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
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
151146
Product/Active constituent Name
Application Product Name
SERESTO FOR KITTENS AND CATS FLEAS AND TICK COLLAR
Application Date
Application Number
151146
Application Product Name
SERESTO FOR KITTENS AND CATS FLEAS AND TICK COLLAR
Application details
Product name:
SERESTO FOR KITTENS AND CATS FLEAS AND TICK COLLAR
Product number:
80642
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation to product label.
Active constituents:
Active constituent name
49016 - IMIDACLOPRID
Active constituent name
62446 - FLUMETHRIN
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.
Description of data provided:
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
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
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
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
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
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
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
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
296107
Title
Antigen stability
Study date
01/06/2023
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
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
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
296100
Title
diluent 10J63S
Study date
08/03/2024
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
296102
Title
diluent batch 10J76
Study date
16/04/2024
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
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
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
296109
Title
import permit
Study date
27/08/2025
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
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
296108
Title
PAA 139907 written advice
Study date
04/07/2023
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
DURAMUNE ADULT C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Application Date
Application Number
151131
Application Product Name
DURAMUNE ADULT C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Application details
Product name:
DURAMUNE ADULT 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
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
296155
Title
CDV3166THV specification
Study date
22/09/2023
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
296149
Title
Batch 5262011
Study date
05/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
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
296151
Title
Stability report
Study date
28/02/2025
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
296153
Title
PAA 139907 written advice
Study date
04/07/2023
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
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
Data no
296227
Title
DMF 2
Study date
11/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
150449
Product/Active constituent Name
Application Product Name
Advocate Advance Chewable Tablets for Very Large Dogs
Application Date
Application Number
150449
Application Product Name
Advocate Advance Chewable Tablets for Very Large Dogs
Application details
Product name:
Advocate Advance Chewable Tablets for Very Large Dogs
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a (33.75 mg/Tb Milbemycin oxime & 900.0 mg/Tb Lotilaner) chewable tablets as oral parasiticides for very large dogs.
Date
Application Date
Application No
Application Number
150451
Product/Active constituent Name
Application Product Name
Advocate Advance Chewable Tablets for Large Dogs
Application Date
Application Number
150451
Application Product Name
Advocate Advance Chewable Tablets for Large Dogs
Application details
Product name:
Advocate Advance Chewable Tablets for Large Dogs
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a (16.88 mg/Tb Milbemycin oxime & 450.0 mg/Tb Lotilaner) chewable tablets as oral parasiticides for large dogs.
Date
Application Date
Application No
Application Number
150452
Product/Active constituent Name
Application Product Name
Advocate Advance Chewable Tablets for Medium Dogs
Application Date
Application Number
150452
Application Product Name
Advocate Advance Chewable Tablets for Medium Dogs
Application details
Product name:
Advocate Advance Chewable Tablets for Medium Dogs
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a (8.44 mg/Tb Milbemycin oxime & 225.0 mg/Tb Lotilaner) chewable tablets as oral parasiticides for medium dogs.
Date
Application Date
Application No
Application Number
150453
Product/Active constituent Name
Application Product Name
Advocate Advance Chewable Tablets for Small Dogs
Application Date
Application Number
150453
Application Product Name
Advocate Advance Chewable Tablets for Small Dogs
Application details
Product name:
Advocate Advance Chewable Tablets for Small Dogs
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a (4.22 mg/Tb Milbemycin oxime & 112.5 mg/Tb Lotilaner) chewable tablets as oral parasiticides for
small dogs.
Date
Application Date
Application No
Application Number
150454
Product/Active constituent Name
Application Product Name
Advocate Advance Chewable Tablets for Very Small Dogs
Application Date
Application Number
150454
Application Product Name
Advocate Advance Chewable Tablets for Very Small Dogs
Application details
Product name:
Advocate Advance Chewable Tablets for Very Small Dogs
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a (2.11 mg/Tb Milbemycin oxime & 56.25 mg/Tb Lotilaner) chewable tablets as oral parasiticides for very small dogs.
Date
Application Date
Application No
Application Number
150474
Product/Active constituent Name
Application Product Name
Tulathromycin
Application Date
Application Number
150474
Application Product Name
Tulathromycin
Application details
Product name:
Tulathromycin
Active name:
Tulathromycin
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of a new source of active for use in veterinary chemical products.
Description of data provided:
Data no
296614
Title
Analytical Procedures
Study date
Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296615
Title
General Test Method
Study date
5 Aug 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296616
Title
General Test Method
Study date
5 Aug 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296617
Title
Validation report of water content in Tulathromycin by
coulometric Karl Fischer
coulometric Karl Fischer
Study date
16 May 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296618
Title
Validation of Analytical Procedures
Study date
Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296619
Title
Final Report for the Method Validation
Study date
6 March 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296620
Title
Compendial Verification Report
Study date
14 Nov 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296621
Title
Compendial Verification Report
Study date
08 Jan 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296622
Title
Compendial Test Methods for Specific Rotation analysis
Study date
18 Dec 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296623
Title
Compendial Test Method for Residue on Ignition analysis
Study date
15 Nov 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296624
Title
Comparative Transfer Protocol for the Rathdrum Site Assay and Impurities Test Method
Study date
06 Aug 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
293111
Title
Certificate of analysis
Study date
12 June 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
293112
Title
Specification
Study date
9 May 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296626
Title
Regulatory Process Description
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296627
Title
Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296625
Title
Declaration
Study date
11 Jun 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES 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
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
Date
Application Date
Application No
Application Number
149646
Product/Active constituent Name
Application Product Name
QA Imidacloprid 350 SC Insecticide
Application Date
Application Number
149646
Application Product Name
QA Imidacloprid 350 SC Insecticide
Application details
Product name:
QA Imidacloprid 350 SC Insecticide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 350 g/L Imidacloprid suspension concentrate (SC) product for the control of various soil pests in
sugarcane and peanuts, certain pests in apples, citrus and various vegetable crops by soil treatment, and for the
control of certain pests in bananas by pseudostem injection as specified in the DIRECTIONS FOR USE table Â
Date
Application Date
Application No
Application Number
151019
Product/Active constituent Name
Application Product Name
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
Application Date
Application Number
151019
Application Product Name
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
Application details
Product name:
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
Product number:
36026
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation to product registration to amend the formulation table and update the approved label.
Active constituents:
Active constituent name
85269 - SODIUM CHLORIDE
Active constituent name
84698 - CALCIUM GLUCONATE
Active constituent name
85195 - NEOMYCIN SULPHATE
Active constituent name
85149 - HYOSCINE HYDROBROMIDE
Active constituent name
85177 - MAGNESIUM SULPHATE HEPTAHYDRATE
Active constituent name
85265 - STREPTOMYCIN SULPHATE
Active constituent name
85336 - SULPHADIMIDINE
Active constituent name
85337 - SULPHADIAZINE
Active constituent name
85556 - GLYCINE
Active constituent name
85601 - POTASSIUM CHLORIDE