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
154035
Product/Active constituent Name
Application Product Name
Titan CC & Dry OTT Gly 700 Herbicide B
Application Date
Application Number
154035
Application Product Name
Titan CC & Dry OTT Gly 700 Herbicide B
Application details
Product name:
Titan CC & Dry OTT Gly 700 Herbicide B
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of a 700 g/kg Glyphosate present as the mono-ammunium salt product for the control of annual and perennial weeds in Roundup Ready Flex cotton crops, Roundup Ready canola crops, TruFlex canola crops and for the control of annual and perennial weeds in agricultural areas, tree and vine crops, pasture, commercial, industrial and public service areas as per the Directions for Use.
Date
Application Date
Application No
Application Number
153402
Product/Active constituent Name
Application Product Name
Pyrocam 20 mg/mL Solution for Injection
Application Date
Application Number
153402
Application Product Name
Pyrocam 20 mg/mL Solution for Injection
Application details
Product name:
Pyrocam 20 mg/mL Solution for Injection
Product number:
97547
Applicant Name:
Huvepharma EOOD
Application purpose and description of use:
Registration of a 20 mg/ mL meloxicam solution for injection, a non-steroidal anti-inflammatory, analgesic, and
antipyretic injection for use in cattle, sheep, pigs and horses.
Reference details:
54061 - METACAM 20MG/ML SOLUTION FOR INJECTION
Active constituents:
Active constituent name
98280 - Meloxicam
Description of data provided:
Data no
305782
Title
Manufacturing information
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305793
Title
Rel sub validation report
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305762
Title
Pyrocam chemistry and manufacture dossier
Study date
25/05/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305785
Title
Validation report
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305796
Title
Sterility validation report
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305773
Title
Pharmaceutical equivalence - Part 3 of 4
Study date
25/5/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305765
Title
Meloxicam injection monograph
Study date
07/05/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305788
Title
Additional packaging information
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305774
Title
Pharmaceutical equivalence - Part 4 of 4
Study date
25/5/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305768
Title
Batch analysis 2
Study date
jan 2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305791
Title
Methods
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305771
Title
Pharmaceutical equivalence - Part 1 of 4
Study date
25/5/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305794
Title
Excipient validation report
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305786
Title
Excipient certificates of analysis and specifications
Study date
2025
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305792
Title
Assay validation report
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305795
Title
Endotoxin validation report
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305772
Title
Pharmaceutical equivalence - Part 2 of 4
Study date
25/5/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305766
Title
Calculation of endotoxin limit
Study date
01/03/2024
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305783
Title
Calculation of endotoxin limit
Study date
01/03/2024
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305789
Title
Stability study
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305769
Title
Batch analysis 3
Study date
Nov 2025
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305784
Title
Primary packaging
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305790
Title
Stability supporting documents
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305770
Title
Product shelf life - Pyrocam 20
Study date
25/5/2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305764
Title
Certificate of GMP compliance of a manufacturer
Study date
3/11/2025
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305787
Title
Manufacturing Process Validation
Study date
2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Data no
305767
Title
Batch analysis 1
Study date
jan 2026
Auth party contact address
5TH FLOOR, 3 A NIKOLAY HAYTOV STR Sofia Bulgaria
Date
Application Date
Application No
Application Number
153850
Product/Active constituent Name
Application Product Name
ADAMA 2,4-D AMINE 625 HERBICIDE C
Application Date
Application Number
153850
Application Product Name
ADAMA 2,4-D AMINE 625 HERBICIDE C
Application details
Product name:
ADAMA 2,4-D AMINE 625 HERBICIDE C
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 625 g/L 2,4-D Soluble Concentrate (SL) product for use as described in the directions for use.
Date
Application Date
Application No
Application Number
154106
Product/Active constituent Name
Application Product Name
Transocean Optima Antifouling 2.32 Blue
Application Date
Application Number
154106
Application Product Name
Transocean Optima Antifouling 2.32 Blue
Application details
Product name:
Transocean Optima Antifouling 2.32 Blue
Applicant Name:
WAGON PAINTS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 479 g/L cuprous oxide antifouling paint product for the prevention of marine biofouling on vessel hulls
Date
Application Date
Application No
Application Number
154113
Product/Active constituent Name
Application Product Name
SMART TRIFLURALIN 480 EC HERBICIDE (Label B)
Application Date
Application Number
154113
Application Product Name
SMART TRIFLURALIN 480 EC HERBICIDE (Label B)
Application details
Product name:
SMART TRIFLURALIN 480 EC HERBICIDE (Label B)
Applicant Name:
CROP SMART PTY LTD
Application purpose and description of use:
Registration of a 480 g/L Trifluralin emulsifiable concentrate product for control of a pre-emergence herbicide for the control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops as listed in the
Directions for Use table.
Date
Application Date
Application No
Application Number
154133
Product/Active constituent Name
Application Product Name
Tenet 500 SC Herbicide - B
Application Date
Application Number
154133
Application Product Name
Tenet 500 SC Herbicide - B
Application details
Product name:
Tenet 500 SC Herbicide - B
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 500 g/L Metazachlor SC product for use as proposed in the directions for use
Date
Application Date
Application No
Application Number
154142
Product/Active constituent Name
Application Product Name
SpinoSec 240 SC Insecticide
Application Date
Application Number
154142
Application Product Name
SpinoSec 240 SC Insecticide
Application details
Product name:
SpinoSec 240 SC Insecticide
Applicant Name:
ANOVITECH PTY LTD
Application purpose and description of use:
Registration of a 240 g/L suspension concentrate formulation for the control of certain insect pests in fruit,
ornamentals, vegetables and forestry (Eucalyptus spp. and Tea Tree) as specified in the Directions for Use.
Date
Application Date
Application No
Application Number
154263
Product/Active constituent Name
Application Product Name
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Blue
Application Date
Application Number
154263
Application Product Name
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Blue
Application details
Product name:
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Blue
Applicant Name:
AKZO NOBEL PTY LIMITED
Application purpose and description of use:
Registration of Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Blue
Active Constituents:
1031g/L Cuprous Oxide
Solvent: 407g/L Liquid Hydrocarbon
Use as an antifouling paint to control marine growth below the waterline on vessels.
Date
Application Date
Application No
Application Number
154266
Product/Active constituent Name
Application Product Name
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Black
Application Date
Application Number
154266
Application Product Name
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Black
Application details
Product name:
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Black
Applicant Name:
AKZO NOBEL PTY LIMITED
Application purpose and description of use:
Registration of Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Black
Active Constituents:
1042g/L Cuprous Oxide
Solvent: 404g/L Liquid Hydrocarbon
Use as an antifouling paint to control marine growth below the waterline on vessels.
Date
Application Date
Application No
Application Number
154267
Product/Active constituent Name
Application Product Name
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Red
Application Date
Application Number
154267
Application Product Name
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Red
Application details
Product name:
Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Red
Applicant Name:
AKZO NOBEL PTY LIMITED
Application purpose and description of use:
Registration of Sea Hawk Premium Yacht Finishes Premium Quality Cukote Eroding Antifouling Coating Red
Active Constituents:
1089g/L Cuprous Oxide
Solvent: 385g/L Liquid Hydrocarbon
Use as an antifouling paint to control marine growth below the waterline on vessels.
Date
Application Date
Application No
Application Number
153448
Product/Active constituent Name
Application Product Name
Swan Acidifier Pro 700 Spray Adjuvant
Application Date
Application Number
153448
Application Product Name
Swan Acidifier Pro 700 Spray Adjuvant
Application details
Product name:
Swan Acidifier Pro 700 Spray Adjuvant
Applicant Name:
SWAN CHEMICAL HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a (350 g/L SOYAL PHOSPHOLIPIDS & 350 g/L PROPIONIC ACID dispersible concentrate product for Acidifying and Penetrating Surfactant; Reduces Alkaline Hydrolysis of Dimethoate; Assists with Uptake of Foliar Fertilisers; Assists in Management of Spray Droplet Size
Date
Application Date
Application No
Application Number
152220
Product/Active constituent Name
Application Product Name
Gabapentin
Application Date
Application Number
152220
Application Product Name
Gabapentin
Application details
Product name:
Gabapentin
Product number:
97191
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a gabapentin tablet product for anxiety and analgesia in cats, in conjunction with approval of the active constituent gabapentin.
Description of data provided:
Data no
302238
Title
Gabapentin DMF Part 4
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302235
Title
Gabapentin DMF Part 1
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302236
Title
Gabapentin DMF Part 2
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302239
Title
Gabapentin DMF Part 5
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302234
Title
CoA Gabapentin
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
302237
Title
Gabapentin DMF Part 3
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Date
Application Date
Application No
Application Number
152222
Product/Active constituent Name
Application Product Name
Gabacalm 50 mg
Application Date
Application Number
152222
Application Product Name
Gabacalm 50 mg
Application details
Product name:
Gabacalm 50 mg
Product number:
97193
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a gabapentin tablet product for anxiety and analgesia in cats, in conjunction with approval of the active constituent gabapentin.
Date
Application Date
Application No
Application Number
154426
Product/Active constituent Name
Application Product Name
TRIBRISSEN 20 TABLETS
Application Date
Application Number
154426
Application Product Name
TRIBRISSEN 20 TABLETS
Application details
Product name:
TRIBRISSEN 20 TABLETS
Product number:
36122
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product label approval to update the product RLP.
Description of data provided:
Data no
307514
Title
Cover Letter for application
Study date
July 2026
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
153447
Product/Active constituent Name
Application Product Name
Swan Glyphosate 540 K Herbicide
Application Date
Application Number
153447
Application Product Name
Swan Glyphosate 540 K Herbicide
Application details
Product name:
Swan Glyphosate 540 K Herbicide
Applicant Name:
SWAN CHEMICAL HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 540 g/L GLYPHOSATE present as the potassium salt soluble concentrate product for Non-selective Herbicide for the Control of Many Annual and Perennial Weeds.
Date
Application Date
Application No
Application Number
153824
Product/Active constituent Name
Application Product Name
SpinoSec 240 SC Insecticide B
Application Date
Application Number
153824
Application Product Name
SpinoSec 240 SC Insecticide B
Application details
Product name:
SpinoSec 240 SC Insecticide B
Applicant Name:
ANOVITECH PTY LTD
Application purpose and description of use:
Registration of a 240 g/L suspension concentrate formulation for the control of certain insect pests in fruit,
ornamentals, vegetables and forestry (Eucalyptus spp. and Tea Tree) as specified in the Directions for Use.
Date
Application Date
Application No
Application Number
154018
Product/Active constituent Name
Application Product Name
Hempaguard X7 89900 Fouling Defence Coating 89909 59161 Red
Application Date
Application Number
154018
Application Product Name
Hempaguard X7 89900 Fouling Defence Coating 89909 59161 Red
Application details
Product name:
Hempaguard X7 89900 Fouling Defence Coating 89909 59161 Red
Applicant Name:
HEMPEL (WATTYL) AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 77 g/L Copper Pyrithione antifouling paint for the prevention of marine biofouling on vessel hulls
Date
Application Date
Application No
Application Number
154019
Product/Active constituent Name
Application Product Name
Hempaguard X7 89900 Fouling Defence Coating 89909 19740 Black
Application Date
Application Number
154019
Application Product Name
Hempaguard X7 89900 Fouling Defence Coating 89909 19740 Black
Application details
Product name:
Hempaguard X7 89900 Fouling Defence Coating 89909 19740 Black
Applicant Name:
HEMPEL (WATTYL) AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 87 g/L copper pyrithione antifouling paint for prevention of marine biofouling on vessel hulls.
Date
Application Date
Application No
Application Number
154036
Product/Active constituent Name
Application Product Name
SPRAY.SEED 250 Herbicide
Application Date
Application Number
154036
Application Product Name
SPRAY.SEED 250 Herbicide
Application details
Product name:
SPRAY.SEED 250 Herbicide
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 135 g/L paraquat present as paraquat dichloride and 115 g/L diquat present as diquat dibromide soluble concentrate product for the control of a wide range of grasses and broadleaf weeds.
Date
Application Date
Application No
Application Number
154046
Product/Active constituent Name
Application Product Name
Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red
Application Date
Application Number
154046
Application Product Name
Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red
Application details
Product name:
Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red
Applicant Name:
AKZO NOBEL PTY LIMITED
Application purpose and description of use:
Registration of Intercept 8500 Tin Free Linear Polishing Polymer Antifouling Red
Active Constituents:
830 g/L COPPER PRESENT AS CUPROUS OXIDE
64 g/L COPPER PYRITHIONE
Use as an antifouling paint to control marine growth below the waterline on vessels.