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
146678
Product/Active constituent Name
Application Product Name
Clorsulon
Application Date
Application Number
146678
Application Product Name
Clorsulon
Application details
Product name:
Clorsulon
Active name:
Clorsulon
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Clorsulon for use in veterinary chemical products.
Description of data provided:
Data no
281302
Title
Certificate of analysis
Study date
20/12/2023
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
281303
Title
Certificate of analysis
Study date
21/12/2023
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
281304
Title
Certificate of analysis
Study date
22/12/2023
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
285565
Title
Certificate of Analysis 70625002
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
285566
Title
Certificate of Analysis 70625001
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
285567
Title
Certificate of Analysis 70625003
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
146727
Product/Active constituent Name
Application Product Name
Fenbendazole
Application Date
Application Number
146727
Application Product Name
Fenbendazole
Application details
Product name:
Fenbendazole
Active name:
Fenbendazole
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Fenbendazole for use in veterinary chemical products.
Description of data provided:
Data no
281460
Title
Certificate of analysis
Study date
24/03/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
281461
Title
Certificate of analysis
Study date
27/03/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
281462
Title
Certificate of analysis
Study date
30/03/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
284936
Title
s159 response
Study date
27/03/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
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 Date
Application Number
145873
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
Title
Import permit
Study date
Feb 2022
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 Date
Application Number
146379
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 Date
Application Number
146542
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
Title
Application Overview and Safety Data Sheets
Study date
26 November 2024
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 Date
Application Number
146711
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 Date
Application Number
145876
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
Title
Import permit
Study date
Feb 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
284542
Title
20250324 Response to s159 Notice
Study date
March 2025
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 Date
Application Number
146449
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
Title
Qualitative and Quantitative Profile of Prothioconazole Technical (Five-Batch Analysis)
Study date
24 July 2024
Data no
281064
Title
Manufacturing Process
Study date
September 2024
Data no
281065
Title
Declaration of Composition
Study date
30 September 2024
Data no
281067
Title
Prothioconazole Technical
Study date
November 2024
Data no
281063
Title
Executive Summary
Study date
November 2024
Date
Application Date
Application No
Application Number
146530
Product/Active constituent Name
Application Product Name
Quantum Haloxyfop 520EC Herbicide
Application Date
Application Number
146530
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 Date
Application Number
146527
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 Date
Application Number
146592
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
Title
Efficacy Dossier
Study date
Dec 2024
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Data no
281342
Title
Crop safety and bioequivalence
Study date
Oct 2024
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 Date
Application Number
145841
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
Title
Active Certificates of analysis
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
280170
Title
Active Certificates of analysis
Study date
2024
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 Date
Application Number
146529
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 Date
Application Number
146382
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 Date
Application Number
146272
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 Date
Application Number
146712
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 of product registration to make a minor change to formulation.
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
Title
Finished product specification
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
281435
Title
Registered formulation
Study date
1996
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 Date
Application Number
145840
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
Title
Appendix 1: FENSTAR 100 Oral Drench for Cattle & Horses - Revised Technical Information
Study date
22 February 2025
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
279467
Title
Finished Product Specs
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145706
Product/Active constituent Name
Application Product Name
EQUIMECT ROUNDWORM, BOT & TAPEWORM ORAL PASTE FOR HORSES
Application Date
Application Number
145706
Application Product Name
EQUIMECT ROUNDWORM, BOT & TAPEWORM ORAL PASTE FOR HORSES
Application details
Product name:
EQUIMECT ROUNDWORM, BOT & TAPEWORM ORAL PASTE FOR HORSES
Product number:
95448
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
Registration of EQUIMECT (4 g/kg of Ivermectin and 50 g/kg Praziquantel) Oral Paste product for Horses.
EQUIMECT kills the adult and larval stages of the important internal parasites of horses.These include tapeworms, small redworms that may be resistant to benzimidazole-based wormers, the large redworm including its arterial stages, lungworms, bots, summer sores and cutaneous onchocerciasis*.
Reference details:
59407 - IVERQUANTEL ROUNDWORM, BOT AND TAPEWORM ORAL PASTE FOR HORSES
Active constituents:
Active constituent name
95449 - Ivermectin
Active constituent name
95450 - Praziquantel
Description of data provided:
Data no
279036
Title
Finished Product Specs
Study date
2024
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 Date
Application Number
145708
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
Title
Active Certificates of analysis
Study date
2024
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 Date
Application Number
145709
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
Title
Active Certificates of analysis
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand