahagen, I.
Title
Determination of sodium, chloride, fluoride and sulfate in fluopyram. M-461694-01-1
Study date
2013-05-28
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291955
Author
Hauser, M.
Title
Amendment no. 1 - Validation of AM022513MP1 - Fluopyram (AE C656948) Impurities in technical grade active substance - IC-external standard. M-462436-02-1
Study date
2014-09-24
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291956
Author
Buhl, W.; Uroic, K.
Title
Fluopyram ( AE C656948 ) - Impurities in technical grade active substance - HPLC with external standard. M-481593-03-1
Study date
2014-07-27
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291957
Author
Uroic, K.
Title
Amendment no.1 - Validation of AM003906MP5 - Fluopyram ( AE C656948 ) - Impurities in technical grade active substance - HPLC with external standard
Study date
2015-07-29
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291958
Author
Hauser, M.; Kraemer, F.
Title
Validation of GLC-method AM028717MP1. M-588376-01-1
Study date
2017-05-11
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291959
Author
Hauser, M.; Kraemer, F.
Title
Determination of methanol, tert.-butylmethylether, toluene and methylcylohexane in technical grade active substance fluopyram ( AE C656948) GLC- headspace - external standard. M-588380-01-1
Study date
2017-04-05
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291960
Author
Frensemeier, L.
Title
Material accountability of technical fluopyram. M-609783-02-1
Study date
2017-12-13
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286388
Author
WHO
Title
Flupyradifurone WHO Specifications For Public Health Pesticides
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
291964
Author
Woehrmann, H.
Title
Certificate of Analysis. M-878793-01-1
Study date
2025-05-20
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286384
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Five Batches Analysis of Flupyradifurone TGAI
Study date
2020
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
292393
Author
SHANGHAI E-TONG CHEMICAL CO., LTD
Title
Flupyradifurone Technical Certificate of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286387
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Certificates of Analysis and QA Support
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291963
Author
Woehrmann, H.
Title
Fluopyram technical active substance - discussion of formation of impurities. M-878437-01-2
Study date
2025-05-20
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286383
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Description Of Manufacturing Process Of Flupyradifurone And Impurity Information
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291961
Author
Woehrmann, H.
Title
Description of the manufacturing process of the technical grade active substance fluopyram for Australia. M-878435-01-1
Study date
2025-04-29
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291962
Author
Woehrmann, H.
Title
Certificate of composition. M-878436-01-2
Study date
2025-05-20
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286382
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Part 2 Chemistry and Manufacturing
Study date
2024
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286386
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Flupyradifurone Declaration of Composition (DoC)
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286389
Author
JMPR
Title
Flupyradifurone CODEX assessment report (285)
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
286390
Author
Shanghai E-Tong Chemical Co., Ltd
Title
SDS
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
286391
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Etong Flupyradifurone TGAC EU approval notice
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291949
Author
Fitzgerald, M.
Title
Chemistry
Study date
2025-08-27
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
291965
Author
Woehrmann, H.
Title
Statement on fluopyram technical material for Australia. M-878931-01-1
Study date
2025-05-27
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
292389
Author
SHANGHAI E-TONG CHEMICAL CO LTD
Title
RE. S159 NOTICE RESPONSE FROM SHANGHAI E-TONG CHEMICAL CO., LTD
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
292392
Author
SHANGHAI E-TONG CHEMICAL CO., LTD
Title
BACTERIAL REVERSE MUTATION TEST OF FLUPYRADIFURONE (As per OECD Guideline No. 471: Bacterial Reverse Mutation Test)
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
292390
Author
SHANGHAI E-TONG CHEMICAL CO., LTD
Title
QSAR analysis for flupyradifurone and the related metabolites of Impurity 1
Study date
2025
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
292391
Author
European Food Safety Authority (EFSA)
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance flupyradifurone.
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
292394
Author
European Commission (EC)
Title
Draft Assessment Report and Proposed Decision of the Netherlands prepared in the context of the possible inclusion of flupyradifurone in Regulation (EU) 1107/2009. January 2014.
Study date
2009
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148052
Product/Active constituent Name

Application Product Name

Dechra Firocoxib 57mg Tablets

Application details

Product name:

Dechra Firocoxib 57mg Tablets

Product number:

96063

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

Registration of a 57mg/tablet firocoxib tablet product for relief of pain and control of inflammation associated with osteoarthritis and other musculo-skeletal disorders. Also indicated for the control of post-operative pain associated with surgery; including soft tissue, orthopaedic and dental procedures.

Reference details:

58093 - PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL

Active constituents:

Active constituent name
96064 - Firocoxib

Description of data provided:

Data no
284993
Author
Anonymous
Title
Firocoxib Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284991
Author
Anonymous
Title
Active Substance Master File - part 1
Study date
May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284992
Author
Anonymous
Title
Active Substance Master File - part 2
Study date
May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284995
Author
G Fallon, J Gleave
Title
ASTM001
Study date
19 May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284996
Author
G Fallon, J Gleave
Title
ASTM002
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284997
Author
G Fallon, J Gleave
Title
ASTM003
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284998
Author
G Fallon, J Gleave
Title
ASTM009
Study date
20 October 2020
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284999
Author
G Fallon, J Gleave
Title
ASTM010
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285000
Author
British Pharmacopoeial Comission
Title
Appendix XVI B. Microbiological Examination of Non-sterile Products
Study date
1 January 2025
Authorising party
Public
Auth party contact address
-
Data no
285001
Author
U Lama, L van Rensburg
Title
ASTM211
Study date
5 September 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285002
Author
U Lama, G Fallon, L Van Rensburg
Title
AMVP23_01
Study date
4 September 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285003
Author
G Fallon, L van Rensburg
Title
LS-AMYPLAIN Ed 06
Study date
27 Feb 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284994
Author
Dechra Veterinary Products (Australia) Pty Ltd (Ed)
Title
Excipient Monographs and Certificates of Analysis
Study date
December 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284990
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Module 2.3 - Chemistry and Manufacture
Study date
February 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285004
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Module 8.3 - Efficacy and Safety
Study date
February 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285005
Author
P Phuwapattanachart, N Thengchaisri
Title
Analgesic efficacy of oral firocoxib in ovariohysterectomized cats
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
285006
Author
L Tsirulnikov
Title
KFl-056-KC-3316
Study date
8 June 2017
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285007
Author
C Chark
Title
KFl-056-BC-4118
Study date
5 March 2019
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285009
Author
H Chambers
Title
DEC C 24035 W
Study date
31 January 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285008
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Pre-application assistance (PAA) - meeting record and advice
Study date
2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia