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
150575
Product/Active constituent Name
Application Product Name
IMTRADE FEDERATE 1000 EC GRAIN PROTECTANT
Application Date
Application Number
150575
Application Product Name
IMTRADE FEDERATE 1000 EC GRAIN PROTECTANT
Application details
Product name:
IMTRADE FEDERATE 1000 EC GRAIN PROTECTANT
Product number:
96747
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 1000g/L FENITROTHION emulsifiable concentrate product for control of grain pests (except Lesser Grain Borer) in stored cereal grain and storage facilities and equipment as specified in the Directions for Use table.
Reference details:
46127 - METHOGRAIN FENITROTHION 1000 INSECTICIDE
Description of data provided:
Data no
295371
Title
Method of Manufacture ??? Imtrade Fenitrothion 1000 EC Insecticide
Study date
02/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295377
Title
Investigation into the Bio-equivalence of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT to that of METHOGRAIN FENITROTHION 1000 INSECTICIDE for the control of Rust Red Flour Beetles in Wheat cv. Scepter grain. ??? One Trial, Kwinana, Western Australia.
Study date
26/04/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295374
Title
Imtrade Fenitrothion 1000 EC Method Validation ??? August 2023
Study date
01/08/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295380
Title
Investigation into the Host Crop Safety of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT to that of METHOGRAIN FENITROTHION 1000 INSECTICIDE as a grain storage treatment applied to Barley cv. Maximus. ??? One Trial, Kwinana, Western Australia.
Study date
18/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295388
Title
APVMA Notice of Proposed Decision for App 94298-142035.pdf
Study date
17/02/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295375
Title
Safety Data Sheets for other Constituents
Study date
14/06/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295383
Title
Investigation into the Host Crop Safety of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT compared to METHOGRAIN FENITROTHION 1000 INSECTICIDE when used stand-alone or in combination as a grain storage treatment for Millet. - One Trial, Kwinana, Western Australia.
Study date
15/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295389
Title
APVMA Notice of Application Withdrawal for App 94298/142035
Study date
18/02/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295372
Title
Formulation and Stability Report - Imtrade Fenitrothion 1000 EC Insecticide
Study date
02/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295386
Title
Comments to Support additional Efficacy and Host Crop Safety Data submitted 19th August, 2024 for Application 94298/142035
Study date
19/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295381
Title
Comments to support Efficacy and Host Crop Safety data submitted
Study date
10/10/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295387
Title
FTR released 23 April 2024 on previous App 94298-142035
Study date
23/04/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295384
Title
Investigation into the Host Crop Safety of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT compared to METHOGRAIN FENITROTHION 1000 INSECTICIDE when used stand-alone or in combination as a grain storage treatment for Barley. - One Trial, Kwinana, Western Australia.
Study date
01/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295378
Title
Investigation into the Bio-equivalence of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT to that of METHOGRAIN FENITROTHION 1000 INSECTICIDE for the control of Rice Weevils in Wheat cv. Scepter grain. ??? One Trial, Kwinana, Western Australia.
Study date
26/04/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295373
Title
Imtrade Fenitrothion 1000 EC 1 Batch Analysis ??? August 2023
Study date
01/08/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295379
Title
Investigation into the Host Crop Safety of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT to that of METHOGRAIN FENITROTHION 1000 INSECTICIDE as a grain storage treatment applied to Wheat cv. Scepter. ??? One Trial, Kwinana, Western Australia.
Study date
18/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295385
Title
Section 159(1)(a) ??? Notice of requirement of information, report or sample issued 22/7/2024 on previous Application 94298/142035 ??? for information.
Study date
22/07/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295376
Title
Argument as to AgVet Chemicals Code Act 1994 - Section 14(3)
Study date
02/10/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
295382
Title
Investigation into the Host Crop Safety of IMTRADE FEDERATE?? 1000 EC GRAIN PROTECTANT compared to METHOGRAIN FENITROTHION 1000 INSECTICIDE when used stand-alone or in combination as a grain storage treatment for Sorghum. ??? One Trial, Kwinana, Western Australia.
Study date
07/08/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
150776
Product/Active constituent Name
Application Product Name
4 Farmers ProMet Gold
Application Date
Application Number
150776
Application Product Name
4 Farmers ProMet Gold
Application details
Product name:
4 Farmers ProMet Gold
Product number:
96820
Applicant Name:
4 FARMERS AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a new herbicide product, ProMet Gold, which is an Emulsifiable Concentrate (EC) formulation containing the active constituents: Prosulfocarb 800 g/L and S-Metolachlor 120 g/L.
ProMet Gold is intended for the pre-emergent and early post-emergent control of annual ryegrass (Lolium rigidum) and other grass and broadleaf weeds in a range of crops, including wheat, barley, chickpeas, faba beans, field peas, lentils, lupins, oats, potatoes, and triticale.
This product is bioequivalent to the already registered product Boxer Gold, demonstrating equivalent efficacy, crop safety, and environmental profile. The application seeks approval of the formulation, packaging, and labelling to enable its legal supply, storage, handling, and use in accordance with the Agvet Code and relevant regulations.
Reference details:
61234 - BOXER GOLD HERBICIDE
Active constituents:
Active constituent name
81031 - PROSULFOCARB
Active constituent name
81731 - 4Farmers S-Metolachlor 960 EC Herbicide
Active constituent name
89819 - S-metolachlor
Description of data provided:
Data no
296330
Title
Validation of method QCM-071 for the assay of actives Prosulfocarb and S-Metolachlor
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296336
Title
Post Emergent Boxer Gold EC Bio-equivalent
Study date
17-09-2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296333
Title
GHS classification of 4Farmers ProMet Gold Herbicide
Study date
2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296327
Title
Chemistry and manufacture of 4Farmers ProMet Gold Herbicide
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296328
Title
Stability Report of 4Farmers ProMet Gold Herbicide
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296331
Title
SDS's of 4Farmers ProMet Gold EC Components
Study date
2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296334
Title
4Farmers Prosulfocarb + S-Metolachlor - Barley
Study date
30-08-2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296332
Title
Certificate of Analysis of the active materials
Study date
2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296329
Title
Analytical GC assay method for Prosulfocarb and S-Metolachlor
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296335
Title
4Farmers Prosulfocarb + S-Metolachlor - Wheat
Study date
30-08-2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date
Application Date
Application No
Application Number
150793
Product/Active constituent Name
Application Product Name
Fluopyram
Application Date
Application Number
150793
Application Product Name
Fluopyram
Application details
Product name:
Fluopyram
Active name:
Fluopyram
Applicant Name:
Foison Scitech Co., Limited
Application purpose and description of use:
Approval of Fluopyram for use in agricultural chemical products.
Description of data provided:
Data no
296682
Title
Fluopyram Technical Synthesis Process
Study date
September 2025
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296685
Title
Fluopyram - Part 2-Chemistry 1125
Study date
October 2025
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296683
Title
DECLARATION OF COMPOSITION
Study date
September 2025
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296681
Title
Fluopyram Executive Summary 1125
Study date
November 2025
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Data no
296684
Title
Determination of Active Content and Impurity Profile of Fluopyram Technical
Study date
October 2025
Auth party contact address
RM 19C Lochart CTR 301-307 Lockart Road Wan Chai Hong Kong
Date
Application Date
Application No
Application Number
150738
Product/Active constituent Name
Application Product Name
Mortein Fast Knockdown Flying Insect Killer
Application Date
Application Number
150738
Application Product Name
Mortein Fast Knockdown Flying Insect Killer
Application details
Product name:
Mortein Fast Knockdown Flying Insect Killer
Product number:
96808
Applicant Name:
RB (HYGIENE HOME) AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.7 g/kg permethrin, 0.5 g/kg transfluthrin aerosol product to kill flying insects in domestic applications.
Active constituents:
Active constituent name
47544 - TRANSFLUTHRIN
Active constituent name
89258 - Permethrin
Description of data provided:
Data no
296250
Title
Peet-Grady Chamber Study to Determine the Knockdown and Kill of Seven Aerosol Formulations against Musca domestica
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296261
Title
Aerosol Spray Test Against German Cockroaches (Knockdown Test)
Study date
22.04.08
Auth party contact address
680 George Street Sydney Australia
Data no
296253
Title
Laboratory study to determine the Direct Spray Knockdown & Kill of Five Aerosol formulations Against the House Fly
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296247
Title
Quantification of Transfluthrin, Imiporthrin and Permethrin in water-based formulations via High-Performance Liquid Chromatography with Ultra-Biolet Detector (HPLC-UV)
Study date
14.11.2024
Auth party contact address
680 George Street Sydney Australia
Data no
296256
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Three Aerosol Formulations against Spiders ??? one Second Spray
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296248
Title
Health Module documents
Study date
16.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296259
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations against Silverfish
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296262
Title
Aerosol Spray Test Against American Cockroaches (Knockdown Test)
Study date
22.04.08
Auth party contact address
680 George Street Sydney Australia
Data no
296254
Title
Aerosol Spray Test against the American Cockroach (Knockdown Test) Results and Report (2 Second Spray)
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296257
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations against a Black Ant
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296251
Title
Peet-Grady Chamber Study to Determine the Knockdown and Kill of Five Aerosol Formulations against Culex quinquefasciatus
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296260
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Two Aerosol formulations Against the Paper Wasp
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296252
Title
Laboratory study to determine the Direct Spray Knockdown & Kill of Five Aerosol formulations Against the Mosquito
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296246
Title
Stability Report ??? Accelerated (2 weeks)
Study date
19.05.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296249
Title
Efficacy Summary
Study date
10.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296255
Title
Aerosol Spray Test against the German Cockroach (Knockdown Test) Results and Report
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296258
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Six Aerosol Formulations against a Brown Ant
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
150781
Product/Active constituent Name
Application Product Name
TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE
Application Date
Application Number
150781
Application Product Name
TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE
Application details
Product name:
TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE
Product number:
62511
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternate formulation and formulation sites to registraion details
Reference details:
63470 - ACCENSI DIMETHOATE 400 SYSTEMIC INSECTICIDE
Active constituents:
Active constituent name
49020 - DIMETHOATE MANUFACTURING CONCENTRATE
Description of data provided:
Data no
296632
Title
Information from a letter of support from a third party
Study date
November 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
150802
Product/Active constituent Name
Application Product Name
Spirovia 240SC Insecticide
Application Date
Application Number
150802
Application Product Name
Spirovia 240SC Insecticide
Application details
Product name:
Spirovia 240SC Insecticide
Applicant Name:
GROCHEM AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 240 g/L suspension concentrate of spirotetramat for the control of various insect pests in cotton and certain fruit and vegetable crops as per the Directions for Use
Date
Application Date
Application No
Application Number
150804
Product/Active constituent Name
Application Product Name
Agro-Essence Terbutryn 275 + MCPA 160 Herbicide
Application Date
Application Number
150804
Application Product Name
Agro-Essence Terbutryn 275 + MCPA 160 Herbicide
Application details
Product name:
Agro-Essence Terbutryn 275 + MCPA 160 Herbicide
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 275 g/L Terbutryn and 160 g/L MCPA present as the potassium salt suspension concentrate (SC) for the control of seedling broadleaf weeds in wheat, barley, some varieties of oats, pasture and sugar cane.
Date
Application Date
Application No
Application Number
150821
Product/Active constituent Name
Application Product Name
Agro-Essence Diuron 900 WG Herbicide
Application Date
Application Number
150821
Application Product Name
Agro-Essence Diuron 900 WG Herbicide
Application details
Product name:
Agro-Essence Diuron 900 WG Herbicide
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 900 g/kg Diuron water dispersible granule (WG) for the control of weeds in asparagus, bananas, cereals, cotton, lupins, sugar cane.
Date
Application Date
Application No
Application Number
150822
Product/Active constituent Name
Application Product Name
Farmchem Trifluralin 480 Herbicide
Application Date
Application Number
150822
Application Product Name
Farmchem Trifluralin 480 Herbicide
Application details
Product name:
Farmchem Trifluralin 480 Herbicide
Applicant Name:
Nanjing Farmchem Co., Ltd.
Application purpose and description of use:
Registration of a 480 g/L Trifluralin emulsifiable concentrate (EC). A Pre-Emergence Herbicide for the Control of Annual Grasses and Certain Broadleaf Weeds in Certain Horticultural and Agricultural Crops
Date
Application Date
Application No
Application Number
150823
Product/Active constituent Name
Application Product Name
Active Flutriafol 500SC Fungicide
Application Date
Application Number
150823
Application Product Name
Active Flutriafol 500SC Fungicide
Application details
Product name:
Active Flutriafol 500SC Fungicide
Applicant Name:
ACTIVE AGRISCIENCE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 500 g/L FLUTRIAFOL, Suspension Concentrate product for control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser or applied as a foliar spray as per the Directions for Use.
Date
Application Date
Application No
Application Number
150975
Product/Active constituent Name
Application Product Name
Farmwell MCPA 750 Herbicide
Application Date
Application Number
150975
Application Product Name
Farmwell MCPA 750 Herbicide
Application details
Product name:
Farmwell MCPA 750 Herbicide
Applicant Name:
GREENCHEM HK LTD
Application purpose and description of use:
Registration of a 750 g/L MCPA present as the dimethylamine salt Soluble Concentrate (SL) for the Selective Control of Broadleaf Weeds in Cereals, Linseed, Oilseed Poppies, Pastures, Rice, Sugarcane and Turf
Date
Application Date
Application No
Application Number
150977
Product/Active constituent Name
Application Product Name
Farmwell MCPA LVE 570 Herbicide
Application Date
Application Number
150977
Application Product Name
Farmwell MCPA LVE 570 Herbicide
Application details
Product name:
Farmwell MCPA LVE 570 Herbicide
Applicant Name:
GREENCHEM HK LTD
Application purpose and description of use:
Registration of a 570 g/L MCPA present as the 2-ethylhexyl ester Emulsifiable Concentrate (EC) for Selective Control of Certain Weeds in Agricultural Crops
Date
Application Date
Application No
Application Number
150770
Product/Active constituent Name
Application Product Name
SELAMECTIN 60 MG/ML SPOT ON SOLUTION FOR CATS
Application Date
Application Number
150770
Application Product Name
SELAMECTIN 60 MG/ML SPOT ON SOLUTION FOR CATS
Application details
Product name:
SELAMECTIN 60 MG/ML SPOT ON SOLUTION FOR CATS
Product number:
96814
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Registration of a 60 mg/mL selamectin topical spot-on solution for the treatment and control of fleas, heartworm, ear mites, intestinal hookworm and biting lice in cats and the treatment and control of ear mites, sarcoptic mange and cheyletiellosis in rabbits.
Reference details:
50881 - REVOLUTION FOR CATS
Active constituents:
Active constituent name
96815 - selamectin
Description of data provided:
Data no
295348
Title
Product specifications
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
295349
Title
Certificate-2
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
150771
Product/Active constituent Name
Application Product Name
selamectin
Application Date
Application Number
150771
Application Product Name
selamectin
Application details
Product name:
selamectin
Active name:
selamectin
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Approval of new source of pharmacopoeia active.
Description of data provided:
Data no
296093
Title
Certificate-1
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
296092
Title
Certificate of analysis
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
150791
Product/Active constituent Name
Application Product Name
Pymetrozine
Application Date
Application Number
150791
Application Product Name
Pymetrozine
Application details
Product name:
Pymetrozine
Active name:
Pymetrozine
Applicant Name:
SHANGHAI E-TONG CHEMICAL CO LTD
Application purpose and description of use:
Approval of Pymetrozine for use in agricultural chemical products.
Description of data provided:
Data no
296636
Title
Pymetrozine Declaration of Composition (DoC)
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296634
Title
Description Of Manufacturing Process Of Pymetrozine And Impurity Information
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296637
Title
Pymetrozine TGAI Certificates of Analysis and QA Support
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296638
Title
Pymetrozine SAFETY DATA SHEET
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296635
Title
Five Batches Analysis of Pymetrozine TGAI
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296633
Title
Part 2 Pymetrozine Chemistry and Manufacturing
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Date
Application Date
Application No
Application Number
151120
Product/Active constituent Name
Application Product Name
PROTECH BRONCHI-SHIELD ORAL BORDETELLA BRONCHISEPTICA LIVE VACCINE
Application Date
Application Number
151120
Application Product Name
PROTECH BRONCHI-SHIELD ORAL BORDETELLA BRONCHISEPTICA LIVE VACCINE
Application details
Product name:
PROTECH BRONCHI-SHIELD ORAL BORDETELLA BRONCHISEPTICA LIVE VACCINE
Product number:
70050
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the product.
Active constituents:
Active constituent name
83715 - BORDETELLA BRONCHISEPTICA
Description of data provided:
Data no
296098
Title
batch 5245044 part 2
Study date
16/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296104
Title
batch 5245046 - part 2
Study date
24/09/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296107
Title
Antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296101
Title
batch 5245045
Study date
19/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296110
Title
Executive summary Protech Bronchi-Shield Oral
Study date
20/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296102
Title
diluent batch 10J76
Study date
16/04/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296099
Title
batch 5245044 part 3
Study date
16/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296108
Title
PAA 139907 written advice
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296105
Title
batch 5245046 - part 3
Study date
24/09/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296097
Title
batch 5245044
Study date
16/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296106
Title
Stability report
Study date
30/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296100
Title
diluent 10J63S
Study date
08/03/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296109
Title
import permit
Study date
27/08/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296103
Title
batch 5245046
Study date
24/09/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151131
Product/Active constituent Name
Application Product Name
PROTECH MULTI C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Application Date
Application Number
151131
Application Product Name
PROTECH MULTI C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Application details
Product name:
PROTECH MULTI C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Product number:
59730
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the registration.
Active constituents:
Active constituent name
54985 - CANINE DISTEMPER VIRUS
Active constituent name
57265 - HEPATITIS CANINE = CANINE ADENOVIRUS
Active constituent name
57473 - PARVOVIRUS - LIVE
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
54985 - CANINE DISTEMPER VIRUS
Active constituent name
57265 - HEPATITIS CANINE = CANINE ADENOVIRUS
Active constituent name
57473 - PARVOVIRUS - LIVE
Description of data provided:
Data no
296150
Title
Batch 5262012
Study date
20/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296156
Title
import permit
Study date
12/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296153
Title
PAA 139907 written advice
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296154
Title
antigen batch CAV3203THV 012
Study date
12/08/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296157
Title
Executive summary Duramune C3
Study date
20/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296151
Title
Stability report
Study date
28/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296152
Title
antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296155
Title
CDV3166THV specification
Study date
22/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296149
Title
Batch 5262011
Study date
05/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151193
Product/Active constituent Name
Application Product Name
Piperonyl Butoxide
Application Date
Application Number
151193
Application Product Name
Piperonyl Butoxide
Application details
Product name:
Piperonyl Butoxide
Active name:
Piperonyl Butoxide
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Piperonyl Butoxide for use in veterinary chemical products.
Description of data provided:
Data no
296227
Title
DMF 2
Study date
11/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
296225
Title
Certificates of analysis
Study date
14/10/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
296226
Title
DMF 1
Study date
11/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
150403
Product/Active constituent Name
Application Product Name
BAYTRIL 150 FLAVOUR ANTIBACTERIAL TABLETS
Application Date
Application Number
150403
Application Product Name
BAYTRIL 150 FLAVOUR ANTIBACTERIAL TABLETS
Application details
Product name:
BAYTRIL 150 FLAVOUR ANTIBACTERIAL TABLETS
Product number:
58011
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to remove the references to cats and align with the current VLC.
Description of data provided:
Data no
295691
Title
Formulation Details for Baytril 150 Tablets
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
295692
Title
Specification of the Ingredient - Master V24.0
Study date
17 Apr 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
301987
Title
CAS numbers
Study date
24 Feb 2026
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
295693
Title
European Pharmacopoeia 11.0 monograph
Study date
01/2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
150404
Product/Active constituent Name
Application Product Name
BAYTRIL 50 FLAVOUR ANTIBACTERIAL TABLETS
Application Date
Application Number
150404
Application Product Name
BAYTRIL 50 FLAVOUR ANTIBACTERIAL TABLETS
Application details
Product name:
BAYTRIL 50 FLAVOUR ANTIBACTERIAL TABLETS
Product number:
58010
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to align with current Veterinary Labelling Code.
Description of data provided:
Data no
295694
Title
Formulation Details fo Baytril 50 Tablets
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
295695
Title
Specification of the Ingredient - Master V24.0
Study date
17 Apr 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
295696
Title
European Pharmacopoeia 11.0 monograph
Study date
01/2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia