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

145037
Product/Active constituent Name

Application Product Name

MCPB

Application details

Product name:

MCPB

Active name:

MCPB

Applicant Name:

Thai Harvest Limited

Application purpose and description of use:

Approval of MCPB Active Constituent for use in agricultural chemical products.

Description of data provided:

Data no
276601
Author
Yeming Zhang
Title
Qualitative and Quantitative Profile of MCPB Technical (Five batch Analysis)
Study date
July 12, 2024
Authorising party
Applicant
Auth party contact address
RMG, BLK 4, 13/F Kwun Tong Industrial Center Kwun Tong Road KwunTong KLN Hong Kong
Data no
276602
Author
Anon
Title
The synthesis process and impurities formation of MCPB
Study date
July 4, 2024
Authorising party
Applicant
Auth party contact address
RMG, BLK 4, 13/F Kwun Tong Industrial Center Kwun Tong Road KwunTong KLN Hong Kong
Data no
276603
Author
Andy Liu
Title
Declaration of Composition of MCPB
Study date
July 16, 2024
Authorising party
Applicant
Auth party contact address
RMG, BLK 4, 13/F Kwun Tong Industrial Center Kwun Tong Road KwunTong KLN Hong Kong
Date

Application Date

Application No

Application Number

144977
Product/Active constituent Name

Application Product Name

4Farmers Dalapon 740 Herbicide

Application details

Product name:

4Farmers Dalapon 740 Herbicide

Product number:

95207

Applicant Name:

4 FARMERS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 740 g/kg 2,2 DPA present the sodium salt water soluble powder product for the control of annual and perennial grasses including Couch, Kikuyu, Paspalum, Johnson, Cumbungi (Miranda Weed), and Rushes as per Directions for Use

Reference details:

59821 - DALAPON 740 SP SYSTEMIC GRASSKILLER

Active constituents:

Active constituent name
53108 - DALAPON-SODIUM
Date

Application Date

Application No

Application Number

144739
Product/Active constituent Name

Application Product Name

COXIDOX 50 COCCIDIOCIDE FOR PIGLETS AND CATTLE

Application details

Product name:

COXIDOX 50 COCCIDIOCIDE FOR PIGLETS AND CATTLE

Applicant Name:

DOX-AL AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 50g/L TOLTRAZURIL oral solution product for the control of coccidiosis in neonatal piglets caused by Isospora suis, and in cattle up to 9 months of age caused by Eimeria bovis or Eimeria zuernii. Indication. COXIDOX 50 is effective in one dose because it attacks all stages of the parasite in the animal. Piglets: COXIDOX 50 controls coccidiosis caused by Isospora suis infection of young piglets. Isospora suis infection is major cause of diarrhoea, dehydration, loss of appetite, poor growth, and occasional mortality in piglets between birth and 3-4 weeks of age. Cattle: COXIDOX 50 is for the treatment of clinical coccidiosis, and as an aid in the prevention of coccidiosis in the cattle up to 9 months of age. COXIDOX 50 controls coccidiosis caused by Eimeria bovis and Eimeria zuernii in young cattle. Coccidiosis typically occurs in cattle less than a year old causing diarrhoea wh
Date

Application Date

Application No

Application Number

145067
Product/Active constituent Name

Application Product Name

FLUXIMINE PASTE

Application details

Product name:

FLUXIMINE PASTE

Product number:

59238

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

Variation of label approval to harmonise the label between Australia and New Zealand.

Active constituents:

Active constituent name
84321 - FLUNIXIN MEGLUMINE

Description of data provided:

Data no
276625
Author
Not identified
Title
Fluximine Paste Manufacturer's declaration
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
276624
Author
McClure MR
Title
Fluximine Paste: Update Dosage
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Date

Application Date

Application No

Application Number

144998
Product/Active constituent Name

Application Product Name

Metacoxx Oral Suspension for Dogs

Application details

Product name:

Metacoxx Oral Suspension for Dogs

Product number:

63637

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

Variation of label approval to reword indication.

Reference details:

60023 - ILIUM MELOXICAM ANTI-INFLAMMATORY ORAL SUSPENSION FOR DOGS
Date

Application Date

Application No

Application Number

145061
Product/Active constituent Name

Application Product Name

Prosulfocarb

Application details

Product name:

Prosulfocarb

Active name:

Prosulfocarb

Applicant Name:

HEILONGJIANG KAILUNDA HIGH-TECH CO.,LTD.

Application purpose and description of use:

Approval of prosulfocarb for use in agricultural chemical products.

Description of data provided:

Data no
276679
Author
D Godden
Title
5-Batch Analysis of Prosulfocarb TGAI in Accordance with International Regulatory Requirements
Study date
May 2023
Authorising party
Applicant
Auth party contact address
Fine Chemical Industry Park Wanbaoshan Town Anda City, Suihua City Heilongjiang China
Data no
276680
Author
Anon
Title
Manufacturing process prosulfocarb technical
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Fine Chemical Industry Park Wanbaoshan Town Anda City, Suihua City Heilongjiang China
Data no
276681
Author
C Niu
Title
Declaration of composition
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Fine Chemical Industry Park Wanbaoshan Town Anda City, Suihua City Heilongjiang China
Data no
276682
Author
Anon
Title
Pack size and container declaration
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Fine Chemical Industry Park Wanbaoshan Town Anda City, Suihua City Heilongjiang China
Date

Application Date

Application No

Application Number

145108
Product/Active constituent Name

Application Product Name

POTASSIUM CLAVULANATE AND AMOXICILLIN TRIHYDRATE BLEND (1:1)

Application details

Product name:

POTASSIUM CLAVULANATE AND AMOXICILLIN TRIHYDRATE BLEND (1:1)

Active name:

POTASSIUM CLAVULANATE AND AMOXICILLIN TRIHYDRATE BLEND (1:1)

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of active source for use in veterinary chemical products.

Description of data provided:

Data no
276737
Author
Anon
Title
Specification
Study date
August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276738
Author
Anon
Title
Certificate of Analysis
Study date
June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

143952
Product/Active constituent Name

Application Product Name

Pentobarbital sodium

Application details

Product name:

Pentobarbital sodium

Active name:

Pentobarbital sodium

Applicant Name:

PROBUS PHARMACEUTICALS PTY LTD

Application purpose and description of use:

New source of pharmacopoeia active constituent

Description of data provided:

Data no
271501
Author
Anon
Title
CAM 01 COA
Study date
2023
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271502
Author
Anon
Title
CAM02: Work Flow
Study date
2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271504
Author
Anon
Title
Active Review
Study date
2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271503
Author
Anon
Title
CAM 03: Product Composition, Analysis and Quality Control
Study date
2024
Authorising party
Applicant
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date

Application Date

Application No

Application Number

145060
Product/Active constituent Name

Application Product Name

MAC Quizalofop-p-ethyl 100 Herbicide

Application details

Product name:

MAC Quizalofop-p-ethyl 100 Herbicide

Product number:

95239

Applicant Name:

MEENAKSHI AGRO CHEMICALS

Application purpose and description of use:

Registration of a 99.5 g/L quizalofop-p-ethyl 100 Herbicide Emulsifiable Concentrate product for the control of certain grass weeds in broadleaf crops

Reference details:

62712 - TARGA HERBICIDE

Active constituents:

Active constituent name
64503 - QUIZALOFOP-P-ETHYL
Date

Application Date

Application No

Application Number

144779
Product/Active constituent Name

Application Product Name

Sabakem Sabacor 350WG Insecticide

Application details

Product name:

Sabakem Sabacor 350WG Insecticide

Product number:

95137

Applicant Name:

SABAKEM PTY LTD

Application purpose and description of use:

Registration of a 350g/kg Chlorantraniliprole Water Dispersible Granule (WG) Insecticide product for the the Control of Lepidopteran species of insect pests in Cotton and Pulse crops, and Pome and Stone fruits as per the Directions for Use.

Reference details:

89266 - EuroChem CHARISMA Insecticide

Active constituents:

Active constituent name
84500 - Chlorantraniliprole
Active constituent name
86178 - CHLORANTRANILIPROLE

Description of data provided:

Data no
275516
Author
Eurochem Pty Ltd
Title
Consent for use of Confidential Commercial Information
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date

Application Date

Application No

Application Number

145033
Product/Active constituent Name

Application Product Name

Xtragro Copper-Micro Fungicide

Application details

Product name:

Xtragro Copper-Micro Fungicide

Product number:

95227

Applicant Name:

XTRAGRO PTY LTD

Application purpose and description of use:

Registration of a 93 g/L COPPER (Cu) present as COPPER AMMONIUM ACETATE COMPLEX soluble liquid product for the control of various diseases of fruit and vegetables.

Reference details:

63940 - COP-IT FUNGICIDE

Description of data provided:

Data no
276675
Author
B Defoort
Title
Manufacturer's declaration for Xtragro Copper-Micro Fungicide
Study date
31/07/2024
Authorising party
Applicant
Auth party contact address
1 Bowden Cresent Connells Point Australia
Date

Application Date

Application No

Application Number

145040
Product/Active constituent Name

Application Product Name

MAC Thiram 600 Fungicide

Application details

Product name:

MAC Thiram 600 Fungicide

Product number:

95232

Applicant Name:

MEENAKSHI AGRO CHEMICALS

Application purpose and description of use:

Registration of a 600 g/L THIRAM suspension concentrate product for the control of fungal diseases of turf and seed treatment.

Reference details:

67545 - GENFARM THIRAM 600 FUNGICIDE

Active constituents:

Active constituent name
53374 - THIRAM
Date

Application Date

Application No

Application Number

145038
Product/Active constituent Name

Application Product Name

MAC Deltamethrin 27.5 Insecticide

Application details

Product name:

MAC Deltamethrin 27.5 Insecticide

Product number:

95230

Applicant Name:

MEENAKSHI AGRO CHEMICALS

Application purpose and description of use:

Registration of a 27.5 g/L deltamethrin emulsifiable concentrate product for the control of Heliothis (Helicoverpa spp.) and other specified pests in cotton and various other crops

Reference details:

67007 - APPARENT DELTAMETHRIN DUO INSECTICIDE

Active constituents:

Active constituent name
44443 - DELTAMETHRIN
Date

Application Date

Application No

Application Number

145039
Product/Active constituent Name

Application Product Name

MAC Pyriproxyfen 100 Insect Growth Regulator

Application details

Product name:

MAC Pyriproxyfen 100 Insect Growth Regulator

Product number:

95231

Applicant Name:

MEENAKSHI AGRO CHEMICALS

Application purpose and description of use:

Registration of 100 g/L pyriproxyfen Emulsifiable concentrate product for the control of silverleaf whitefly (Bemisia tabaci Biotype B) in cotton, rockmelon and capsicum, the control of silverleaf whitefly (Bemisia tabaci Biotype B) and greenhouse whitefly in tomatoes, 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

145059
Product/Active constituent Name

Application Product Name

MAC METALAXYL M-350 ES SEED TREATMENT FUNGICIDE

Application details

Product name:

MAC METALAXYL M-350 ES SEED TREATMENT FUNGICIDE

Product number:

95238

Applicant Name:

MEENAKSHI AGRO CHEMICALS

Application purpose and description of use:

Registration of a 350 g/L metalaxyl-m emulsifiable suspension product for the control of seedling disease caused by Pythium and phytopthora in cotton, peas, lucerne, subterranean clover, carrots, beetroot, maize, sweetcorn and radish

Reference details:

84298 - 4Farmers Metalaxyl-M 350 Fungicide Seed Treatment

Active constituents:

Active constituent name
69603 - METALAXYL-M
Date

Application Date

Application No

Application Number

144765
Product/Active constituent Name

Application Product Name

Keyrole Insecticide

Application details

Product name:

Keyrole Insecticide

Product number:

95130

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

500 g/kg Clothianidin water dispersible granule formulation for the control of mealybug, woolly aphid and codling moth in apples and pears; green peach aphid and oriental fruit moth in peaches and nectarines; mealybug in grapes; Queensland and Mediterranean Fruit Fly in table grapes, persimmon, pome fruit and stone fruit; gall wasp, leaf miner, fullers rose weevil and California red scale in citrus and the control of African black beetle in turf.

Reference details:

60687 - SUMITOMO SAMURAI SYSTEMIC INSECTICIDE
60688 - SUMITOMO STEALTH SYSTEMIC INSECTICIDE

Active constituents:

Active constituent name
70306 - CLOTHIANIDIN

Description of data provided:

Data no
274801
Author
Anon
Title
Raws Specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274802
Author
anon
Title
Manufucturing method, Specs, CoA
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274800
Author
Yasser Sokeirik
Title
Chemistry Dossier
Study date
09/07/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274803
Author
Wang Youxin
Title
Accelerated Storage Stability Study on Clothianidin 50% WG-1
Study date
September 20, 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274804
Author
Wang Youxin
Title
Accelerated Storage Stability Study on Clothianidin 50% WG-2
Study date
September 20, 2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274805
Author
Anon
Title
METHOD VALIDATION
Study date
2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274813
Author
Shane Harvey
Title
Evaluation of a range of insecticides for pest control in Grapevines.
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274814
Author
Shane Harvey
Title
Evaluation f a range of insecticides for Codling Moth (Cydia Pomonella) and Woolly Aphid (Eriosma lanigerum) pest control in Apples.
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274815
Author
Anon
Title
Evaluation of Rainbow Keyrole 500WG insecticide for bioequivalence with Stealth Insecticide for control of African Black Beetle (Heteronychus arator) in Turf.
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274807
Author
Shandong Rainbow International
Title
Part 8: Efficacy and Crop Safety Dossier
Study date
12/07/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274806
Author
Anon
Title
Excutive Summary
Study date
12/07/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274808
Author
Anon
Title
Label of Keyrole
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
274809
Author
Anon
Title
Refernce product label 1
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
274810
Author
Anon
Title
Refernce product label 2
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
274811
Author
Anon
Title
Keyrole SDS
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
274812
Author
Anon
Title
Samurai Sye=stemic Insecticide SDS
Study date
2024
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

144864
Product/Active constituent Name

Application Product Name

CRYPTO-STOP ORAL SOLUTION FOR CALVES

Application details

Product name:

CRYPTO-STOP ORAL SOLUTION FOR CALVES

Product number:

95178

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

Registration of Crypto-stop oral solution for calves containing 0.5 g/L Halofuginone base (as the lactate) for control and prevention of diarrhoea caused by Cryptosporidium parvum in calves.

Reference details:

57163 - HALOCUR ORAL SOLUTION FOR TREATMENT OF CALVES

Active constituents:

Active constituent name
95179 - Halofuginone base (as lactate)

Description of data provided:

Data no
275771
Author
Abbey Laboratories Pty Ltd
Title
Product specificationsV1JUL24
Study date
Jul24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

144865
Product/Active constituent Name

Application Product Name

Halofuginone base (as lactate)

Application details

Product name:

Halofuginone base (as lactate)

Active name:

Halofuginone base (as lactate)

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

New source of active constituent.

Description of data provided:

Data no
276622
Author
Abbey Laboratories Pty Ltd
Title
Active chemistry dossier
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

144532
Product/Active constituent Name

Application Product Name

VETORYL 20 MG CAPSULES

Application details

Product name:

VETORYL 20 MG CAPSULES

Product number:

95041

Applicant Name:

DECHRA LTD

Application purpose and description of use:

Registration of a 20 mg trilostane oral capsule product for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing's disease and syndrome) in dogs.

Reference details:

64707 - VETORYL 10 MG CAPSULES
60620 - VETORYL 30 MG CAPSULES
60619 - VETORYL 60 MG CAPSULES
60618 - VETORYL 120 MG CAPSULES

Active constituents:

Active constituent name
86002 - TRILOSTANE

Description of data provided:

Data no
273594
Author
Anon
Title
Active CoA1
Study date
2022
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273595
Author
Anon
Title
Active CoA 2
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273596
Author
Anon
Title
Active CoA 3
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273597
Author
Anon
Title
Active CoA 4
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273598
Author
Anon
Title
Active CoA 5
Study date
2022
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273599
Author
Anon
Title
Active CoA 6
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273602
Author
Dechra
Title
Raw Material Specification
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273605
Author
Dechra
Title
Process Flowchart
Study date
2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273612
Author
Dechra
Title
Test Methods
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273608
Author
Dechra
Title
Finished Product CoA
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273606
Author
Dechra
Title
Process Validation Report
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273607
Author
Dechra
Title
Bulk Hold Report
Study date
2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273600
Author
Anon
Title
Manufacturer GMP Certificate
Study date
2022
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273601
Author
Dechra
Title
Vetoryl 20mg Hard Capsules - Part 2a EU Dossier
Study date
2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273603
Author
Dechra
Title
Excipient Specification
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273604
Author
Dechra
Title
Permit Application
Study date
2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273613
Author
Dechra
Title
Method Validation Report
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273614
Author
Dechra
Title
Packaging Specification
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273593
Author
McClure, M.R.
Title
Vetoryl 20mg Capsules Chemistry & Manufacture Part 2 Overview
Study date
June 2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273609
Author
Dechra
Title
Vetoryl 10mg Stability Trial Report
Study date
2005
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273610
Author
Dechra
Title
Vetoryl 30mg Stability Trial Report
Study date
2008
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273611
Author
Dechra
Title
Vetoryl 20mg Stability Trial Report Interim
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273615
Author
McClure, M.R.
Title
Vetoryl 20mg Capsules Efficacy & Safety Part 8 Overview
Study date
2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273616
Author
Dechra
Title
Report DPDR230
Study date
2023
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
273617
Author
Dechra
Title
Periodic Safety Update Report V/PV/11
Study date
2021
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Date

Application Date

Application No

Application Number

144720
Product/Active constituent Name

Application Product Name

ABATAK DUAL COMBINATION DRENCH FOR SHEEP

Application details

Product name:

ABATAK DUAL COMBINATION DRENCH FOR SHEEP

Product number:

95111

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

The purpose of this application is to approve product ABATAK DUAL LONG ACTING BARBERS POLE WORM DRENCH FOR SHEEP containing 1 g/L ABAMECTIN and 50 g/L CLOSANTEL

Reference details:

63259 - AVOMEC DUEL BROAD SPECTRUM DRENCH FOR SHEEP WITH BARBERS POLE LONG ACTION

Active constituents:

Active constituent name
82843 - ABAMECTIN
Active constituent name
92349 - Closantel sodium

Description of data provided:

Data no
276187
Author
Abbey Laboratories Pty Ltd
Title
Finished product specifications
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276188
Author
Abbey Laboratories Pty Ltd
Title
Batch Analysis
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276189
Author
Abbey Laboratories Pty Ltd
Title
Validation Analytical method
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276186
Author
Abbey Laboratories Pty Ltd
Title
Manufacturing Process
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276190
Author
Abbey Laboratories Pty Ltd
Title
Chemistry summary
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276184
Author
Abbey Laboratories pty Ltd
Title
Formulation details
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276185
Author
Abbey Laboratories Pty Ltd
Title
Raw materials specifications
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276192
Author
Abbey Laboratories pty Ltd
Title
Packaging and labelling
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276191
Author
Abbey Laboratories Pty Ltd
Title
stability data
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276194
Author
Anonymous
Title
APPENDIX 1- Efficacy Trial -I
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276195
Author
Anonymous
Title
APPENDIX 3 - Efficacy Trial -III
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276196
Author
Anonymous
Title
APPENDIX 2 - Efficacy Trial -II
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276197
Author
Abbey Laboratories pty Ltd
Title
Part A literature support for scientific Argument
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276206
Author
Guerrero,J et al.
Title
Closantel - A review of its antiparasitic activity
Study date
1984
Authorising party
Public
Auth party contact address
-
Data no
276202
Author
EMEA
Title
The European Agency for the Evaluation of Medicinal products, Veterinary Medicines Evaluation Unit. Committee for Veterinary Medicinal Products; Abamectin Summary report
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
276203
Author
EFSA
Title
European Food Safety Authority Scientific Opinion on the safety and efficacy of citric acid when used as a technological additive (preservative) for all animal species. EFSA panel on Additives and products or Substances used in Animal Feed (FEEDAP) Scientific opinion,
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
276204
Author
EMEA
Title
The European Agency for the Evaluation of Medicinal products, Veterinary Medicines Evaluation Unit. Committee for Veterinary Medicinal Products; Overall summary of the scientific evaluation of veterinary medicinal products containing 50 mg closantel per ml (as single active substance) presented as solutions for injection for subcutaneous use in sheep
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
276211
Author
Reinemeyer C.R. and. Courtney C.H.
Title
Chapter 47-Antinematodal drugs
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
276212
Author
Rowe R.C., Sheskey P.J. et al
Title
Handbook of Pharmaceutical Excipients
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
276298
Author
Abbey Laboratories Pty Ltd
Title
Proposed product label
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276299
Author
Abbey Laboratories Pty Ltd
Title
Efficacy summary
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276300
Author
Abbey Laboratories Pty Ltd
Title
Scientific argument to support Efficacy and safety of the proposed product backed by scientific literature
Study date
Jul 2024
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276208
Author
Hunt, P.W. Knox, M.R.et al
Title
Genetic and phenotypic differences between isolates of Haemonchus cortus in Australia.
Study date
2008
Authorising party
Public
Auth party contact address
-
Data no
276223
Author
Venkatesh,R et al
Title
Closantel - A lesser-known evil.
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
276193
Author
Abbey Laboratories Pty Ltd
Title
Scientific argument to support Efficacy and Safety of proposed product
Study date
Jul 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
276207
Author
Hennessy, D.R. Sangster,N.C et al.
Title
Comparative pharmacokinetic disposition of closantel in sheep and goats
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
276205
Author
Foreyt, J.W.
Title
Efficacy of In- feed formulation Ivermectin against Psoroptes Spp in bighorn sheep
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
276213
Author
Shoop, W.L. Ostlind, D.A et al.
Title
Avermectins and Milbemycins against Fasciola hepatica: In vivo receptor binding.
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
276214
Author
Singh, P et al
Title
Pharmacokinetics of abamectin in sheep, goat and deer
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
276215
Author
Jambre et al
Title
Efficacy of combination anthelmintics against multiple resistant strains of sheep nematodes
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
276218
Author
Wooster et al.
Title
Reduced efficacy of ivermectin, abamectin and moxidectin against field isolates of Haemonchus contortus.
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
276219
Author
Sivajyothi.S., Sudhakar.B et al
Title
Therapeutic efficacy of Closantel against different Gastrointestinal Parasites in Sheep.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
276220
Author
Strong, L. Brown, T.A. et al
Title
.Avermectins in insect control and biology: a review.
Study date
1987
Authorising party
Public
Auth party contact address
-
Data no
276221
Author
Suarez,G. CastellS, D.et al
Title
Therapeutic advantages of combined use of closantel and moxidectin in lambs parasitized with gastrointestinal nematodes.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
276222
Author
Prestons, S. Piedrafita,D et al.
Title
The current status of antihelmintic resistance in a temperate region of Australia Implications for small ruminant farm management.
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
276198
Author
Alka, R.M. Gopal, K.S etal
Title
Efficacy of abamectin against ivermectin-resistant strain of Trichostrongylus colubriformis in sheep
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
276199
Author
Bello, H.J.S Lins, J.G.G et al
Title
Prophylactic Effects of Ivermectin and Closantel Treatment in the Control of Oestrus ovis Infestation in Sheep.
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
276200
Author
Beisser R.B and Love,S.J et al.
Title
Anthelmintic resistance in sheep nematodes in Australia.
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
276201
Author
Cervenik,V.F,Grabna.I et al
Title
Kinetics of Abamectin Disposition in Blood Plasma and Milk of Lactating Dairy Sheep and Suckling Lambs
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
276224
Author
Wester, T et al
Title
Efficacy of Closantel against Ivermectin and febendazole resistant Haemonchus sp. in sheep in Ontario
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
276209
Author
Maes, L et al.
Title
Flukicidal action of closantel against immature and mature Fasciola hepatica in experimentally infected rats and sheep
Study date
1988
Authorising party
Public
Auth party contact address
-
Data no
276210
Author
Playford, M.c. Smith, A.N. et al.
Title
Prevalence and severity of anthelmintic resistance in ovine gastrointestinal nematodes in Australia (2009?2012).
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
274357
Author
Abbey Laboratories Pty Ltd
Title
Product development Report
Study date
JUL24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
274358
Author
Abbey Laboratories Pty Ltd
Title
Residues summary
Study date
JUL24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia