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

145873
Product/Active constituent Name

Application Product Name

ELANCO AH0513 COMPONENT TE-200 WITH TYLAN GROWTH AND FINISHING IMPLANTS FOR HEIFERS AND STEERS

Application details

Product name:

ELANCO AH0513 COMPONENT TE-200 WITH TYLAN GROWTH AND FINISHING IMPLANTS FOR HEIFERS AND STEERS

Product number:

62874

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of finished product registration to make a minor amendment to the product and label name, reflect the TGA naming convention, and variation of the label approval to align with vet labeling code and amend a historical statement in the label.

Active constituents:

Active constituent name
83107 - OESTRADIOL
Active constituent name
84070 - Trenbolone acetate
Active constituent name
85274 - OESTRADIOL
Active constituent name
87584 - Tylosin Tartrate

Description of data provided:

Data no
279822
Author
Anon
Title
Import permit
Study date
Feb 2022
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

146379
Product/Active constituent Name

Application Product Name

TERMINATOR BROAD SPECTRUM DISINFECTANT

Application details

Product name:

TERMINATOR BROAD SPECTRUM DISINFECTANT

Product number:

51744

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Update label of an approved agricultural chemical to comply with the current Ag Labelling Code.

Active constituents:

Active constituent name
44432 - GLUTARALDEHYDE
Active constituent name
44027 - GLUTARALDEHYDE
Date

Application Date

Application No

Application Number

146542
Product/Active constituent Name

Application Product Name

DUAL GOLD HERBICIDE

Application details

Product name:

DUAL GOLD HERBICIDE

Product number:

50477

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to seek approval for alternative inert ingredient and update manufacturing site details.

Active constituents:

Active constituent name
44437 - S-METOLACHLOR

Description of data provided:

Data no
281578
Author
Sison, M.
Title
Application Overview and Safety Data Sheets
Study date
26 November 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

146711
Product/Active constituent Name

Application Product Name

Purina TotalCare Allwormer Protection for Cats & Kittens

Application details

Product name:

Purina TotalCare Allwormer Protection for Cats & Kittens

Product number:

69530

Applicant Name:

NESTLE PURINA PETCARE A DIV OF NESTLE AUSTRALIA LTD

Application purpose and description of use:

Variation of the label approval to update the label in accordance with the Veterinary Labelling Code.
Date

Application Date

Application No

Application Number

145876
Product/Active constituent Name

Application Product Name

ELANCO AH0973 COMPONENT TE-S WITH TYLAN GROWTH AND FINISHING IMPLANTS FOR STEERS

Application details

Product name:

ELANCO AH0973 COMPONENT TE-S WITH TYLAN GROWTH AND FINISHING IMPLANTS FOR STEERS

Product number:

62873

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of finished product registration to make a minor amendment to the product and label name, reflect the TGA naming convention, and variation of the label approval to align with vet labeling code and amend a historical statement in the label.

Active constituents:

Active constituent name
83107 - OESTRADIOL
Active constituent name
84070 - Trenbolone acetate
Active constituent name
85274 - OESTRADIOL
Active constituent name
87584 - Tylosin Tartrate

Description of data provided:

Data no
279823
Author
Anon
Title
Import permit
Study date
Feb 2022
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
284542
Author
Elanco Australasia Pty Ltd
Title
20250324 Response to s159 Notice
Study date
March 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

146449
Product/Active constituent Name

Application Product Name

Prothioconazole

Application details

Product name:

Prothioconazole

Active name:

Prothioconazole

Applicant Name:

HUNAN BIDE BIOCHEMICAL TECHNOLOGY CO LTD

Application purpose and description of use:

Approval of Prothioconazole for use in agricultural chemical products.

Description of data provided:

Data no
281066
Author
Natalia Tagliacozzi Galvao
Title
Qualitative and Quantitative Profile of Prothioconazole Technical (Five-Batch Analysis)
Study date
24 July 2024
Authorising party
Applicant
Data no
281064
Author
Anon
Title
Manufacturing Process
Study date
September 2024
Authorising party
Applicant
Data no
281065
Author
Yaoqiu Liu
Title
Declaration of Composition
Study date
30 September 2024
Authorising party
Applicant
Data no
281067
Author
Anon
Title
Prothioconazole Technical
Study date
November 2024
Authorising party
Applicant
Data no
281063
Author
Anon
Title
Executive Summary
Study date
November 2024
Authorising party
Applicant
Date

Application Date

Application No

Application Number

146530
Product/Active constituent Name

Application Product Name

Quantum Haloxyfop 520EC Herbicide

Application details

Product name:

Quantum Haloxyfop 520EC Herbicide

Product number:

95620

Applicant Name:

QUANTUM AGROSCIENCES HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 520 g/L HALOXYFOP present as the haloxyfop-P methyl ester Emulsifiable Concentrate product for the post-emergent control of a wide range of annual and perennial grass weeds in grain legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops as specified in the directions for use..

Reference details:

60648 - HALOXY 520 HERBICIDE

Active constituents:

Active constituent name
90582 - Haloxyfop-p-methyl
Date

Application Date

Application No

Application Number

146527
Product/Active constituent Name

Application Product Name

Quantum Azoxystrobin 250SC Fungicide

Application details

Product name:

Quantum Azoxystrobin 250SC Fungicide

Product number:

95617

Applicant Name:

QUANTUM AGROSCIENCES HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 250 g/L Azoxystrobin Suspension Concentration product for the control of various diseases Almonds, Anise Myrtle, Avocados, Beans, Brassicas, Carrot, Citrus, Cucurbits, Cut Flowers/Foliage, Garlic, Grapes, Horse radish, Leeks, Lemon Myrtle, Lettuce, Mangoes, Nursery stock, Olives, Ornamentals, Passionfruit, Pistachio, Poppies, Potatoes, Pyrethrum, Radish, Riberries, Rubus Crops, Shallots, Spring Onions and Tomatoes per the Directions for Use.

Reference details:

67741 - Kingstar 250 Fungicide

Active constituents:

Active constituent name
70105 - AZOXYSTROBIN
Date

Application Date

Application No

Application Number

146592
Product/Active constituent Name

Application Product Name

Sabakem Azoxystrobin 250 SC Fungicide

Application details

Product name:

Sabakem Azoxystrobin 250 SC Fungicide

Product number:

91142

Applicant Name:

SABAKEM PTY LTD

Application purpose and description of use:

Variation of the label to add use in almonds.

Active constituents:

Active constituent name
64692 - AZOXYSTROBIN
Active constituent name
64896 - AZOXYSTROBIN
Active constituent name
66953 - AZOXYSTROBIN
Active constituent name
67359 - AZOXYSTROBIN
Active constituent name
68562 - AZOXYSTROBIN
Active constituent name
68881 - AZOXYSTROBIN

Description of data provided:

Data no
281341
Author
Anon
Title
Efficacy Dossier
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Data no
281342
Author
Anon
Title
Crop safety and bioequivalence
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date

Application Date

Application No

Application Number

145841
Product/Active constituent Name

Application Product Name

Fenbendazole (EP)

Application details

Product name:

Fenbendazole (EP)

Active name:

Fenbendazole (EP)

Applicant Name:

AURA LABORATORIES LIMITED

Application purpose and description of use:

New source of active constituent.

Description of data provided:

Data no
280169
Author
Anon
Title
Active Certificates of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
280170
Author
Not identified
Title
Active Certificates of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date

Application Date

Application No

Application Number

146529
Product/Active constituent Name

Application Product Name

Quantum Tebuconazole SC Fungicide

Application details

Product name:

Quantum Tebuconazole SC Fungicide

Product number:

95619

Applicant Name:

QUANTUM AGROSCIENCES HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 430 g/L Tebuconazole Suspension Concentrate product for the control of Leaf Spot and Leaf Speckle on Bananas; Rust, Leaf Spot and Net Blotch of Peanuts; Foliar Diseases on Cereal Crops; and Other Diseases on Beans, Peas, Onions, Pawpaw, Pyrethrum and Ryegrass and Fescue Seed Crops.

Reference details:

64019 - RAINBOW TEBUCONAZOLE 430 SC FUNGICIDE

Active constituents:

Active constituent name
66062 - TEBUCONAZOLE
Date

Application Date

Application No

Application Number

146382
Product/Active constituent Name

Application Product Name

METINA Glufosinate 200 (Non-Selective Herbicide)

Application details

Product name:

METINA Glufosinate 200 (Non-Selective Herbicide)

Product number:

95567

Applicant Name:

METINA AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a soluble concentrate formulation containing 200 g/L glufosinate, for non-residual control of broadleaf and grass weeds in various situations.

Reference details:

66325 - HUILONG GLUFOSINATE 200 NON-SELECTIVE HERBICIDE

Active constituents:

Active constituent name
63781 - GLUFOSINATE-AMMONIUM
Active constituent name
61903 - GLUFOSINATE-AMMONIUM
Date

Application Date

Application No

Application Number

146272
Product/Active constituent Name

Application Product Name

Fleece DIP for Sheep

Application details

Product name:

Fleece DIP for Sheep

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

Registration of Fleece DIP for Sheep for the control of neonicotinoid susceptible and IGR resistant strains of body lice Bovicola ovis on short wool sheep.
Date

Application Date

Application No

Application Number

146712
Product/Active constituent Name

Application Product Name

TRICIN EYE & EAR OINTMENT

Application details

Product name:

TRICIN EYE & EAR OINTMENT

Product number:

36220

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation to the relevant particulars of the product registration by changing the concentration of a non-active constituent, and of label by aligning it with the current Veterinary Labelling Code.

Active constituents:

Active constituent name
84094 - Neomycin Sulfate
Active constituent name
54734 - BACITRACIN ZINC
Active constituent name
84332 - POLYMYXIN B SULFATE

Description of data provided:

Data no
281436
Author
Anon
Title
Finished product specification
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
281435
Author
Anon
Title
Registered formulation
Study date
1996
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

145840
Product/Active constituent Name

Application Product Name

FENSTAR 100 ORAL DRENCH FOR CATTLE & HORSES

Application details

Product name:

FENSTAR 100 ORAL DRENCH FOR CATTLE & HORSES

Product number:

95495

Applicant Name:

AURA LABORATORIES LIMITED

Application purpose and description of use:

Registration of a 100g/L Fenbendazole Oral Drench product is proposed for the control of benzimidazole-sensitive mature and immature Roundworms (including inhibited Ostertagia), Lungworms and as an aid in the control of Tapeworms in Cattle. For the treatment and control of Roundworms, Bloodworms, Redworms and Pinworms in horses.

Reference details:

37088 - COOPERS PANACUR 100 ORAL ANTHELMINTIC FOR CATTLE AND HORSES

Active constituents:

Active constituent name
95496 - fenbendazole

Description of data provided:

Data no
284874
Author
Anon
Title
Appendix 1: FENSTAR 100 Oral Drench for Cattle & Horses - Revised Technical Information
Study date
22 February 2025
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
279467
Author
Anon
Title
Finished Product Specs
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
299844
Author
Registrant
Title
Scientific Justifications for Efficacy, Safety and Trade criteria
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date

Application Date

Application No

Application Number

145708
Product/Active constituent Name

Application Product Name

Ivermectin

Application details

Product name:

Ivermectin

Active name:

Ivermectin

Applicant Name:

AURA LABORATORIES LIMITED

Application purpose and description of use:

New source of pharmacopoeia active constituent.

Description of data provided:

Data no
279832
Author
Anon
Title
Active Certificates of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date

Application Date

Application No

Application Number

145709
Product/Active constituent Name

Application Product Name

Praziquantel

Application details

Product name:

Praziquantel

Active name:

Praziquantel

Applicant Name:

AURA LABORATORIES LIMITED

Application purpose and description of use:

New source of pharmacopoeia active constituent.

Description of data provided:

Data no
279838
Author
Anon
Title
Active Certificates of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date

Application Date

Application No

Application Number

145870
Product/Active constituent Name

Application Product Name

TRUMP SPRAY OIL

Application details

Product name:

TRUMP SPRAY OIL

Product number:

59092

Applicant Name:

VICTORIAN CHEMICAL COMPANY PROPRIETARY LIMITED

Application purpose and description of use:

Variation of the label approval to copy uses from closely similar reference products.

Reference details:

58360 - BIOCLEAR PARAFFINIC OIL
84730 - eChem e-Oil Cotton Defoliant Oil
84730 - eChem e-Oil Insecticide and Defoliant Oil
84730 - Parasol Insecticide and Defoliant Oil

Active constituents:

Active constituent name
60259 - PARAFFIN OIL

Description of data provided:

Data no
279820
Author
Peter Jones
Title
Trump label justification for use
Study date
25.10.2024
Authorising party
Applicant
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Date

Application Date

Application No

Application Number

146388
Product/Active constituent Name

Application Product Name

Conquest Preceed 850 WG Herbicide

Application details

Product name:

Conquest Preceed 850 WG Herbicide

Product number:

89148

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Variation of our product registration to extend the use into legumes’

Reference details:

92777 - F.S.A. Pyroxasulfone 850 WG Herbicide

Active constituents:

Active constituent name
88609 - pyroxasulfone

Description of data provided:

Data no
280993
Author
Flora Bavand
Title
Application Overview
Study date
Oct 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
280994
Author
Anon
Title
Appendix 1 - Efficacyy evaluation
Study date
2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
280995
Author
Flora Bavand
Title
Draft label with comments
Study date
Nov 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

146254
Product/Active constituent Name

Application Product Name

PROPALIN

Application details

Product name:

PROPALIN

Product number:

53680

Applicant Name:

VETOQUINOL AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product label approval to amend side-effects and align with Vet Labeling Guideline.

Active constituents:

Active constituent name
55314 - PHENYLPROPANOLAMINE HYDROCHLORIDE

Description of data provided:

Data no
279868
Author
Vetoquinol
Title
Declaration
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 2 485 Kingsford Smith Drive Hamilton Australia
Data no
279869
Author
EMEA
Title
Summary Product Characteristics
Study date
2021
Authorising party
Applicant
Auth party contact address
Level 2 485 Kingsford Smith Drive Hamilton Australia