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
147625
Product/Active constituent Name
Application Product Name
coumatetralyl
Application Date
Application Number
147625
Application Product Name
coumatetralyl
Application details
Product name:
coumatetralyl
Active name:
coumatetralyl
Applicant Name:
HELIDON TECH PTY LTD
Application purpose and description of use:
Approval of coumatetralyl for use in agricultural chemical products.
Description of data provided:
Data no
284383
Title
Analytical method for coumatetralyl assay in coumatetralyl TGAC with method validation report by HPLC
Study date
30/06/2001
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Data no
284384
Title
Coumatetralyl technical
Study date
1994
Auth party contact address
-
Data no
284381
Title
Summary of 5-batch results
Study date
16/12/2024
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Data no
284382
Title
Analytical Department Statement
Study date
16/12/2024
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Data no
284380
Title
Coumatetralyl ??? Manufacturing Process
Study date
21/04/2002
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Data no
284385
Title
Quality specification for coumatetralyl technical grade
Study date
02/04/2005
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Data no
284386
Title
Part 2 Summary
Study date
February 2025
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Data no
284379
Title
Notice of approval of active constituent
Study date
23/04/2022
Auth party contact address
3 TAHLEE CLOSE CASTLE HILL Australia
Date
Application Date
Application No
Application Number
147675
Product/Active constituent Name
Application Product Name
Quantum 2,4-D 500 SL Herbicide
Application Date
Application Number
147675
Application Product Name
Quantum 2,4-D 500 SL Herbicide
Application details
Product name:
Quantum 2,4-D 500 SL Herbicide
Product number:
95951
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 500g/L 2,4-DB present as the dimethylamine salt soluble concentrate (SL) product for the control of broadleaf weeds in seedling and established Lucerne, medic and clover pastures, peanuts and cereal crops undersown with Lucerne, medic or clover as specified in the Directions for Use table.
THIS IS A PHENOXY HERBICIDE THAT CAN CAUSE SEVERE DAMAGE TO NATIVE VEGETATION AND SUSCEPTIBLE CROPS SUCH AS COTTON, GRAPES, TOMATOES, OILSEED CROPS AND ORNAMENTALS.
Reference details:
87501 - F.S.A. 24DB Herbicide
Active constituents:
Active constituent name
68528 - 2,4-DB
Date
Application Date
Application No
Application Number
147827
Product/Active constituent Name
Application Product Name
Saflufenacil
Application Date
Application Number
147827
Application Product Name
Saflufenacil
Application details
Product name:
Saflufenacil
Active name:
Saflufenacil
Applicant Name:
GREENCHEM HK LTD
Application purpose and description of use:
Approval of Saflufenacil TGAC for use in agricultural chemical products.
Description of data provided:
Data no
284449
Title
Five Batch Analysis of Saflufenacil Technical
Study date
19/12/2024
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
284452
Title
Certificate of Analysis
Study date
30/05/2024
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
284450
Title
Synthesis and Impurities of Saflufenacil Technical
Study date
2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
284451
Title
Declaration of Composition
Study date
04/03/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Date
Application Date
Application No
Application Number
147892
Product/Active constituent Name
Application Product Name
TOPSPIN POUR-ON FOR SHEEP
Application Date
Application Number
147892
Application Product Name
TOPSPIN POUR-ON FOR SHEEP
Application details
Product name:
TOPSPIN POUR-ON FOR SHEEP
Product number:
96006
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
Registration of a 20 g/L spinosad pour-on product for the control of spinosad-susceptible lice in sheep up to 7 days off-shears and sheep with long wool.
Reference details:
60117 - ELANCO AH0493 EXTINOSAD POUR-ON FOR SHEEP
Active constituents:
Active constituent name
89208 - SPINOSAD
Active constituent name
93061 - Spinosad
Description of data provided:
Data no
284540
Title
Product specifications
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
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
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
Unit 209 210 Reynolds Rd DONCASTER EAST Australia
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
Unit 209 210 Reynolds Rd DONCASTER EAST 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
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
147640
Product/Active constituent Name
Application Product Name
QUANTUM Bromoxynil-DFF EC HERBICIDE
Application Date
Application Number
147640
Application Product Name
QUANTUM Bromoxynil-DFF EC HERBICIDE
Application details
Product name:
QUANTUM Bromoxynil-DFF EC HERBICIDE
Product number:
95930
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 250 g/L Bromoxynil present as the octanoate and 25 g/L Diflufenican, as an emulsifiable Concentrate product as a specially formulated low volatile herbicide For control of certain broadleaf weeds in winter cereals and pasture as specified in the Directions For Use Table.
Reference details:
69269 - SABAKEM RECKON-B 275EC HERBICIDE
Active constituents:
Active constituent name
88239 - BROMOXYNIL OCTANOATE
Active constituent name
80658 - Diflufenican
Active constituent name
94247 - Diflufenican
Active constituent name
91221 - Diflufenican
Active constituent name
94444 - Diflufenican
Description of data provided:
Data no
284535
Title
Executive Summary
Study date
February 2025
Auth party contact address
Unit 209 210 Reynolds Rd DONCASTER EAST Australia
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
Unit 209 210 Reynolds Rd DONCASTER EAST 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
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
147378
Product/Active constituent Name
Application Product Name
FLURALANER 600 MG PLUS MOXIDECTIN 1.5 MG PLUS PYRANTEL EMBONATE 300 MG MONTHLY CHEWABLE TABLETS FOR VERY LARGE DOGS
Application Date
Application Number
147378
Application Product Name
FLURALANER 600 MG PLUS MOXIDECTIN 1.5 MG PLUS PYRANTEL EMBONATE 300 MG MONTHLY CHEWABLE TABLETS FOR VERY LARGE DOGS
Application details
Product name:
FLURALANER 600 MG PLUS MOXIDECTIN 1.5 MG PLUS PYRANTEL EMBONATE 300 MG MONTHLY CHEWABLE TABLETS FOR VERY LARGE DOGS
Product number:
95857
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 125 g/kg fluralaner plus 0.3125 g/kg moxidectin plus 62.5 g/kg pyrantel 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
283442
Title
GMP 1
Study date
2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283443
Title
GMP 2
Study date
2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283444
Title
GMP 3
Study date
2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283445
Title
GMP 4
Study date
2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283198
Title
Project Plan
Study date
19 Dec 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283207
Title
S16245-00 dermal tolerance study
Study date
2018
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283199
Title
Application overview
Study date
Feb 2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283201
Title
Pharmaceutical development report
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST 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
91-105 Harpin Street BENDIGO EAST 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
91-105 Harpin Street BENDIGO EAST 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
91-105 Harpin Street BENDIGO EAST Australia
Data no
283222
Title
Safety CER Doc. No. 097063
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283223
Title
User Risk Assessment
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST 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
91-105 Harpin Street BENDIGO EAST Australia
Data no
283208
Title
S16243-00 toxicity study
Study date
2018
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283209
Title
S16244-00 toxicity study
Study date
2018
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
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
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
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
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
284353
Title
NS240148001 (part 1)
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
284355
Title
NS240148002 (part 1)
Study date
February 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
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
284358
Title
NS240159001 (part 2)
Study date
February 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
284360
Title
NS240164009 (part2)
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
284362
Title
NS250009001 (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
284352
Title
Declaration of composition
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
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
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
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
284301
Title
Excipient safety reivew
Study date
20/01/2025
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
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
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
284254
Title
Executive summary - chemistry and manufacture
Study date
27/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia