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
147638
Product/Active constituent Name
Application Product Name
Quantum Triallate 500 EC Herbicide
Application Date
Application Number
147638
Application Product Name
Quantum Triallate 500 EC Herbicide
Application details
Product name:
Quantum Triallate 500 EC Herbicide
Product number:
95928
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 500 g/L Tri-allate emulsifiabe concentrate product for the control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower as per Directions for Use.
Reference details:
67488 - SABAKEM TRIALLATE 500EC HERBICIDE
Active constituents:
Active constituent name
68961 - TRI-ALLATE
Active constituent name
44433 - TRI-ALLATE
Description of data provided:
Data no
284498
Title
Executive Summary
Study date
February 2025
Auth party contact address
Suite 2, Level 7, 330 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
147645
Product/Active constituent Name
Application Product Name
Quantum Flupropanate 745 SL Herbicide
Application Date
Application Number
147645
Application Product Name
Quantum Flupropanate 745 SL Herbicide
Application details
Product name:
Quantum Flupropanate 745 SL Herbicide
Product number:
95935
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 745 g/L Flupropanate Soluble concentrate (SL) product for A component of integrated management of serrated tussock, giant parramatta grass, giant rat’s tail grass, Chilean needle grass, African lovegrass and certain grasses as per the directions for use table.
Reference details:
83153 - GP FluPro 745 SL Herbicide
Active constituents:
Active constituent name
67742 - FLUPROPANATE-SODIUM
Date
Application Date
Application No
Application Number
147329
Product/Active constituent Name
Application Product Name
Wynca Metribuzin 750 WG Herbicide
Application Date
Application Number
147329
Application Product Name
Wynca Metribuzin 750 WG Herbicide
Application details
Product name:
Wynca Metribuzin 750 WG Herbicide
Product number:
95839
Applicant Name:
ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD
Application purpose and description of use:
Registration of WYNCA METRIBUZIN 750 WG HERBICIDE for Selective Weed Control in Cereals, Pastures and other Crops, including Vegetables.
Reference details:
67153 - Bar 750 WG Herbicide
Active constituents:
Active constituent name
70402 - METRIBUZIN
Active constituent name
94877 - Metribuzin
Date
Application Date
Application No
Application Number
147634
Product/Active constituent Name
Application Product Name
Quantum Trifluralin 480 EC Herbicide
Application Date
Application Number
147634
Application Product Name
Quantum Trifluralin 480 EC Herbicide
Application details
Product name:
Quantum Trifluralin 480 EC Herbicide
Product number:
95926
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 480 g/L Trifluralin emulsifiable concentrate product for use as a pre-emergence herbicide for the control of annual grasses and broadleaf weeds in horticultural and agricultural crops as per the Directions for Use Table.
Reference details:
67329 - SABAKEM TRIFLURALIN 480EC SELECTIVE HERBICIDE
Active constituents:
Active constituent name
59597 - TRIFLURALIN
Active constituent name
81751 - Trifluralin
Active constituent name
69881 - TRIFLURALIN
Active constituent name
89190 - Trifluralin
Description of data provided:
Data no
284499
Title
Executive Summary
Study date
February 2025
Auth party contact address
Suite 2, Level 7, 330 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
147644
Product/Active constituent Name
Application Product Name
Quantum Glyphosate 700 SG Herbicide
Application Date
Application Number
147644
Application Product Name
Quantum Glyphosate 700 SG Herbicide
Application details
Product name:
Quantum Glyphosate 700 SG Herbicide
Product number:
95934
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 700g/kg GLYPHOSATE present as the mono-ammonium salt water soluble granule (SG) product for A non-selective herbicide for the control of many annual and perennial weeds in certain situations as are indicates in the directions for use.
Reference details:
66687 - AW REK HERBICIDE
Active constituents:
Active constituent name
51693 - GLYPHOSATE
Active constituent name
69234 - GLYPHOSATE
Date
Application Date
Application No
Application Number
147631
Product/Active constituent Name
Application Product Name
Quantum Propiconazole 250 EC Fungicide
Application Date
Application Number
147631
Application Product Name
Quantum Propiconazole 250 EC Fungicide
Application details
Product name:
Quantum Propiconazole 250 EC Fungicide
Product number:
95924
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 250 g/L Propiconazole emulsifiable Concentrate product for the control of Certain Fungal Diseases of Bananas, Oats, Peanuts, Perennial Ryegrass, Pineapples, Stone Fruit, Sugarcane, Wheat and other crops as specified in the Directions for Use.
Reference details:
84527 - SABAKEM PROPICONAZOLE 250EC FUNGICIDE
Active constituents:
Active constituent name
67318 - PROPICONAZOLE
Active constituent name
59611 - PROPICONAZOLE
Active constituent name
65025 - PROPICONAZOLE
Active constituent name
69316 - PROPICONAZOLE
Description of data provided:
Data no
284497
Title
Executive Summary
Study date
February 2025
Auth party contact address
Suite 2, Level 7, 330 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
147040
Product/Active constituent Name
Application Product Name
Quantum Terbuthylazine 875 WG Herbicide
Application Date
Application Number
147040
Application Product Name
Quantum Terbuthylazine 875 WG Herbicide
Application details
Product name:
Quantum Terbuthylazine 875 WG Herbicide
Product number:
95741
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 875 g/kg Terbuthylazine water dispersible granule product for the control of weeds in barley, oats, wheat, chickpeas, faba beans, fallows, field peas, lentils, lupins, sorghum and triazine tolerant canola as per the directions for use table
Reference details:
88351 - Sabakem Terbuthylazine 875 WG Herbicide
Active constituents:
Active constituent name
80351 - TERBUTHYLAZINE
Active constituent name
65352 - TERBUTHYLAZINE
Active constituent name
66626 - TERBUTHYLAZINE
Date
Application Date
Application No
Application Number
147163
Product/Active constituent Name
Application Product Name
GSP RootShield 500 SC Herbicide
Application Date
Application Number
147163
Application Product Name
GSP RootShield 500 SC Herbicide
Application details
Product name:
GSP RootShield 500 SC Herbicide
Product number:
95784
Applicant Name:
GSP CROP SCIENCE LIMITED
Application purpose and description of use:
Registration of a 500 g/L propyzamide suspension concentrate product for selective control of certain grasses and broad leaf weeds in Canola, Lettuce, Sports Turf, Home Lawns and Legumes Seed Crops, Pastures and other crops
Reference details:
87920 - F.S.A. Propyzamide 500 SC Herbicide
Active constituents:
Active constituent name
64983 - PROPYZAMIDE
Date
Application Date
Application No
Application Number
147176
Product/Active constituent Name
Application Product Name
Quantum Chlorpyrifos 500 EC Insecticide
Application Date
Application Number
147176
Application Product Name
Quantum Chlorpyrifos 500 EC Insecticide
Application details
Product name:
Quantum Chlorpyrifos 500 EC Insecticide
Product number:
95791
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 500 g/L CHLORPYRIFOS emulsifiable concentrate (EC) product for the control of certain insect pests in various situations as per the directions for use table. THIS PRODUCT IS TOO HAZARDOUS FOR USE BY HOUSEHOLDERS
Reference details:
67451 - SABAKEM CHLORPYRIFOS 500EC INSECTICIDE
Active constituents:
Active constituent name
65331 - CHLORPYRIFOS
Active constituent name
46888 - CHLORPYRIFOS
Active constituent name
93565 - Chlorpyrifos
Date
Application Date
Application No
Application Number
147564
Product/Active constituent Name
Application Product Name
Agro-Essence Pyriproxyfen 100 EC Insecticide
Application Date
Application Number
147564
Application Product Name
Agro-Essence Pyriproxyfen 100 EC Insecticide
Application details
Product name:
Agro-Essence Pyriproxyfen 100 EC Insecticide
Product number:
95903
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 100 g/L Pyriproxyfen Emulsifiable Concentrate (EC) for the Control of Silverleaf Whitefly (Bemisia tabaci Biotype B) in Cotton
The Control of Silverleaf Whitefly (Bemisia tabaci Biotype B) and Greenhouse Whitefly In Tomatoes, Rockmelon and Capsicum, and the Control of Various Scale in Citrus, Mangoes and Olives
Reference details:
82036 - eChem Pyrip 100 Insect Growth Regulator
Active constituents:
Active constituent name
67716 - PYRIPROXYFEN
Date
Application Date
Application No
Application Number
147042
Product/Active constituent Name
Application Product Name
Quantum Isoxaflutole 750 WG Herbicide
Application Date
Application Number
147042
Application Product Name
Quantum Isoxaflutole 750 WG Herbicide
Application details
Product name:
Quantum Isoxaflutole 750 WG Herbicide
Product number:
95743
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 750 g/kg Isoxaflutole water dispersible granule product for the control and suppression of various broadleaf weeds and grasses in sugarcane and chickpeas as specified in the Directions For Use Table
Reference details:
86524 - Sabakem Isoxaflutole 750 WG Herbicide
Active constituents:
Active constituent name
69135 - ISOXAFLUTOLE
Date
Application Date
Application No
Application Number
147628
Product/Active constituent Name
Application Product Name
Munns Professional Nutgrass, Mullumbimby Couch and Broadleaf Weed Killer Specialty Lawn Weed Control Controls Hard to Kill Weeds Suitable for All Lawns
Application Date
Application Number
147628
Application Product Name
Munns Professional Nutgrass, Mullumbimby Couch and Broadleaf Weed Killer Specialty Lawn Weed Control Controls Hard to Kill Weeds Suitable for All Lawns
Application details
Product name:
Munns Professional Nutgrass, Mullumbimby Couch and Broadleaf Weed Killer Specialty Lawn Weed Control Controls Hard to Kill Weeds Suitable for All Lawns
Product number:
95922
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 480 g/L BENTAZONE present as sodium salt soluble concentration product for controlling Nutgrass, Mullumbimby Couch and certain Broadleaf Weeds in Turf as specified in the Directions for Use table.
Reference details:
90028 - Quali-Pro Nutmeg Herbicide
Active constituents:
Active constituent name
87560 - bentazone
Active constituent name
63533 - BENTAZONE
Description of data provided:
Data no
284434
Title
Executive summary
Study date
25 Feb 2025
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
284435
Title
Letter of Support (LoS)
Study date
Feb 2025
Auth party contact address
Rucha Harshe
Date
Application Date
Application No
Application Number
147583
Product/Active constituent Name
Application Product Name
MCPB
Application Date
Application Number
147583
Application Product Name
MCPB
Application details
Product name:
MCPB
Active name:
MCPB
Applicant Name:
Shanghai Hanfu Biotechnology Co., Ltd
Application purpose and description of use:
Approval of MCPB for use in agricultural chemical products.
Description of data provided:
Data no
284348
Title
Five batch analysis of MCPB TC (part 1)
Study date
January 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284359
Title
NS240164009 (part1)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284362
Title
NS250009001 (part 1)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284357
Title
NS240159001 (part 1)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284351
Title
Declaration of composition
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284354
Title
NS240148001 (part 2)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284360
Title
NS240164009 (part2)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284352
Title
Declaration of composition
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284355
Title
NS240148002 (part 1)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284361
Title
NS250009001 (part 1)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284349
Title
Five batch analysis of MCPB TC (part 12
Study date
January 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284358
Title
NS240159001 (part 2)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284350
Title
For approval of a new source of MCPB technical constituent
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284353
Title
NS240148001 (part 1)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284347
Title
Five batch analysis of MCPB TC
Study date
January 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Data no
284356
Title
NS240148002 (part 2)
Study date
February 2025
Auth party contact address
Room 308 No. 106 Zhongjiang Road Putuo District China
Date
Application Date
Application No
Application Number
147378
Product/Active constituent Name
Application Product Name
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Very Large Dogs
Application Date
Application Number
147378
Application Product Name
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Very Large Dogs
Application details
Product name:
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Very Large Dogs
Product number:
95857
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 600 mg fluralaner, 300 mg pyrantel and 1.5 mg moxidectin chewable tablet for the control of fleas, ticks, heartworm and internal parasites of dogs.
Reference details:
68873 - BRAVECTO 1400 MG FLURALANER CHEWABLE TABLETS FOR VERY LARGE DOGS
85413 - BRAVECTO PLUS FLEA, TICK AND WORM 500 MG FLURALANER AND 25 MG MOXIDECTIN SPOT-ON SOLUTION FOR LARGE CATS
87859 - BRAVECTO 1-MONTH 560 MG FLURALANER CHEWABLE TABLETS FOR VERY LARGE DOGS
92595 - BRAVECTO 1-MONTH COMBO 600 MG FLURALANER PLUS 45 MG MILBEMYCIN OXIME CHEWABLE TABLETS FOR VERY LARGE DOGS
Active constituents:
Active constituent name
80697 - FLURALANER
Active constituent name
85368 - MOXIDECTIN
Active constituent name
94930 - Pyrantel embonate
Description of data provided:
Data no
285055
Title
CEP moxidectin
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285056
Title
Monograph Moxidectin for Veterinary Use
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285057
Title
Moxidectin specification
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285058
Title
Moxidectin COA
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285059
Title
Pyrantel embonate CEP
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285060
Title
Pyrantel embonate monograph
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285061
Title
Pyrantel embonate specification
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285062
Title
Pyrantel embonate COA
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285063
Title
Fluralaner specification
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285065
Title
Fluralaner COA
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285072
Title
Moxidectin supplier statement 136172
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285087
Title
Analytical methods description 136176
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285088
Title
Analytical method validation report Doc-ID FMP-MV0088-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285089
Title
Analytical method validation report Doc-ID FMP-MV0089-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285090
Title
Analytical method validation report Doc-ID FMP-MV0090-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285091
Title
Analytical method validation report Doc-ID FMP-MV0091-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285092
Title
Analytical method validation report Doc-ID FMP-MV0086-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285093
Title
Analytical method validation report Doc-ID FMP-MV0087-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285094
Title
Analytical method validation report ref UEB2204155
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285095
Title
Analytical method validation report Doc-ID FMP-MV0092-VR-01
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285084
Title
Finished product COA
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285073
Title
Excipient supplier statement 137805
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285074
Title
Excipient virus safety assessment 138216
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285075
Title
Finished product TSE declaration
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285077
Title
VIE-07-132-SD process scheme
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285078
Title
Justification of specifications 136180
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285079
Title
Justification of specifications Document No. 135507
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285080
Title
Reference standard COA 136020
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285081
Title
Reference standard COA 136525
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285082
Title
Reference standard COA 136527
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285083
Title
Reference standard COA 137814
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285066
Title
Antioxidant COA
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285067
Title
MS ingredient COA
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285068
Title
Validation report document no 1087-2015-VR
Study date
2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285069
Title
MS excipient specification 097776
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285070
Title
MS excipient COA UIN144845
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285071
Title
Excipient product information 136172
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283442
Title
GMP 1
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283443
Title
GMP 2
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283444
Title
GMP 3
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283445
Title
GMP 4
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285052
Title
GMP evidence
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285053
Title
Pharmaceutical Development Report
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285054
Title
Packaging specification
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285064
Title
VIE-QRA-061 risk assessment report
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285076
Title
DAFF permit applciation 0009491890
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285096
Title
Part 2 overview
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285085
Title
Stability summary report 097948
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285086
Title
Stability data 094854
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290774
Title
Ivermectin 20 years on: maturation of a wonder drug.
Study date
2005
Auth party contact address
-
Data no
290775
Title
Toxicology of Avermectins and Milbemycins (Macrocyclic Lactones) and the Role of P-Glycoprotein in Dogs and Cats.
Study date
2012
Auth party contact address
-
Data no
290769
Title
CVMP Assessment Report for Bravecto TriUno
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290770
Title
PAA ID 137728 - APVMA written assistance
Study date
2023
Data no
290771
Title
APVMA cover letter
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290772
Title
APVMA Efficacy and Target Animal safety of Veterinary Medicines Risk Assessment Technical Report 139141
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290796
Title
Efficacy study S22151-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290797
Title
Efficacy study S20020-00
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290798
Title
Scientific advice, fluralaner-moxidectin-pyrantel. Document number 127938
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290799
Title
Efficacy of a new oral chewable tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio) against induced ascarid infections in dogs.
Study date
2020
Auth party contact address
-
Data no
290800
Title
Chapter 19.4.2 Strategic control of important parasitoses of dogs and cats, pp. 599-607. Chapter 20. Trade names of antiparasitics and vaccines, p. 615-617
Study date
2016
Auth party contact address
-
Data no
290801
Title
Efficacy study S22175-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290802
Title
Efficacy study S22174-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290803
Title
MSD AH response to s159, application no. 135982
Study date
2023
Data no
290804
Title
S159(1)(a) notice, application no. 135982
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290805
Title
Phylogenetic and phylogeographic relationships in Ixodes holocyclus and Ixodes cornuatus (Acari: Ixodidae) inferred from COX1 and ITS2 sequences.
Study date
2011
Auth party contact address
-
Data no
290806
Title
Efficacy and Target Animal safety of Veterinary Medicines Risk Assessment Technical Report, application no. 135982
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290807
Title
Efficacy study no. 22-061
Study date
2023
Data no
290808
Title
Efficacy study no. S22213-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290809
Title
Efficacy study no. S22207-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290810
Title
Efficacy study no. S20100-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290811
Title
Efficacy study no. S22081-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290812
Title
Efficacy study no. S20099-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290813
Title
Efficacy study no. S20097-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290814
Title
Efficacy study no. S20098-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290815
Title
Efficacy study no. S21216-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290816
Title
Efficacy study no. S22024-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290817
Title
Efficacy study no. S20025-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290818
Title
Efficacy study no. S22218-00
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290819
Title
CVMP assessment report for Credelio Plus
Study date
2021
Auth party contact address
-
Data no
290820
Title
CVMP assessment report for Nexgard Spectra
Study date
2014
Auth party contact address
-
Data no
290821
Title
Preventive efficacy of six monthly oral doses of Simparica Trio, Heartgard Plus, and Interceptor Plus against a macrocyclic lactone resistant strain (ZoeLA) of heartworm (Dirofilaria immitis) in dogs.
Study date
2022
Auth party contact address
-
Data no
290822
Title
Preventive efficacy of four or six monthly oral doses of 24 micrograms/kg moxidectin compared to six monthly doses of Heartgard Plus or Interceptor Plus against macrocyclic lactone resistant heartworm (Dirofilaria immitis) strains in dogs.
Study date
2020
Auth party contact address
-
Data no
290823
Title
Correspondence to APVMA regarding product no. 92595
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290824
Title
The 3Rs Concept. Time to Change How We Evaluate the Efficacy of Anthelmintics in Companion Animals
Study date
2018
Auth party contact address
-
Data no
290825
Title
World Association for the Advancement of Veterinary Parasitology (WAAVP) Second edition of guidelines for evaluating the efficacy of anthelmintics for dogs and cats
Study date
2022
Auth party contact address
-
Data no
290826
Title
Email advice regarding dose confirmation studies
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290827
Title
Efficacy study no. S20181-00
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290828
Title
Validation report no. 173896
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290829
Title
Efficacy study no. S20142-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290830
Title
Efficacy study no. S23071-00
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290831
Title
Efficacy study no. S22130-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290832
Title
Efficacy study no. S22150-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290833
Title
Efficacy study no. S20140-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290834
Title
Efficacy study no. S20141-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290835
Title
Efficacy study no. S21156-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290836
Title
Efficacy study no. S20163-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290837
Title
The Mini-FLOTAC technique for the diagnosis of helminth and protozoan infections in humans and animals.
Study date
2017
Auth party contact address
-
Data no
290838
Title
Differentiation of ova of Ancylostoma caninum and Uncinaria stenocephala in dogs.
Study date
1953
Auth party contact address
-
Data no
290839
Title
Efficacy, safety and palatability of a new broad-spectrum anthelmintic formulation in dogs.
Study date
2010
Auth party contact address
-
Data no
290840
Title
Efficacy of ivermectin and pyrantel pamoate combined in a chewable formulation against heartworm, hookworm and ascarid infections in dogs.
Study date
1992
Auth party contact address
-
Data no
290841
Title
Control of Toxocara canis in puppies: a comparison ot screening techniques and evaluation of a dosing programme.
Study date
1987
Auth party contact address
-
Data no
290842
Title
Effects of pyrantel pamoate on adult and preadult Toxocara canis worms: an electron microscope and autoradiography study.
Study date
1993
Auth party contact address
-
Data no
290843
Title
Efficacy study no. S22206-00
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290844
Title
Larval development of Toxocara canis in dogs.
Study date
2011
Auth party contact address
-
Data no
290845
Title
Recurrent patent infections with Toxocara canis in household dogs older than six months: a prospective study.
Study date
2016
Auth party contact address
-
Data no
290846
Title
VICH GL19 - Efficacy of anthelmintics: specific recommendations for canines, revision 1.
Study date
2022
Auth party contact address
-
Data no
290847
Title
Expert statament, document no. 133241
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290848
Title
Efficacy study S21130-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290849
Title
Efficacy study S21194-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290850
Title
Efficacy study S22156-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290851
Title
Additional analysis for validation report document no. 173896
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290852
Title
Efficacy study S22176-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290853
Title
Efficacy study S22177-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290854
Title
Efficacy study S20220-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290855
Title
Efficacy study S22012-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290856
Title
Efficacy study S22013-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290857
Title
Efficacy study S22008-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290858
Title
Efficacy study S22009-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290859
Title
Efficacy study S20164-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290860
Title
Efficacy study S22010-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290861
Title
Efficacy study S22011-00
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290862
Title
Efficacy study S16375-00
Study date
2018
Data no
290863
Title
Effects on the development of Dipylidium caninum and on the host reaction to this parasite in the adult flea (Ctenocephalides felis felis).
Study date
1987
Auth party contact address
-
Data no
290864
Title
Efficacy study 2018-GM-001
Study date
2018
Data no
290791
Title
Multiple drug resistance in the canine hookworm Ancylostoma caninum: an emerging threat?
Study date
2019
Auth party contact address
-
Data no
290792
Title
Multiple anthelmintic drug resistance in hookworms (Ancylostoma caninum) in a Labrador breeding and training kennel in Georgia, USA
Study date
2023
Auth party contact address
-
Data no
290793
Title
High-level pyrantel resistance in the hookworm Ancylostoma caninum.
Study date
2007
Auth party contact address
-
Data no
290794
Title
Pyrantel resistance in canine hookworms in Queensland, Australia.
Study date
2024
Auth party contact address
-
Data no
290872
Title
Efficacy study S20135-00
Study date
2022
Data no
290873
Title
Efficacy study S20136-00
Study date
2022
Data no
290874
Title
An additional laboratory study to support the efficacy studies
Study date
2022
Data no
290875
Title
Clinical validation of molecular markers of macrocyclic lactone resistance in Dirofilaria immitis.
Study date
2018
Auth party contact address
-
Data no
290876
Title
Macrocyclic lactone resistance in Dirofilaria immitis: risks for prevention of heartworm disease
Study date
2021
Auth party contact address
-
Data no
290877
Title
The Use of Molecular Markers to Investigate Possible Resistance to Heartworm Preventives in Dirofilaria Immitis Samples from Heartworm Positive Dogs in Europe
Study date
2021
Auth party contact address
-
Data no
290879
Title
Pharmacokinetics of fluralaner in dogs following a single oral or intravenous administration
Study date
2014
Auth party contact address
-
Data no
290880
Title
Estimation of absolute oral bioavailability of moxidectin in dogs using a semi-simultaneous method: influence of lipid co-administration.
Study date
2007
Auth party contact address
-
Data no
290881
Title
Pharmacokinetics and Dose Proportionality of Oral Moxidectin in Beagle Dogs
Study date
2002
Auth party contact address
-
Data no
290882
Title
Efficacy study S15312-01
Study date
2017
Data no
290884
Title
CVMP assessment report for Simparica Trio
Study date
2019
Auth party contact address
-
Data no
290885
Title
Simparica Trio US product insert
Study date
2022
Auth party contact address
-
Data no
290886
Title
Efficacy of oral moxidectin against susceptible and resistant isolates of Dirofilaria immitis in dogs
Study date
2017
Auth party contact address
-
Data no
290887
Title
FOI Summary, ProHeart
Study date
1997
Auth party contact address
-
Data no
290888
Title
Preventive efficacy of oral moxidectin at various doses and dosage regimens against macrocyclic lactone-resistant heartworm (Dirofilaria immitis) strains in dogs
Study date
2019
Auth party contact address
-
Data no
290889
Title
Laboratory and field studies to investigate the efficacy of a novel, orally administered combination product containing moxidectin, sarolaner and pyrantel for the prevention of heartworm disease (Dirofilaria immitis) in dogs
Study date
2019
Auth party contact address
-
Data no
290890
Title
Safety of moxidectin in avermectin-sensitive Collies.
Study date
2000
Auth party contact address
-
Data no
290891
Title
Concern for Dirofilaria immitis and Macrocyclic Lactone Loss of Efficacy: Current Situation in the USA and Europe, and Future Scenarios
Study date
2021
Auth party contact address
-
Data no
290892
Title
Moxidectin: heartworm disease prevention in dogs in the face of emerging macrocyclic lactone resistance
Study date
2022
Auth party contact address
-
Data no
290894
Title
Efficacy study no. S22023-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293247
Title
Efficacy study S24056-00
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
293249
Title
VICH GL7 (Anthelmintics General). Efficacy of Anthelmintics: General Requirements (Revision 1), November 2024.
Study date
2024
Auth party contact address
-
Data no
293248
Title
Part 8 Application Overview - final stage submission
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290893
Title
Part 8 Application Overview
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290867
Title
Acute Lung Injury Epidemiology, Pathogenesis, and Treatment.
Study date
2010
Auth party contact address
-
Data no
290868
Title
Development of a PCR-based diagnostic test detecting a nt230(del4) MDR1 mutation in dogs: verification in a moxidectin-sensitive Australian Shepherd
Study date
2005
Auth party contact address
-
Data no
290869
Title
Freedom of Information Summary, Simparica Trio
Study date
2020
Auth party contact address
-
Data no
290870
Title
Part 8 application overview, Item 25
Study date
2023
Data no
290871
Title
Pre-Application Assistance ID 137728, written assistance
Study date
2023
Data no
290795
Title
Document Number 135169. Justification of combination
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290883
Title
Pharmacokinetic study S20104-00
Study date
2021
Data no
290878
Title
Pharmacokinetic study S20029-00
Study date
2023
Data no
290773
Title
Pharmacological assessment report Document Number 128789
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290776
Title
Glutamate-gated Chloride Channels.
Study date
2012
Auth party contact address
-
Data no
290777
Title
Aspects of the pharmacology of a new anthelmintic: pyrantel.
Study date
1970
Auth party contact address
-
Data no
290778
Title
The action of pyrantel as an agonist and an open channel blocker at acetylcholine receptors in isolated Ascaris suum muscle vesicles.
Study date
1994
Auth party contact address
-
Data no
290779
Title
Diversity of vertebrate nicotinic acetylcholine receptors.
Study date
2009
Auth party contact address
-
Data no
290780
Title
Oxantel is an N-type (methyridine and nicotine) agonist not an L-type (levamisole and pyrantel) agonist: classification of cholinergic anthelmintics in Ascaris.
Study date
2004
Auth party contact address
-
Data no
290781
Title
Pyrantel Embonate Summary Report.
Study date
1998
Auth party contact address
-
Data no
290782
Title
WHO Model List of Essential Medicines, 22nd List.
Study date
2021
Auth party contact address
-
Data no
290783
Title
New GABA/Glutamate Receptor Target for 3H Isoxazoline Insecticide
Study date
2013
Auth party contact address
-
Data no
290784
Title
Insect gamma Aminobutyric Acid Receptors and Isoxazoline Insecticides: Toxicological Profiles Relative to the Binding Sites of 3H Fluralaner, 3H 4 Ethynyl 4n propylbicycloorthobenzoate and 3H Avermectin.
Study date
2014
Auth party contact address
-
Data no
290785
Title
Plasma pharmacokinetic profile of fluralaner (Bravecto) and ivermectin following concurrent administration to dogs.
Study date
2015
Auth party contact address
-
Data no
290787
Title
S20033-00 Pharmacokinetic Study
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290788
Title
Study V-0084x-0089 - metabolic stability
Study date
2009
Data no
290789
Title
Pharmacokinetic study V-0084-0126
Study date
2011
Data no
290790
Title
Plasma clearance
Study date
2004
Auth party contact address
-
Data no
290786
Title
S20193-00 Target Animal Safety Study
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290865
Title
Target animal safety study S20026-00
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290866
Title
Target animal safety study S19224-00
Study date
2021
Data no
283198
Title
Project Plan
Study date
19 Dec 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283207
Title
S16245-00 dermal tolerance study
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283199
Title
Application overview
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283201
Title
Pharmaceutical development report
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283202
Title
S20029-00 pharmacokinetic study
Study date
2023
Data no
283203
Title
Pharmacokinetics and Dose Proportionality of Oral Moxidectin in Beagle Dogs
Study date
2002
Auth party contact address
-
Data no
283204
Title
Estimation of absolute oral bioavailability of moxidectin in dogs using a semi-simultaneous method: influence of lipid co-administration
Study date
2007
Auth party contact address
-
Data no
283205
Title
CVMP assessment report doc no 130233
Study date
2019
Data no
283206
Title
PYRANTEL EMBONATE SUMMARY REPORT
Study date
1998
Auth party contact address
-
Data no
283213
Title
Health Hazard Criteria 1910
Study date
2013
Data no
283214
Title
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Study date
2019
Data no
283215
Title
S20193-00 target animal safety study (submitted via Objective Connect)
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283216
Title
S19224-00 Target Animal Safety Study
Study date
2021
Data no
283217
Title
S20026-00 Target Animal Safety Study
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283218
Title
Safety of moxidectin in avermectin-sensitive Collies
Study date
2000
Data no
283219
Title
Development of a PCR- based diagnostic test detecting a nt230(del4) MDR1 mutation in dogs: verification in a moxidectin-sensitive Australian Shepherd
Study date
2005
Auth party contact address
-
Data no
283220
Title
Freedom of Information Summary NADA 141-521 - Simparica Trio
Study date
2020
Auth party contact address
-
Data no
283221
Title
Summary advice EMA/SA/0000064418
Study date
2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283222
Title
Safety CER Doc. No. 097063
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283223
Title
User Risk Assessment
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283210
Title
Morantel Summary Report
Study date
2005
Auth party contact address
-
Data no
283211
Title
InfoCard for pyrantel
Study date
2022
Auth party contact address
-
Data no
283212
Title
Use and implications of the harmonic mean model on mixtures for basic research and drug discovery.
Study date
2011
Auth party contact address
-
Data no
283200
Title
Doc No. 128789 - expert report
Study date
2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283208
Title
S16243-00 toxicity study
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
283209
Title
S16244-00 toxicity study
Study date
2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
147626
Product/Active constituent Name
Application Product Name
Vetmedin 1.5 mg/mL Oral Solution for Dogs
Application Date
Application Number
147626
Application Product Name
Vetmedin 1.5 mg/mL Oral Solution for Dogs
Application details
Product name:
Vetmedin 1.5 mg/mL Oral Solution for Dogs
Product number:
95920
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of a 1.5 mg/mL pimodendan oral solution for the treatment of heart disease in dogs.
Reference details:
53561 - VETMEDIN 2.5 MG CAPSULES FOR DOGS
53562 - VETMEDIN 5 MG CAPSULES FOR DOGS
55523 - VETMEDIN 1.25 MG CAPSULES FOR DOGS
Active constituents:
Active constituent name
55315 - PIMOBENDAN
Description of data provided:
Data no
284260
Title
certificates of analysis - pimobendan
Study date
27/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284259
Title
pimobendan specifications
Study date
28/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284276
Title
Control strategy summary
Study date
13/02/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284277
Title
Justification of the specifications for the drug product
Study date
19/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284278
Title
Identity of pimobendan
Study date
27/03/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284279
Title
Assay and Identity of pimobendan
Study date
27/03/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284280
Title
validation of assay and identity of pimobendan
Study date
18/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284282
Title
Validation of Analytical Procedure for the Drug Product
Study date
21/02/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284283
Title
Analytical Procedure for the Drug Product
Study date
27/03/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284284
Title
Validation of Analytical Procedure for the Drug Product
Study date
19/02/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284285
Title
Analytical Procedure for the Drug Product
Study date
7/02/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284265
Title
Batch Analyses for the Drug Product - pilot
Study date
12/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284266
Title
Batch Analyses for the Drug Product - commercial
Study date
30/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284267
Title
Batch Analyses for the Drug Product - commercial (2)
Study date
13/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284268
Title
Certificates of analysis - pilot batches
Study date
11/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284269
Title
Certificates of analysis - commercial batches
Study date
20/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284270
Title
Certificates of analysis - commercial batches (2)
Study date
14/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284261
Title
excipient specifications and CoAs
Study date
18/12/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284262
Title
Description of Manufacturing Process and Process Controls
Study date
29/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284263
Title
Process Validation Report
Study date
11/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284264
Title
Specification for the Drug Product
Study date
12/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284255
Title
GMP certificates for the manufacturing sites
Study date
21/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284257
Title
Pharmaceutical Development
Study date
19/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284258
Title
Description and Composition of the Drug Product
Study date
15/12/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284281
Title
Analytical Procedure for the Drug Product
Study date
27/03/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284301
Title
Excipient safety reivew
Study date
20/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284256
Title
Critical expert report on the quality documentation
Study date
10/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284286
Title
Description of the Container Closure System
Study date
31/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284287
Title
Packaging Procedure
Study date
15/12/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284288
Title
cap plug-in
Study date
07/02/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284289
Title
cap and teflon liner
Study date
30/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284290
Title
glass bottle
Study date
30/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284291
Title
syringe barrel
Study date
30/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284292
Title
syringe plunger
Study date
30/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284271
Title
Stability data - pilot batches
Study date
27/05/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284272
Title
Stability data - commercial batches
Study date
14/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284273
Title
In use stability studies
Study date
28/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284274
Title
Photostability studies
Study date
05/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284275
Title
Stability Summary and Conclusions
Study date
16/12/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284293
Title
CRITICAL EXPERT REPORT ON THE EFFICACY DOCUMENTATION
Study date
16/05/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284302
Title
B-cyclodextrin: 52 week toxicity studies in the rat and dog
Study date
1995
Auth party contact address
-
Data no
284303
Title
Cyclodextrins used as excipients
Study date
2017
Auth party contact address
-
Data no
284304
Title
beta-cyclodextrin
Study date
2023
Auth party contact address
-
Data no
284305
Title
Comprehensive investigation of alternative formulation vehicles
Study date
2010
Auth party contact address
-
Data no
284306
Title
Scientific Opinion on the safety and efficacy of sorbic acid and potassium sorbate
Study date
2014
Auth party contact address
-
Data no
284307
Title
Opinion on the follow up re-evaluation of sorbic acid and potassium sorbate
Study date
2019
Auth party contact address
-
Data no
284308
Title
Substances generally recognized as safe - chemical preservatives
Study date
31/3/2023
Auth party contact address
-
Data no
284299
Title
Clinical trial formulations and batches
Study date
24/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284300
Title
CRITICAL EXPERT REPORT ON THE SAFETY DOCUMENTATION
Study date
16/05/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284294
Title
Bioequivalence report - part 1
Study date
06/10/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284295
Title
Bioequivalence report - part 2
Study date
06/10/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284296
Title
Bioequivalence report - part 3
Study date
06/10/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284297
Title
Bioequivalence report - part 4
Study date
06/10/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284298
Title
Bioequivalence report - part 5
Study date
06/10/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284254
Title
Executive summary - chemistry and manufacture
Study date
27/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284309
Title
Executive summary - safety and efficacy
Study date
27/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287015
Title
Handbook of Pharmaceutical Excipients
Study date
2009
Auth party contact address
-
Data no
287016
Title
User Risk Assessment
Study date
20/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287017
Title
Excipient 1 SDS
Study date
03/01/2016
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287018
Title
Excipient 2 SDS
Study date
24/04/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287019
Title
Excipient 3 SDS
Study date
02/11/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287020
Title
Excipient 4 SDS
Study date
2/12/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287021
Title
response to 2159 notice
Study date
27/05/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147321
Product/Active constituent Name
Application Product Name
Bio Blaster Herbicide
Application Date
Application Number
147321
Application Product Name
Bio Blaster Herbicide
Application details
Product name:
Bio Blaster Herbicide
Product number:
95836
Applicant Name:
CERTIFIED ORGANICS (AUST.) PTY LIMITED
Application purpose and description of use:
Registration of a 680 g/L pine oil soluble concentrate product for the non-selective control of seedling weeds and grasses and for the suppression of established weeds.
Reference details:
62367 - BIOWEED ORGANIC HERBICIDE CONCENTRATE
Date
Application Date
Application No
Application Number
147566
Product/Active constituent Name
Application Product Name
Agro-Essence Azoxystrobin & Cyproconazole 280 SC Fungicide
Application Date
Application Number
147566
Application Product Name
Agro-Essence Azoxystrobin & Cyproconazole 280 SC Fungicide
Application details
Product name:
Agro-Essence Azoxystrobin & Cyproconazole 280 SC Fungicide
Product number:
95904
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 200 g/L Azoxystrobin and 80 g/L Cyproconazole suspension concentrate (SC) for the control of certain fungal diseases in Barley, Wheat and Peanuts
Reference details:
88169 - AC Amazer 280 Fungicide
Active constituents:
Active constituent name
67359 - AZOXYSTROBIN
Active constituent name
68119 - CYPROCONAZOLE
Date
Application Date
Application No
Application Number
147391
Product/Active constituent Name
Application Product Name
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Large Dogs
Application Date
Application Number
147391
Application Product Name
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Large Dogs
Application details
Product name:
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Large Dogs
Product number:
95861
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 400 mg fluralaner, 200 mg pyrantel and 1.0 mg moxidectin chewable tablet for the control of fleas, ticks, heartworm and internal parasites of dogs.
Reference details:
68873 - BRAVECTO 1400 MG FLURALANER CHEWABLE TABLETS FOR VERY LARGE DOGS
85413 - BRAVECTO PLUS FLEA, TICK AND WORM 500 MG FLURALANER AND 25 MG MOXIDECTIN SPOT-ON SOLUTION FOR LARGE CATS
87859 - BRAVECTO 1-MONTH 560 MG FLURALANER CHEWABLE TABLETS FOR VERY LARGE DOGS
92595 - BRAVECTO 1-MONTH COMBO 600 MG FLURALANER PLUS 45 MG MILBEMYCIN OXIME CHEWABLE TABLETS FOR VERY LARGE DOGS
Active constituents:
Active constituent name
80697 - FLURALANER
Active constituent name
85368 - MOXIDECTIN
Active constituent name
94930 - Pyrantel embonate
Date
Application Date
Application No
Application Number
147395
Product/Active constituent Name
Application Product Name
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Medium Dogs
Application Date
Application Number
147395
Application Product Name
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Medium Dogs
Application details
Product name:
BRAVECTO 1-MONTH TRIPLE Chewable Tablets for Medium Dogs
Product number:
95864
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 200 mg fluralaner, 100 mg pyrantel and 0.5 mg moxidectin chewable tablet for the control of fleas, ticks, heartworm and internal parasites of dogs.
Reference details:
68873 - BRAVECTO 1400 MG FLURALANER CHEWABLE TABLETS FOR VERY LARGE DOGS
85413 - BRAVECTO PLUS FLEA, TICK AND WORM 500 MG FLURALANER AND 25 MG MOXIDECTIN SPOT-ON SOLUTION FOR LARGE CATS
87859 - BRAVECTO 1-MONTH 560 MG FLURALANER CHEWABLE TABLETS FOR VERY LARGE DOGS
92595 - BRAVECTO 1-MONTH COMBO 600 MG FLURALANER PLUS 45 MG MILBEMYCIN OXIME CHEWABLE TABLETS FOR VERY LARGE DOGS
Active constituents:
Active constituent name
80697 - FLURALANER
Active constituent name
85368 - MOXIDECTIN
Active constituent name
94930 - Pyrantel embonate
Date
Application Date
Application No
Application Number
147389
Product/Active constituent Name
Application Product Name
Velum Prime Nematicide
Application Date
Application Number
147389
Application Product Name
Velum Prime Nematicide
Application details
Product name:
Velum Prime Nematicide
Product number:
94142
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Variation of label approval to add additional uses in bananas and ginger.
Active constituents:
Active constituent name
63735 - FLUOPYRAM
Active constituent name
90823 - Fluopyram
Description of data provided:
Data no
283976
Title
Registration of Velum Prime Nematicide for control of nematodes in banana and ginger.
Study date
6 February 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283977
Title
Evaluation of nematicide in banana.
Study date
12 January 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283978
Title
Evaluation of nematicide in banana.
Study date
30 January 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283979
Title
Evaluation of insecticide for nematode control in bananas.
Study date
17 June 2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283980
Title
Evaluation of insecticide in bananas.
Study date
17 June 2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283981
Title
Evaluation of an insecticide in bananas.
Study date
03 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283982
Title
Evaluation of an insecticide in bananas.
Study date
03 January 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283983
Title
Evaluation of nematicide in banana.
Study date
6 January 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283984
Title
Evaluation of the efficacy and crop safety of Velum 400 SC Nematicide (fluopyram) for the control of root knot nematode in ginger.
Study date
21 January 2022
Auth party contact address
21 Rosella Ave., Strathfieldsaye, Victoria, 3551
Data no
283985
Title
Evaluation of the efficacy and crop safety of Velum 400 SC Nematicide (fluopyram) for the control of root knot nematode in ginger.
Study date
24 January 2022
Auth party contact address
21 Rosella Ave., Strathfieldsaye, Victoria, 3551
Data no
283986
Title
Velum Prime Nematicide draft label.
Study date
6 February 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283969
Title
Label extension into ginger.
Study date
5 February 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294375
Title
Notice of decision - Luna Experience Fungicide - Finalisation letter for item 25 application. M-885827-01-1
Study date
2025-06-17
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283972
Title
Residues and trade evaluation report.
Study date
February 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283973
Title
Determination of residues of fluopyram in ginger when applied at planting and at post-emergence.
Study date
17 January 2024
Auth party contact address
21 Rosella Ave., Strathfieldsaye, Victoria, 3551
Data no
283974
Title
Determination of residues of fluopyram in bananas following applications of Fluopyram 400 SC.
Study date
26 March 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283975
Title
Determination of residues of fluopyram in bananas following applications of Fluopyram 400 SC and Luna Experience SC.
Study date
6 January 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294369
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop corn after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in the Netherlands, Germany, southern France and Spain. M-757940-03-1
Study date
2022-07-24
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294370
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop wheat and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Spain and southern France. M-764452-02-1
Study date
2022-09-22
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294371
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop rape and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in the Netherlands, Belgium, southern France and Spain. M-764453-02-2
Study date
2022-07-28
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294372
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop pea and soil after spray application of BCS-CS55621 SC 020 and fluopyram SC 250 to bare soil in Belgium, Germany, southern France and Spain - amendment no. 1 to final report. M-764456-02-1
Study date
2022-06-21
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294373
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop spring wheat and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Germany and northern France. M-766647-03-1
Study date
2023-09-06
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294374
Title
Determination of fluopyram in plant back crops following the application of a fluopyram containing product to bare earth several months prior to planting. M-841479-01-1
Study date
2022-06-27
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294376
Title
Risk assessment capability - Residues and trade evaluation report - Luna Experience Fungicide. M-885826-01-1
Study date
2025-05-30
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
294377
Title
Part 5 Residues: fluopyram and tebuconazole in various crops (amended). M-886013-01-1
Study date
2024-06-27
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283970
Title
Part 5 - Residues: fluopyram in bananas and ginger.
Study date
6 February 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283971
Title
Velum Prime Nematicide draft label.
Study date
6 February 2025
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia