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
144685
Product/Active constituent Name
Application Product Name
Bixafen
Application Date
Application Number
144685
Application Product Name
Bixafen
Application details
Product name:
Bixafen
Active name:
Bixafen
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of Bixafen for use in agricultural chemical products
Description of data provided:
Data no
274150
Title
Five Batch Analysis of Bixafen Technical
Study date
23/10/2020
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274153
Title
DoC
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274154
Title
The Statement of Batch Size of Bixafen Technical in 5-Batch Report
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274152
Title
THE JUSTIFICATION OF IMPURITIES OF BIXAFEN TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274151
Title
MANUFACTURE PROCESS OF BIXAFEN TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274149
Title
-
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
286244
Title
Bixafen TC Response to Section 159
Study date
7/2/2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274160
Title
Excutive summary
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274156
Title
BIXAFEN TECHNICAL: BACTERIAL REVERSE MUTATION TEST
Study date
20/10/2020
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274157
Title
Salmonella typhimurium, Reverse Mutation Assay of 3',4'-dichloro-5-fluoro-[1,1'-biphenyl]-2-amine
Study date
13/01/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274158
Title
In vitro Mammalian Cell Micronucleus Test of 3',4' dichloro-5-fluoro-[1,1'-biphenyl]-2-amine using Human Lymphoblastoid Cell Line (TK6)
Study date
13/01/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274159
Title
QSAR analysis for Bixafen and the related impurity 1
Study date
27 July 2021
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274155
Title
Evaluation report on the equivalence of technical material for the active substance
Study date
21/02/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
144537
Product/Active constituent Name
Application Product Name
Farmalinx Ransom Herbicide
Application Date
Application Number
144537
Application Product Name
Farmalinx Ransom Herbicide
Application details
Product name:
Farmalinx Ransom Herbicide
Product number:
95042
Applicant Name:
FARMALINX PTY LTD
Application purpose and description of use:
Registration of a 22.5 g/kg foramsulfuron Water Dispersible Granule product for post-emergent control of certain grass weeds in turf.
Reference details:
63240 - TRIBUTE SELECTIVE TURF HERBICIDE
88827 - Farmalinx Reign Herbicide
Active constituents:
Active constituent name
94243 - Foramsulfuron
Description of data provided:
Data no
273647
Title
Method Validation for the Determination of Foramsulfuron in a Water Dispersible Granule (WG)
Study date
31 May 2018
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273644
Title
Chemistry and Manufacturing Farmalinx Ransom Herbicide
Study date
June 2018
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273645
Title
Raw material specifications
Study date
June 2018
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273646
Title
Report of Anaylsis
Study date
June 2018
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273651
Title
Efficacy and Crop Safety Farmalinx Ransom Herbicide
Study date
June 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273654
Title
Evaluation of Farmalinx Herbicides for the control of weeds in turf
Study date
1 May 2019
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273655
Title
Evaluation of Experimental Herbicide Formulations for the control of weeds in turf
Study date
7 April 2020
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273652
Title
Proposed label
Study date
June 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273653
Title
Reference label
Study date
June 2024
Auth party contact address
-
Data no
273650
Title
Proposed RLP
Study date
June 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273648
Title
Toxicology and OHS Farmalinx Ransom Herbicide
Study date
June 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
273649
Title
Raw material SDS
Study date
June 2024
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Date
Application Date
Application No
Application Number
144463
Product/Active constituent Name
Application Product Name
Elevet+ Estrovet Prostaglandin Injection
Application Date
Application Number
144463
Application Product Name
Elevet+ Estrovet Prostaglandin Injection
Application details
Product name:
Elevet+ Estrovet Prostaglandin Injection
Product number:
95017
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Registration of a 250 µg/mL cloprostenol (as the sodium salt) injectable product as a luteolytic agent for clinical use
and the control of the bovine oestrus cycles.
Reference details:
49746 - ESTROPLAN FLEXI
Active constituents:
Active constituent name
91794 - Cloprostenol Sodium
Description of data provided:
Data no
273126
Title
Finished Product Specifications
Study date
June 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
144766
Product/Active constituent Name
Application Product Name
Agro-Essence Carfentrazone 400 EC herbicide
Application Date
Application Number
144766
Application Product Name
Agro-Essence Carfentrazone 400 EC herbicide
Application details
Product name:
Agro-Essence Carfentrazone 400 EC herbicide
Product number:
95131
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 400 g/L Carfentrazone-Ethyl Emulsifiable Concentrate (EC) product for Improvement in the Control of Marshmallow and Certain Other Broadleaf Weeds Prior to Establishment of Broadacre Crops, Fallows or Forest Plantations, in Commercial, Industrial and Public Service Areas, Around Agricultural Buildings And Yards, in Tree Fruits, Nuts, Grape Vines in Tank Mixture With Knockdown Herbicides; Control of Marshmallow and Annual Nettles in Grass Pastures and Rough Grass/Turf Areas; And Control of Volunteer Cotton Seedlings Including Roundup Ready® Cotton And Desiccation of Cotton Re- growth
Reference details:
87056 - F.S.A. Carfentrazone 400 Herbicide
Active constituents:
Active constituent name
68094 - CARFENTRAZONE-ETHYL
Date
Application Date
Application No
Application Number
144042
Product/Active constituent Name
Application Product Name
COOPERS GUARDIAN 6IN1 VACCINE FOR SHEEP + SELENIUM FOR LAMBS
Application Date
Application Number
144042
Application Product Name
COOPERS GUARDIAN 6IN1 VACCINE FOR SHEEP + SELENIUM FOR LAMBS
Application details
Product name:
COOPERS GUARDIAN 6IN1 VACCINE FOR SHEEP + SELENIUM FOR LAMBS
Product number:
46580
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to rationalise in-process and final product tests and update the product label.
Active constituents:
Active constituent name
55115 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
55082 - CLOSTRIDIUM NOVYI TYPE B
Active constituent name
55088 - CLOSTRIDIUM SEPTICUM - KILLED
Active constituent name
55085 - CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN
Active constituent name
57149 - CLOSTRIDIUM CHAUVOEI - TOXOID
Active constituent name
57560 - SELENIUM AS SODIUM SELENITE
Active constituent name
85838 - CLOSTRIDIUM TETANI TOXOID
Active constituent name
85807 - CLOSTRIDIUM PERFRINGENS TYPE D TOXOID
Active constituent name
85858 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS TOXIOD AND INACTIVATED CELLS
Active constituent name
55882 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS - TOXOID
Active constituent name
85766 - CLOSTRIDIUM CHAUVOEI (INACTIVATED)
Active constituent name
85798 - CLOSTRIDIUM NOVYI TYPE B (Inactivated)
Active constituent name
85813 - CLOSTRIDIUM NOVYI TYPE B TOXOID AND INACTIVATED CELLS
Active constituent name
85815 - CLOSTRIDIUM CHAUVOEI TOXIOD AND INACTIVATED CELLS
Active constituent name
85831 - CLOSTRIDIUM SEPTICUM TOXOID
Description of data provided:
Data no
271786
Title
Variation 1 proposal for Cl. chauvoei test rationalisation.
Study date
May 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
281078
Title
s159 Applicant Response 13 November 2024
Study date
13 November 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
287401
Title
3x COA for Coopers Guardian 6 in 1 for sheep and lambs.
3x COA for Coopers Guardian 6 in 1 plus selenium for lambs.
3x COA for Coopers Guardian 6 in 1 plus selenium for lambs.
Study date
Dec 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
287402
Title
RTQ on s159 notice dated 29 May 2025
Study date
10 June 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
287403
Title
Applicant response on formulation for Coopers Guardian 6 and Coopers Guardian 6 + Selenium.
Study date
31 January 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
144654
Product/Active constituent Name
Application Product Name
POVIDINE ANTISEPTIC OINTMENT 10% w/w
Application Date
Application Number
144654
Application Product Name
POVIDINE ANTISEPTIC OINTMENT 10% w/w
Application details
Product name:
POVIDINE ANTISEPTIC OINTMENT 10% w/w
Product number:
95094
Applicant Name:
INNOVATIVE PHARMA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a topical ointment containing 100 mg/g Povidone-Iodine for the treatment of wound and skin infections caused by bacteria and fungi in horses and dogs.
Reference details:
62637 - VETEDINE OINTMENT
38561 - TROY IODIN SPRAY SKIN & WOUND DRESSING
47834 - PVP-IODINE SOLUTION
36258 - FARNAM BUFFERED IODINE SPRAY
45430 - ANTISEPTIC QUIT-ITCH LOTION BACTERICIDE - FUNGICIDE
62936 - AUSTRALIAN MADE AUSTRALIAN OWNED SAINT BERNARD PETCARE STOP ITCH BROAD SPECTRUM ANTISEPTIC SKIN TREATMENT FOR SKIN CARE OF DOGS, CATS AND HORSES
68944 - ARISTOPET ANIMAL HEALTH STOP-ITCH FOR DOGS & CATS
Active constituents:
Active constituent name
86054 - Povidone (PVP) Iodine
Description of data provided:
Data no
274028
Title
Certificate of Analysis and Other Information - Active Constituent
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274033
Title
Document SYM-IP_VP_001 Validation Method for Therapeutic and Pharmaceutical testing
Study date
02 March 2023
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274034
Title
Validation Reference SYMP-IP-VAL001: Pharmaceutical Product Validation Report
Study date
23 January 2023
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274035
Title
Validation Protocol - Determination of Iodine in Povidone-Iodine Ointment
Study date
26 November 2020
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274036
Title
Attachment 2-9 Method Validation Report USP Povidone-Iodine Ointment
Study date
19 March 2021
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274030
Title
Certificates of Analysis - Finished Product
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274027
Title
POVIDINE ANTISEPTIC OINTMENT 10% w/w ITEM 10: New Product, Existing Active Constituents, Similar Decision ID: DC10-38280898
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274037
Title
Packaging Material Specifications
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274029
Title
Certificates of Analysis -Excpients
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274021
Title
USP-NF Povidone-Iodine Ointment
Study date
2024
Auth party contact address
-
Data no
274031
Title
Stability Data Part 1 - Physical and Chemical Testing & Microbiological Test Results
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274032
Title
Preservative Efficacy Tests
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274023
Title
TGA Disnfectant Test Povidone Iodine 10% w/w Antipseptic Ointment
Study date
3 March 2024
Auth party contact address
27 Norfolk Road Epping Australia
Data no
274024
Title
Skin asepsis protocols as a preventive measure of surgical site infections in dogs: chlorhexidine alcohol versus povidone iodine
Study date
2018
Auth party contact address
-
Data no
274025
Title
Effectiveness of chlorhexidine diacetate and povidone-iodine in antiseptic preparation of the canine external ear canal prior to total ear canal ablation with bulla osteotomy procedure: A preliminary study
Study date
2023
Auth party contact address
-
Data no
274026
Title
Comparative clinical effectiveness of preoperative skin antiseptic preparations of chlorhexidine gluconate and povidone iodine for preventing surgical site infections in dogs
Study date
2018
Auth party contact address
-
Data no
274022
Title
ATTACHMENT 2 - POVIDINE ANTISEPTIC OINTMENT 10% w/w Executive Summary Decision ID: DC10-38280898
Study date
July 2024
Auth party contact address
27 Norfolk Road Epping Australia
Date
Application Date
Application No
Application Number
144747
Product/Active constituent Name
Application Product Name
Titan Amitrole 250 SL Herbicide
Application Date
Application Number
144747
Application Product Name
Titan Amitrole 250 SL Herbicide
Application details
Product name:
Titan Amitrole 250 SL Herbicide
Product number:
88549
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add uses as per reference product.
Reference details:
31236 - NUFARM AMITROLE T HERBICIDE
Active constituents:
Active constituent name
68136 - AMITROLE
Description of data provided:
Data no
274397
Title
Safety data sheet
Study date
April 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
144499
Product/Active constituent Name
Application Product Name
Levamisole Hydrochloride
Application Date
Application Number
144499
Application Product Name
Levamisole Hydrochloride
Application details
Product name:
Levamisole Hydrochloride
Active name:
Levamisole Hydrochloride
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
274040
Title
Active Certificates of analysis
Study date
2023
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
144729
Product/Active constituent Name
Application Product Name
Ezycrop Glufosinate 200 Herbicide
Application Date
Application Number
144729
Application Product Name
Ezycrop Glufosinate 200 Herbicide
Application details
Product name:
Ezycrop Glufosinate 200 Herbicide
Product number:
95115
Applicant Name:
EZYCROP PTY LTD
Application purpose and description of use:
Registration of a 200 g/L Glufosinate-ammonium soluble concentrate formulation product for the non-residual
control of broadleaf and grass weeds in various situations as indicated in the Directions for Use table.
Reference details:
91136 - AgMerch Glufosinate 200 Herbicide
Active constituents:
Active constituent name
64470 - GLUFOSINATE-AMMONIUM
Active constituent name
64779 - GLUFOSINATE-AMMONIUM
Date
Application Date
Application No
Application Number
144734
Product/Active constituent Name
Application Product Name
SHARP SHOOTER ENVIRO PEST OIL CONCENTRATE
Application Date
Application Number
144734
Application Product Name
SHARP SHOOTER ENVIRO PEST OIL CONCENTRATE
Application details
Product name:
SHARP SHOOTER ENVIRO PEST OIL CONCENTRATE
Product number:
61849
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration alter the product name and amend the formulation details..
Reference details:
46889 - YATES WHITE OIL INSECTICIDE
Active constituents:
Active constituent name
59840 - PETROLEUM OIL
Date
Application Date
Application No
Application Number
144530
Product/Active constituent Name
Application Product Name
Triclabendazole
Application Date
Application Number
144530
Application Product Name
Triclabendazole
Application details
Product name:
Triclabendazole
Active name:
Triclabendazole
Applicant Name:
KSJ GROUP PTY LTD
Application purpose and description of use:
Approval of Triclabendazole for use in veterinary chemical products.
Description of data provided:
Data no
273591
Title
Certificate of Analysis
Study date
2024
Auth party contact address
Unit - 9, 7 Anella Avenue CASTLE HILL Australia
Data no
273592
Title
European Pharmacopeia Monograph
Study date
2024
Auth party contact address
Unit - 9, 7 Anella Avenue CASTLE HILL Australia
Date
Application Date
Application No
Application Number
144498
Product/Active constituent Name
Application Product Name
LEVACARE LV ORAL DRENCH
Application Date
Application Number
144498
Application Product Name
LEVACARE LV ORAL DRENCH
Application details
Product name:
LEVACARE LV ORAL DRENCH
Product number:
95029
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
Registration of 80 g/L Levamisole Hydrochloride Oral Drench product is proposed for the control of levamisole sensitive round worms including lungworms in sheep and cattle and for the treatment of sensitive strains of round worms in pigs and poultry.
Reference details:
36152 - COOPERS NILVERM LV ORAL WORMER
Active constituents:
Active constituent name
95030 - Levamisole Hydrochloride
Description of data provided:
Data no
273379
Title
Finished Product specs
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
279286
Title
Finished product specifications V2
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
279287
Title
Response to s159 notice
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
144660
Product/Active constituent Name
Application Product Name
Porcilis Lawsonia Inactivated Vaccine for Pigs
Application Date
Application Number
144660
Application Product Name
Porcilis Lawsonia Inactivated Vaccine for Pigs
Application details
Product name:
Porcilis Lawsonia Inactivated Vaccine for Pigs
Product number:
91351
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add a new product manufacturer for solvent manufacture for finished product
Active constituents:
Active constituent name
91350 - Lawsonia intracellularis strain SPAH-08
Description of data provided:
Data no
283709
Title
Non-standard conditions updated
Study date
4 February 2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274060
Title
Control tests during the manufacturing process-tracked changes
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274061
Title
Control tests on the finished products-tracked changes
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274068
Title
KRE-VAL_R-Sterility_LFD_solvent-RA Vers. 2.0 - Method verification summary report
Study date
25 October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274069
Title
KRE-VAL_R-Aluminium_LFD_solvent-RA Vers. 2.0 - Method verification summary report
Study date
7 September 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274070
Title
KRE-TRA_R-FPU_LFD-solvent-RA - Transfer Report
Study date
30 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274071
Title
SOP GRA-TI-QC-507[EN] Vers 2.0 - Determination of viscosity
Study date
20 July 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274072
Title
SOP TI-4066-0019 rev 02 - Determination of aluminium
Study date
28 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274073
Title
SOP TI-4066-0024 - pH measurement of vaccines
Study date
26 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274074
Title
SOP TI-5089-0002 - Sterility test direct innoculation
Study date
24 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274062
Title
Batch protocol 3E002A
Study date
21 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274063
Title
Batch protocol 3E003A
Study date
21 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274064
Title
Batch protocol 3E004A
Study date
21 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274065
Title
Batch protocol A134A
Study date
30 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274066
Title
Batch protocol A135A
Study date
30 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274067
Title
Batch protocol A137A
Study date
30 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274058
Title
Comparitive batch data table
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274059
Title
Description of the manufacturing method-tracked changes
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283710
Title
MSD response to s159 cover letter
Study date
4 February 2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283711
Title
Porcilis Lawsonia P2c production and control of starting materials
Study date
March 2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283712
Title
Raw data sterility test_LFD solvent
Study date
10 November 2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283713
Title
Steps of product manufacture_updated_Site 1
Study date
4 February 2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283714
Title
Steps of product manufacture_updated_Site 2
Study date
4 February 2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274051
Title
Executive Summary
Study date
1 July 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274052
Title
Manufacturing sites flowchart
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274053
Title
GMP additional site
Study date
7 June 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274054
Title
Manufacturing Authorisation
Study date
8/6/2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274055
Title
GMP current manufacturer
Study date
22 January 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274056
Title
Overview of release and end of shelf life specifications
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
274057
Title
Additional detailed and critical summary on quality.
Study date
October 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
144404
Product/Active constituent Name
Application Product Name
Starkle 700 WG Insecticide
Application Date
Application Number
144404
Application Product Name
Starkle 700 WG Insecticide
Application details
Product name:
Starkle 700 WG Insecticide
Product number:
94991
Applicant Name:
AGNOVA TECHNOLOGIES PTY LTD
Application purpose and description of use:
Registration of a 700 g/kg dinotefuran wettable granule (WG) product for the control of silverleaf whitefly, green mirid and shield bugs on cotton and green mirid on mung beans as per the Directions for Use table
Reference details:
69396 - DINOTEFURAN
69398 - STARKLE 200 SG INSECTICIDE
Active constituents:
Active constituent name
69396 - DINOTEFURAN
Description of data provided:
Data no
273267
Title
Validation of an Analytical Method for the Determination of MTI-446 (active ingredient) in MTI-446 20%SG.
Study date
2001
Data no
273268
Title
Starkle 700 WG Insecticide Part 2 Chemistry May 2024
Study date
2024
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273269
Title
CP1 Physical Properties of Dinotefuran 70%WG.
Study date
2018
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273270
Title
CP3 Dinotefuran 70 WG: Determination of Density and Odor.
Study date
2019
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273271
Title
CP4 Observation of Odor for Dinotefuran 70WG.
Study date
2019
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273272
Title
CP5 Dinotefuran 70 WG: Determination of Hazardous Physico-Chemical Properties.
Study date
2019
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273273
Title
Doc J Confidential Chemistry Data for Starkle 700 WG Insecticide May 2024
Study date
2024
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273274
Title
CP2 Physical Properties of Dinotefuran 70%WG ? Report Amendment No. 1.
Study date
2019
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273275
Title
CP6 Dinotefuran 70 WG Accelerated Storage Stability (analysis of the active ingredient content). Tamgawa, Yasushi.
Study date
2023
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273276
Title
CP8 Dinotefuran 70 WG: Determination of Accelerated Storage Stability.
Study date
2019
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273277
Title
Dinotefuran: Determination and Certification of the Content in Dinotefuran 70% WP.
Study date
2009
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273234
Title
Stability Testing of AgNova Dinotefuran 70WG.
Study date
2024
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
281981
Title
Starkle 700 WG Part 8 - Additional Document Dec 2024
Study date
Dec 2024
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273216
Title
Starkle 700 WG Part 8 Efficacy & Crop Safety
Study date
2024
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273217
Title
Evaluation of Various Insecticides for Use in Cotton. 512
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273219
Title
Evaluation of Various Insecticides for Silverleaf Whitefly Control. 478
Study date
2022
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273220
Title
Evaluation of Various Insecticides for Use in Cotton. 575
Study date
2023
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273221
Title
Evaluation of Various Insecticides for Use in Cotton. 580
Study date
2023
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273222
Title
Evaluation of Various Insecticides for Use in Summer Legumes. 546
Study date
2023
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273223
Title
Starkle for Green Vegetable Bug Control in Mung Beans ??? Field Bioassay KA17-990
Study date
2016
Data no
273224
Title
Green Vegetable Bug Cotton Bioassay KA16-1314
Study date
2016
Data no
273225
Title
Starkle in Mung Beans for Mirid Control 008-16-H3-16 KA16-1284
Study date
2016
Data no
273226
Title
Starkle in Mung Beans for Mirid Control 008-16-H3-16 KA16-1285
Study date
2016
Data no
273227
Title
Starkle in Mung bean for Mirid control 008-16-H3-16 KA16-1282
Study date
2016
Data no
273228
Title
Green Vegetable Bug Cotton Bioassay KA16-1313
Study date
2016
Data no
273229
Title
Impact of insecticides on the invasive Halyomorpha halys: Analysis of insecticide lethality.
Study date
2012
Auth party contact address
-
Data no
273230
Title
Toxicity of insecticides to Halyomorpha halys using glass-vial bioassay
Study date
2008
Auth party contact address
-
Data no
273231
Title
Impact of insecticides residue exposure on the invasive pest, Halyomorpha halys: Analysis of adult mobility
Study date
2013
Auth party contact address
-
Data no
273232
Title
The consequences of sub-lethal exposure to insecticides on the survivorship and mobility of Halyomorpha halys
Study date
2017
Auth party contact address
-
Data no
273218
Title
Evaluation of Various Insecticides for Use in Cotton
Study date
2022
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273233
Title
Starkle 700 WG Part 6 OH&S May 2024
Study date
2024
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
273278
Title
TP2 Acute Dermal Dose Toxicity Study of Dinotefuran 70WG in Sprague-Dawley Rats.
Study date
2017
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273279
Title
TP4 Acute Eye Irritation/Corrosion Study of Dinotefuran 70WG in New Zealand White Rabbits.
Study date
2017
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273280
Title
TP3 Dinotefuran70WG: Acute Inhalation Toxicity Study in Sprague-Dawley Rats.
Study date
2017
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273281
Title
TP1 Acute Oral Dose Toxicity Study of Dinotefuran 70WG in Sprague-Dawley Rats (Acute Toxic Class Method).
Study date
2017
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273282
Title
TP5 Acute Skin Irritation/Corrosion Study of Dinotefuran 70WG in New Zealand White Rabbits.
Study date
2017
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273283
Title
TP6 Skin Sensitisation Test of Dinotefuran 70 WG in CBA/J Mice (Local Lymph Node Assay: BrdU-ELISA).
Study date
2017
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273284
Title
Starkle 700 WG Insecticide Part 3 Toxicology Apr 2024
Study date
2024
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273285
Title
TP7 [14C]MTI-446: Dermal Absorption of [14C] MTI-446 Formulated as Aqueous Solution in the Rat (In Vivo).
Study date
2006
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Data no
273286
Title
TP8 The In Vitro Percutaneous Absorption of Radiolabelled Dinotefuran in a 20% Water-Soluble Granule (SG) Formulation and a Single In-Use Dilution Through Human Split-Thickness Skin (OECD 428).
Study date
2021
Auth party contact address
1-19-1, Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
Date
Application Date
Application No
Application Number
144037
Product/Active constituent Name
Application Product Name
COOPERS GUARDIAN 6IN1 VACCINE FOR SHEEP AND LAMBS
Application Date
Application Number
144037
Application Product Name
COOPERS GUARDIAN 6IN1 VACCINE FOR SHEEP AND LAMBS
Application details
Product name:
COOPERS GUARDIAN 6IN1 VACCINE FOR SHEEP AND LAMBS
Product number:
46578
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to rationalise in-process and final product tests and update the product label.
Active constituents:
Active constituent name
55115 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
55088 - CLOSTRIDIUM SEPTICUM - KILLED
Active constituent name
55085 - CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN
Active constituent name
57149 - CLOSTRIDIUM CHAUVOEI - TOXOID
Active constituent name
55882 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS - TOXOID
Active constituent name
55982 - PROPYZAMIDE
Active constituent name
85831 - CLOSTRIDIUM SEPTICUM TOXOID
Active constituent name
85838 - CLOSTRIDIUM TETANI TOXOID
Active constituent name
85807 - CLOSTRIDIUM PERFRINGENS TYPE D TOXOID
Active constituent name
85858 - CORYNEBACTERIUM PSEUDOTUBERCULOSIS TOXIOD AND INACTIVATED CELLS
Active constituent name
55082 - CLOSTRIDIUM NOVYI TYPE B
Active constituent name
55982 - PROPYZAMIDE
Active constituent name
85766 - CLOSTRIDIUM CHAUVOEI (INACTIVATED)
Active constituent name
85798 - CLOSTRIDIUM NOVYI TYPE B (Inactivated)
Active constituent name
85813 - CLOSTRIDIUM NOVYI TYPE B TOXOID AND INACTIVATED CELLS
Active constituent name
85815 - CLOSTRIDIUM CHAUVOEI TOXIOD AND INACTIVATED CELLS
Description of data provided:
Data no
271769
Title
Variation 2 proposal for Cl. chauvoei test rationalisation
Study date
May 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
271768
Title
Variation 1 proposal for Residual toxicity test removal
Study date
April 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
144692
Product/Active constituent Name
Application Product Name
Amoxicillin trihydrate
Application Date
Application Number
144692
Application Product Name
Amoxicillin trihydrate
Application details
Product name:
Amoxicillin trihydrate
Active name:
Amoxicillin trihydrate
Applicant Name:
VETOQUINOL AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of active for use in veterinary chemical products.
Description of data provided:
Data no
274288
Title
Certificate of Analysis
Study date
2022
Auth party contact address
Level 2 485 Kingsford Smith Drive Hamilton Australia
Data no
274289
Title
Certificate of Suitability
Study date
2020
Auth party contact address
Level 2 485 Kingsford Smith Drive Hamilton Australia
Data no
274290
Title
Pharmacopoeia Standard
Study date
2013
Auth party contact address
Level 2 485 Kingsford Smith Drive Hamilton Australia
Date
Application Date
Application No
Application Number
144342
Product/Active constituent Name
Application Product Name
TIM-BOR INDUSTRIAL WOOD PRESERVATIVE
Application Date
Application Number
144342
Application Product Name
TIM-BOR INDUSTRIAL WOOD PRESERVATIVE
Application details
Product name:
TIM-BOR INDUSTRIAL WOOD PRESERVATIVE
Product number:
51573
Applicant Name:
US Borax Inc
Application purpose and description of use:
Variation of product registration for label approval to update nominated agent details on label in e-file format and add a 907 kg pack size
Description of data provided:
Data no
272638
Title
TIM-BOR INDUSTRIAL WOOD PRESERVATIVE
Study date
2001-12-04
Auth party contact address
14486 Borax Road BORON United States
Date
Application Date
Application No
Application Number
144693
Product/Active constituent Name
Application Product Name
Yates Weed ‘n’ Feed Weed Killer and Lawn Fertiliser Granular
Application Date
Application Number
144693
Application Product Name
Yates Weed ‘n’ Feed Weed Killer and Lawn Fertiliser Granular
Application details
Product name:
Yates Weed ‘n’ Feed Weed Killer and Lawn Fertiliser Granular
Product number:
93091
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to change the formulation and remove fertiliser related claims
Active constituents:
Active constituent name
57324 - IRON AS FERROUS SULFATE
Description of data provided:
Data no
274291
Title
Executive summary
Study date
08 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
274292
Title
Label amendments
Study date
02 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
274293
Title
SDS
Study date
13 June 2023
Auth party contact address
1 GOW ST PADSTOW Australia
Date
Application Date
Application No
Application Number
144694
Product/Active constituent Name
Application Product Name
Yates Weed ‘n’ Feed Buffalo Lawn Weed Killer and Lawn Fertiliser Granular
Application Date
Application Number
144694
Application Product Name
Yates Weed ‘n’ Feed Buffalo Lawn Weed Killer and Lawn Fertiliser Granular
Application details
Product name:
Yates Weed ‘n’ Feed Buffalo Lawn Weed Killer and Lawn Fertiliser Granular
Product number:
93092
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to Yates Weed ‘n’ Feed Buffalo Lawn Weed Killer and Lawn Fertiliser Granular.
Active constituents:
Active constituent name
57324 - IRON AS FERROUS SULFATE
Description of data provided:
Data no
274294
Title
Executive summary
Study date
08 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
274295
Title
Label amendments
Study date
02 July 2024
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
274296
Title
SDS
Study date
13 June 2023
Auth party contact address
1 GOW ST PADSTOW Australia
Date
Application Date
Application No
Application Number
144570
Product/Active constituent Name
Application Product Name
VETSENSE Birdcare 3C Antibiotic for Ornamental Birds
Application Date
Application Number
144570
Application Product Name
VETSENSE Birdcare 3C Antibiotic for Ornamental Birds
Application details
Product name:
VETSENSE Birdcare 3C Antibiotic for Ornamental Birds
Product number:
95060
Applicant Name:
VETSENSE PTY LTD
Application purpose and description of use:
Registration of a 100mg/g chlortetracycline hydrochloride soluble powder for the treatment of organisms susceptible to Chlortetracycline
Reference details:
52851 - VETAFARM TRIPLE C ANTIBIOTIC FOR ORNAMENTAL BIRDS
Active constituents:
Active constituent name
95061 - Chlortetracycline hydrochloride
Description of data provided:
Data no
273714
Title
Excipient CoAs
Study date
2023
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
273715
Title
Finish Product Specs
Study date
2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia