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
151882
Product/Active constituent Name
Application Product Name
OrganixKill Cockroach Killer Gel Bait
Application Date
Application Number
151882
Application Product Name
OrganixKill Cockroach Killer Gel Bait
Application details
Product name:
OrganixKill Cockroach Killer Gel Bait
Product number:
97107
Applicant Name:
ORGANIX SOLUTIONZ PTY LTD
Application purpose and description of use:
Registration of a 200g/kg boric acid cockroach direct gel for the control of Blatella germanica ( german cockroaches) and Periplaneta americana ( American cockroach) infestations in domestic and commercial situations.
Description of data provided:
Data no
301694
Title
OrganixKill Cockroach Killer Gel Bait Method of Manufacture
Study date
20/01/2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301695
Title
Boric Acid Certificate of Analysis
Study date
2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301696
Title
Specification Boric Acid
Study date
2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301697
Title
OrganixKill Cockroach Killer Gel Batch Analysis
Study date
5/05/2025
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301698
Title
Stability Report OrganixKill
Study date
5/05/2025
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301699
Title
An arena study to determine the efficacy of an Organix Solutionz Cockroach Gel against the German and American cockroach
Study date
28/04/2025
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301700
Title
Efficacy Test Protocol Rationale
Study date
2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301701
Title
PSDS OrganixKill Cockroach Gel
Study date
2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301702
Title
Boric acid assay
Study date
2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Data no
301703
Title
Boric Acid PSDS
Study date
2026
Auth party contact address
50 Cantrell St YAGOONA Australia
Date
Application Date
Application No
Application Number
151933
Product/Active constituent Name
Application Product Name
Titan CC & Dry OTT Gly 700 Herbicide
Application Date
Application Number
151933
Application Product Name
Titan CC & Dry OTT Gly 700 Herbicide
Application details
Product name:
Titan CC & Dry OTT Gly 700 Herbicide
Product number:
63021
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of label approval to add control of annual and perennial weeds in XtendFlex cotton.
Active constituents:
Active constituent name
56663 - GLYPHOSATE
Description of data provided:
Data no
301805
Title
Titan CC & Dry OTT Gly 700 Herbicide Residues module 5.4
Study date
6.2.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301806
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
16.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301807
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
13.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301808
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
7.1.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301809
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
13.12.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301810
Title
Titan CC & Dry OTT Gly 700 Herbicide draft label
Study date
6.2.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301811
Title
Titan Cc & Dry OTT Gly 700 Herbicide Efficacy and Crop Safety Module 8.2
Study date
6.2.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301812
Title
Bioequivalence of Titan CC & Dry OTT Gly Herbicide with Roundup Ready with Plantshield for Weed Control and Crop Safety in XtendFlex Cotton.
Study date
29.9.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301813
Title
Bioequivalence of Titan CC & Dry OTT Gly Herbicide with Roundup Ready Herbicide with Plantshield for Crop Safety in XtendFlex Cotton.
Study date
13.10.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301814
Title
Trial ??? Titan CC & Dry OTT Gly 700 Bioequivalence in XtendFlex Cotton
Study date
April 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301815
Title
Titan CC & Dry OTT Gly 700 Herbicide draft label
Study date
6.2.2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
301816
Title
Pre-Application Assistance - APVMA Written Advice 63021_141185
Study date
2.9.2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
152187
Product/Active constituent Name
Application Product Name
Meloxi-Care Oral Suspension
Application Date
Application Number
152187
Application Product Name
Meloxi-Care Oral Suspension
Application details
Product name:
Meloxi-Care Oral Suspension
Product number:
91496
Applicant Name:
Alberta Veterinary Laboratories Ltd
Application purpose and description of use:
Variation of product registration to amend relevant particulars.
Active constituents:
Active constituent name
87801 - MELOXICAM
Description of data provided:
Data no
301510
Title
Certificates of analysis
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301511
Title
Monograph
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301512
Title
Report 1
Study date
2019
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301513
Title
Report 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301514
Title
Report 3
Study date
2021
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301515
Title
Report 4
Study date
2026
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301516
Title
Product specifications
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301517
Title
Report 5
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301518
Title
Report 6
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301519
Title
Method
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301520
Title
Article 1
Study date
2019
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301521
Title
Article 2
Study date
2014
Auth party contact address
7226 107 Ave Calgary Canada
Data no
301522
Title
Article 3
Study date
1988
Auth party contact address
7226 107 Ave Calgary Canada
Date
Application Date
Application No
Application Number
151934
Product/Active constituent Name
Application Product Name
AquaHealth Ultramax Algaecide
Application Date
Application Number
151934
Application Product Name
AquaHealth Ultramax Algaecide
Application details
Product name:
AquaHealth Ultramax Algaecide
Product number:
97119
Applicant Name:
EARTH SCIENCE LABORATORIES INTERNATIONAL PTY LTD
Application purpose and description of use:
Registration of a 60 g/L Copper present as Copper Sulfate Pentahydrate soluble concentrate (SL) product to control Algae, Slime, Blackspot and Unwanted Wall Growth in Swimming Pools, Summer and Winter
Reference details:
89179 - AlgaeShield Algaecide
Date
Application Date
Application No
Application Number
151930
Product/Active constituent Name
Application Product Name
Gonadotropin Serum
Application Date
Application Number
151930
Application Product Name
Gonadotropin Serum
Application details
Product name:
Gonadotropin Serum
Active name:
Gonadotropin Serum
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Approval of a manufacturer of the active constituent for use in veterinary chemical products
Description of data provided:
Data no
301327
Title
3 x CoAs of active
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
301328
Title
EP compendial standard for active
Study date
2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
301329
Title
MSD specification version 3 for active
Study date
26 Jun 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
301330
Title
Batch analysis
Study date
November 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151866
Product/Active constituent Name
Application Product Name
DEFINE 250 EC Fungicide
Application Date
Application Number
151866
Application Product Name
DEFINE 250 EC Fungicide
Application details
Product name:
DEFINE 250 EC Fungicide
Product number:
96031
Applicant Name:
CENTRIS SOLUTIONS PTY LTD
Application purpose and description of use:
Variation of product registration to include additional crops and diseases.
Reference details:
65130 - NUFARM DIGGER FUNGICIDE
90198 - Nufarm Digger EW Fungicide
Active constituents:
Active constituent name
58172 - DIFENOCONAZOLE
Description of data provided:
Data no
301491
Title
Part 8 DEFINE Item 14
Study date
3 February 2026
Auth party contact address
3/22–24 Strathwyn Street Brendale Australia
Data no
301492
Title
Bioequivalence of DEFINE and Digger EW in grapes
Study date
2 February 2026
Auth party contact address
3/22–24 Strathwyn Street Brendale Australia
Data no
301493
Title
Nufarm Digger EW Fungicide Label
Study date
14 December 2022
Auth party contact address
3/22–24 Strathwyn Street Brendale Australia
Data no
301494
Title
Other references
Study date
2026
Auth party contact address
3/22–24 Strathwyn Street Brendale Australia
Date
Application Date
Application No
Application Number
151673
Product/Active constituent Name
Application Product Name
That's It. Insect Repel
Application Date
Application Number
151673
Application Product Name
That's It. Insect Repel
Application details
Product name:
That's It. Insect Repel
Product number:
97062
Applicant Name:
M100 Ltd
Application purpose and description of use:
Registration of a topical insect repellent balm containing citrepel 75 at 200 g/kg for use as a personal insect repellent in humans.
Date
Application Date
Application No
Application Number
151597
Product/Active constituent Name
Application Product Name
Vets’ Own Carprofen 75 mg Chewable Tablets for Dogs
Application Date
Application Number
151597
Application Product Name
Vets’ Own Carprofen 75 mg Chewable Tablets for Dogs
Application details
Product name:
Vets’ Own Carprofen 75 mg Chewable Tablets for Dogs
Product number:
97029
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of 75 mg carprofen tablets for the relief of pain and inflammation in dogs.
Reference details:
52468 - RIMADYL 25MG CHEWABLE TABLETS FOR DOGS
51746 - RIMADYL 50MG TABLETS FOR DOGS
51747 - RIMADYL 20MG TABLETS FOR DOGS
52469 - RIMADYL 75MG CHEWABLE TABLETS FOR DOGS
52470 - RIMADYL 100MG CHEWABLE TABLETS FOR DOGS
Date
Application Date
Application No
Application Number
151598
Product/Active constituent Name
Application Product Name
Vets’ Own Carprofen 100 mg Chewable Tablets for Dogs
Application Date
Application Number
151598
Application Product Name
Vets’ Own Carprofen 100 mg Chewable Tablets for Dogs
Application details
Product name:
Vets’ Own Carprofen 100 mg Chewable Tablets for Dogs
Product number:
97030
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of 100 mg carprofen tablets for the relief of pain and inflammation in dogs.
Reference details:
52468 - RIMADYL 25MG CHEWABLE TABLETS FOR DOGS
51746 - RIMADYL 50MG TABLETS FOR DOGS
51747 - RIMADYL 20MG TABLETS FOR DOGS
52469 - RIMADYL 75MG CHEWABLE TABLETS FOR DOGS
52470 - RIMADYL 100MG CHEWABLE TABLETS FOR DOGS
Date
Application Date
Application No
Application Number
151599
Product/Active constituent Name
Application Product Name
Carprofen
Application Date
Application Number
151599
Application Product Name
Carprofen
Application details
Product name:
Carprofen
Active name:
Carprofen
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
300596
Title
Carprofen certificates of analysis
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Date
Application Date
Application No
Application Number
151425
Product/Active constituent Name
Application Product Name
Family Protection Aerogard Body Insect Repellent Lotion
Application Date
Application Number
151425
Application Product Name
Family Protection Aerogard Body Insect Repellent Lotion
Application details
Product name:
Family Protection Aerogard Body Insect Repellent Lotion
Product number:
96984
Applicant Name:
VEH AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 100 g/L picaridin lotion product for use as a personal insect repellent.
Reference details:
61365 - DEVELOPED AND TESTED IN AUSTRALIA FAMILY PROTECTION AEROGARD BODY ODOURLESS PROTECTION 6 HOURS PROTECTION LOW IRRITANT ON SKIN FRAGRANCE FREE INSECT REPELLENT SPRAY
62611 - OFF! FAMILYCARE INSECT REPELLENT FREE
50759 - AUTAN REPEL INSECT REPELLENT TROPICAL STRENGTH LOTION
Active constituents:
Active constituent name
44493 - PICARIDIN
Active constituent name
86247 - Picaridin
Description of data provided:
Data no
300319
Title
Confirmation of Overseas Product Registration
Study date
17.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300320
Title
Registration Stability Report - Accelarated (2 weeks)
Study date
03.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300321
Title
Supporting Chemistry & Manufacturing Documents
Study date
15.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300322
Title
Quantification of Picaridin in Water in Oil Emulsion Formulation
Study date
27.11.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300323
Title
Health Module documents
Study date
16.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300324
Title
Efficacy Substantiation Report
Study date
02.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300325
Title
Laboratory Study to Determine the Complete Protection Time (CPT) of Three Personal Insect Repellents Against Aedes aegypti
Study date
25.03.2020
Auth party contact address
680 George Street Sydney Australia
Data no
300326
Title
Laboratory Study to Determine the Complete Protection Time (CPT) of Three Personal Insect Repellents Against Culex quinquefasciatus
Study date
25.03.2020
Auth party contact address
680 George Street Sydney Australia
Data no
300327
Title
Claim Support - Odourless
Study date
08.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300328
Title
Claim Support - Dermatological testing
Study date
02.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300329
Title
ASSESSMENT OF SKIN MOISTURIZATION (CORNEOMETRY) AFTER APPLICATION OF A TOPICAL PRODUCT
Study date
21/10/2025
Auth party contact address
680 George Street Sydney Australia
Data no
300330
Title
ASSESSMENT OF THE SKIN ACCEPTANCE OF A REPELLENT (079679-02) UNDER NORMAL USE CONDITIONS, IN SUBJECTS WITH SENSITIVE SKIN
Study date
04/12/2025
Auth party contact address
680 George Street Sydney Australia
Data no
300331
Title
ASSESSMENT OF THE SKIN PHOTOALLERGY AND PHOTOTOXICITY POTENTIAL OF A REPELLENT (E008601E-02), UNDER CONTROLLED AND MAXIMIZED CONDITIONS (FA-FT)
Study date
04/12/2025
Auth party contact address
680 George Street Sydney Australia
Data no
300332
Title
ASSESSMENT OF THE PRIMARY AND CUMULATIVE SKIN IRRITATION POTENTIAL, AND SKIN SENSITIZATION POTENTIAL OF A REPELLENT (079679-02), UNDER CONTROLLED AND MAXIMIZED CONDITIONS
Study date
04/12/2025
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
151426
Product/Active constituent Name
Application Product Name
Family Protection Aerogard Body Insect Repellent Roll-on
Application Date
Application Number
151426
Application Product Name
Family Protection Aerogard Body Insect Repellent Roll-on
Application details
Product name:
Family Protection Aerogard Body Insect Repellent Roll-on
Product number:
96985
Applicant Name:
VEH AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 100 g/L picaridin roll-on product for use as a personal insect repellent.
Reference details:
61363 - DEVELOPED AND TESTED IN AUSTRALIA FAMILY PROTECTION AEROGARD BODY ODOURLESS PROTECTION 6 HOURS PROTECTION LOW IRRITANT ON SKIN FRAGRANCE FREE INSECT REPELLENT ROLL-ON
50758 - AUTAN REPEL INSECT REPELLENT TROPICAL STRENGTH ROLL ON
62611 - OFF! FAMILYCARE INSECT REPELLENT FREE
Active constituents:
Active constituent name
44493 - PICARIDIN
Active constituent name
86247 - Picaridin
Description of data provided:
Data no
300505
Title
Confirmation of Overseas Product Registration
Study date
17.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300506
Title
Registration Stability Report - Accelarated (2 weeks)
Study date
08.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300507
Title
Supporting Chemistry & Manufacturing Documents
Study date
15.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300508
Title
Quantification of Picaridin in Water in Oil Emulsion Formulation
Study date
27.11.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300509
Title
Health Module documents
Study date
16.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300510
Title
Efficacy Substantiation Report
Study date
02.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300511
Title
Laboratory Study to Determine the Complete Protection Time (CPT) of Three Personal Insect Repellents Against Aedes aegypti
Study date
25.03.2020
Auth party contact address
680 George Street Sydney Australia
Data no
300512
Title
Laboratory Study to Determine the Complete Protection Time (CPT) of Three Personal Insect Repellents Against Culex quinquefasciatus
Study date
25.03.2020
Auth party contact address
680 George Street Sydney Australia
Data no
300513
Title
Odourless Claim Support
Study date
08.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300514
Title
Claim Support - Dermatological testing
Study date
02.12.2025
Auth party contact address
680 George Street Sydney Australia
Data no
300515
Title
ASSESSMENT OF SKIN MOISTURIZATION (CORNEOMETRY) AFTER APPLICATION OF A TOPICAL PRODUCT
Study date
21/10/2025
Auth party contact address
680 George Street Sydney Australia
Data no
300516
Title
ASSESSMENT OF THE SKIN ACCEPTANCE OF A REPELLENT (079679-02) UNDER NORMAL USE CONDITIONS, IN SUBJECTS WITH SENSITIVE SKIN
Study date
04/12/2025
Auth party contact address
680 George Street Sydney Australia
Data no
300517
Title
ASSESSMENT OF THE SKIN PHOTOALLERGY AND PHOTOTOXICITY POTENTIAL OF A REPELLENT (E008601E-02), UNDER CONTROLLED AND MAXIMIZED CONDITIONS (FAFT)
Study date
04/12/2025
Auth party contact address
680 George Street Sydney Australia
Data no
300518
Title
ASSESSMENT OF THE PRIMARY AND CUMULATIVE SKIN IRRITATION POTENTIAL, AND SKIN SENSITIZATION POTENTIAL OF A REPELLENT (079679-02), UNDER CONTROLLED AND MAXIMIZED CONDITIONS
Study date
04/12/2025
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
151596
Product/Active constituent Name
Application Product Name
Vets’ Own Carprofen 25 mg Chewable Tablets for Dogs
Application Date
Application Number
151596
Application Product Name
Vets’ Own Carprofen 25 mg Chewable Tablets for Dogs
Application details
Product name:
Vets’ Own Carprofen 25 mg Chewable Tablets for Dogs
Product number:
97028
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of 25 mg carprofen tablets for the relief of pain and inflammation in dogs.
Reference details:
52468 - RIMADYL 25MG CHEWABLE TABLETS FOR DOGS
51746 - RIMADYL 50MG TABLETS FOR DOGS
51747 - RIMADYL 20MG TABLETS FOR DOGS
52469 - RIMADYL 75MG CHEWABLE TABLETS FOR DOGS
52470 - RIMADYL 100MG CHEWABLE TABLETS FOR DOGS
Active constituents:
Active constituent name
97031 - Carprofen
Description of data provided:
Data no
300146
Title
Certificate-1
Study date
2024
Auth party contact address
-
Data no
300147
Title
Certificate-2
Study date
2023
Auth party contact address
-
Data no
300148
Title
Part 2 Chemistry and Manufacture
Study date
2026
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300149
Title
Dossier
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300150
Title
Specifications study 1
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300151
Title
Specifications study 2
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300152
Title
Specifications study 3
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300153
Title
Verification report 1
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300154
Title
Validation report 1
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300155
Title
Verification report 2
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300156
Title
Validation report 2
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300157
Title
Validation report 3
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300158
Title
Validation report 4
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300159
Title
Suitability report
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300160
Title
Development report
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300161
Title
Validation report 5
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300162
Title
Stability report 1
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300163
Title
Stability report 2
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300164
Title
Stability report 3
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300165
Title
Stability report 4
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300167
Title
Excipients certificates of analysis
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300168
Title
Excipient 1
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300169
Title
Excipient 2
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300170
Title
Excipient 3
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300171
Title
Packaging
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300172
Title
Product specifications
Study date
2026
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300173
Title
Part 8 Efficacy and Safety
Study date
2026
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300174
Title
Study report 1
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300175
Title
Study report 2
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300176
Title
Study report 3
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300177
Title
Validation report 1
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300178
Title
Validation report 2
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300179
Title
Validation report 3
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300180
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Auth party contact address
-
Data no
300181
Title
Excipient information
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300182
Title
Excipient information
Study date
2024
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
300183
Title
Study report 4
Study date
2025
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Data no
301428
Title
Application
Study date
2026
Auth party contact address
459 Church Street Giffnock Ave Macquarie Park Australia
Date
Application Date
Application No
Application Number
151266
Product/Active constituent Name
Application Product Name
Izenivetmab
Application Date
Application Number
151266
Application Product Name
Izenivetmab
Application details
Product name:
Izenivetmab
Product number:
96925
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151268
Product/Active constituent Name
Application Product Name
Lenivia 1 mg Solution for Injection for Dogs
Application Date
Application Number
151268
Application Product Name
Lenivia 1 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 1 mg Solution for Injection for Dogs
Product number:
96927
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 1 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151269
Product/Active constituent Name
Application Product Name
Lenivia 1.5 mg Solution for Injection for Dogs
Application Date
Application Number
151269
Application Product Name
Lenivia 1.5 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 1.5 mg Solution for Injection for Dogs
Product number:
96928
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 1.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151270
Product/Active constituent Name
Application Product Name
Lenivia 2 mg Solution for Injection for Dogs
Application Date
Application Number
151270
Application Product Name
Lenivia 2 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 2 mg Solution for Injection for Dogs
Product number:
96929
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 2 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151271
Product/Active constituent Name
Application Product Name
Lenivia 3 mg Solution for Injection for Dogs
Application Date
Application Number
151271
Application Product Name
Lenivia 3 mg Solution for Injection for Dogs
Application details
Product name:
Lenivia 3 mg Solution for Injection for Dogs
Product number:
96930
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 3 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application Date
Application No
Application Number
151706
Product/Active constituent Name
Application Product Name
RIFAWAY Fire Ant Bait HG
Application Date
Application Number
151706
Application Product Name
RIFAWAY Fire Ant Bait HG
Application details
Product name:
RIFAWAY Fire Ant Bait HG
Product number:
97077
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 g/kg indoxacarb (Ready-to-use-bait) product for the control of Fire Ants around buildings,
gardens, grazing areas, lawns and public areas.
Reference details:
66532 - ADVION FIRE ANT BAIT
94840 - Rifaway Fire Ant Bait
Active constituents:
Active constituent name
66198 - INDOXACARB
Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE
Description of data provided:
Data no
301022
Title
Technical Argument ??? Control of red imported fire ant - Home Garden use
Study date
23 Jan 2026
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
301023
Title
Advion Fire Ant Bait Permit
Study date
15 Mar 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151265
Product/Active constituent Name
Application Product Name
Izenivetmab
Application Date
Application Number
151265
Application Product Name
Izenivetmab
Application details
Product name:
Izenivetmab
Product number:
96924
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Description of data provided:
Data no
298655
Title
module 3.2.S.1 - General Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298656
Title
module 3.2.S.2.1 - Manufacturer
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298657
Title
module 3.2.S.2.2 - Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298658
Title
module 3.2.S.2.2 - Annex 1 - Regulatory Method of Manufacturing Active Substance - Izenivetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298659
Title
module 3.2.S.2.2 - Annex 2 - Active Substance Manufacturing Flow Chart - Izenivetmab FDS
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298660
Title
module 3.2.S.2.3.1 - Control of Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298661
Title
module 3.2.S.2.3.1 - Annex 1 - Upstream Raw Material Certificates of Analysis and TSE Declarations
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298662
Title
module 3.2.S.2.3.1 - Annex 2 - Downstream Raw Material Certificates of Analysis and TSE Declarations
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298663
Title
module 3.2.S.2.3.1 - Annex 3 - Chromatography Resin Certificates of Analysis
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298664
Title
module 3.2.S.2.3.1 - Annex 4 - Cell Boost 7a Technical Package
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298665
Title
module 3.2.S.2.3.1 - Annex 5 - Cell Boost 7b Technical Package
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298666
Title
module 3.2.S.2.3.2 - Starting Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298667
Title
module 3.2.S.2.3.2 - Annex 1 - MCB Report
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298668
Title
module 3.2.S.2.3.2 - Annex 2 - Protocol for Generation of WCB
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298669
Title
module 3.2.S.2.3.2 - Annex 3 - Genetic Stability Assessment
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298670
Title
module 3.2.S.2.4 - Control of Critical Steps
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298671
Title
module 3.2.S.2.5 - Process Validation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298672
Title
module 3.2.S.2.5 - Annex 1 - Report - Viral Clearance Validation
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298673
Title
module 3.2.S.2.6 - Manufacturing Process Development
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298674
Title
module 3.2.S.3 - Characterisation
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298675
Title
module 3.2.S.4.1 - Specification Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298676
Title
module 3.2.S.4.2 - Analytical Procedures Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298677
Title
module 3.2.S.4.2 - Annex 1 - Method 1061.057
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298678
Title
module 3.2.S.4.2 - Annex 2 - Method 1061.054
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298679
Title
module 3.2.S.4.2 - Annex 3 - Method 1061.056
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298680
Title
module 3.2.S.4.2 - Annex 4 - Method 1061.055
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298681
Title
module 3.2.S.4.2 - Annex 5 - Method 1061.004
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298682
Title
module 3.2.S.4.2 - Annex 6 - Method 1061.005
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298683
Title
module 3.2.S.4.2 - Annex 7 - Method GM099
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298684
Title
module 3.2.S.4.3 - Validation of Analytical Procedures Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298685
Title
module 3.2.S.4.3 - Annex 1 - Method 1061.057 - Validation Report (S-QCB-PROT-AMV-017-01-R02)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298686
Title
module 3.2.S.4.3 - Annex 2 - Method 1061.054 - Validation Report (MVD-GMP-QCB-FG-830002590-AMVR-0011)
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298687
Title
module 3.2.S.4.3 - Annex 3 - Method 1061.056 - Validation Report (CH6MZ-US-19-279)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298688
Title
module 3.2.S.4.3 - Annex 4 - Method 1061.056 - Analytical Method Transfer Report (MVD-GMP-QCB-FG-830002590-AMTR-0001)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298689
Title
module 3.2.S.4.3 - Annex 5 - Method 1061.055 - Validation Report (S-QCB-PROT-AMV-016-02-R01)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298690
Title
module 3.2.S.4.3 - Annex 6 - Method 1061.004 - Validation Report (MVD-GMP-QCB-FG-830002590-AMVR-0001)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298691
Title
module 3.2.S.4.3 - Annex 7 - Method 1061.004 - Comparability Report (CH6MW-US-21-395)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298692
Title
module 3.2.S.4.3 - Annex 8 - Method 1061.004 - Qualification Report (C667Z-US-22-515)
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298693
Title
module 3.2.S.4.3 - Annex 9 - Method 1061.004 - Evaluation Protocol
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298694
Title
module 3.2.S.4.3 - Annex 10 - Method 1061.005 - Validation Report (S-QCB-PROT-AMV-022-01-R01)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298695
Title
module 3.2.S.4.3 - Annex 11 - Method GM099 - Validation Report (VM296)
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298696
Title
module 3.2.S.4.4 - Batch Analyses Drug Substance
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298697
Title
module 3.2.S.4.5 - Drug Substance Specification Justification
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298698
Title
module 3.2.S.5 - Reference Standards or Materials
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298699
Title
module 3.2.S.6 - Container Closure System
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298700
Title
module 3.2.S.7.1 - Stability Summary and Conclusions
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298701
Title
module 3.2.S.7.2 - Post-Approval Stability Protocol
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298702
Title
module 3.2.S.7.3 - Primary Stability Data
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298703
Title
module 3.2.S.7.4 - Supportive Stability Data
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298704
Title
module 3.2.S.7.4 - Annex 1 - Stability Summary Report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298705
Title
module 3.2.S.7.4 - Annex 2 - Freeze Thaw Report
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298706
Title
module 3.2.S - Flowchart of Manufacturers
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298707
Title
module 3.2.S - GMP Certificate Site A
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298708
Title
module 3.2.S - GMP Certificate Site B
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298709
Title
module 3.2.S - GMP Certificate Site C
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298710
Title
module 3.2.S - GMP Certificate Site D
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298711
Title
module 3.2.S - GMP Certificate Site E
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298712
Title
module 3.2.S - GMP Certificate Site F
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298713
Title
module 3.2.S - Pharmacopoeial Monographs
Study date
2024
Auth party contact address
-
Data no
298714
Title
module 3.2.S - Day 180 Product Information
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298715
Title
module 3.2.S - ICH Q11
Study date
2012
Auth party contact address
-
Data no
298716
Title
module 3.2.S - Pharmacopoeial Test Methods
Study date
2024
Auth party contact address
-
Data no
298717
Title
Characterisation of endogenous retrovirus in rodent cell lines used for production of biologicals
Study date
2003
Auth party contact address
-
Data no
298718
Title
Calculation of Protein Extinction Coefficients form Amino Acid Sequence Data
Study date
1989
Auth party contact address
-
Data no
298719
Title
Scale-down model qualification of ambr 250 high-throughput mini bioreactor system for two commercial-scale mAb processes
Study date
2019
Auth party contact address
-
Data no
298720
Title
Protein deamidation
Study date
2002
Auth party contact address
-
Data no
298721
Title
Fragmentation of monoclonal antibodies
Study date
2011
Auth party contact address
-
Data no
298722
Title
Detecting DNA double-stranded breaks in mammalian genomes by linear amplification-mediated high-throughput genome-wide translocation sequencing
Study date
2016
Auth party contact address
-
Data no
298723
Title
Antibacterial polyphenols from olive oil mill waste waters
Study date
1995
Auth party contact address
-