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

148934
Product/Active constituent Name

Application Product Name

Z-11 HEXADECENYL ACETATE

Application details

Product name:

Z-11 HEXADECENYL ACETATE

Product number:

96325

Applicant Name:

AGNOVA TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a Z-9 TETRADECENYL ACETATE at 2.175 g/dispenser and Z-11 HEXADECENYL ACETATE at 0.325 g/dispenser slow-release generator (SR) product for mating disruption of fall armyworm (Spodoptera frugiperda) (FAW) in sweet corn, maize, popcorn and sorghum

Description of data provided:

Data no
288609
Author
Wampler, K., Rozzell, D., Tipton, T.
Title
Product Chemistry for Provivi Z-9-Tetradecenyl Acetate
Study date
20 June 2017
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288610
Author
Wampler, K., Rozzell, D., Tipton, T.
Title
Product Chemistry for Provivi Z-9-Tetradecenyl Acetate
Study date
20 June 2017
Authorising party
Provivi, Inc
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288611
Author
Mel Kaminsky
Title
(Z)-Teradec-9-en1-yl acetate (CAS No. 16725-53-4) Product Chemistry
Study date
7 June 2017
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288612
Author
Victor Li
Title
Z-11-Hexadecenyl Acetate Product Chemistry
Study date
26 April 2019
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288613
Author
Rozzell,D., Otte,K., Heel,T,.Tipton,T
Title
Product Chemistry for Pheron Z11-16Ac
Study date
January 2020
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288614
Author
Tipton, T.
Title
US EPA Confidential Statement of Formula for Pheron Z11-16A
Study date
1 Oct 2019
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288615
Author
Anon
Title
Provivi Pherogen Document J1C Confidential Product Information
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288616
Author
Earl-Eugene Ringpis
Title
Operating Procedure ? 0523.0 Total AI Content in SpoFr dispensers by GC-FID
Study date
2018
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288617
Author
Anon
Title
Renewal Report for Active Substances that are Straight Chain Lepidopteran Pheromones Finalised by the Standing Committee on Plants, Animals, Food and Feed on 18 May 2022 in View of the Renewal of the Approval of the Active Substances Straight Chain Lepidopteran Pheromones (acetates) as Low-Risk Active Substances, Straight Chain Lepidopteran Pheromones (aldehydes and alcohols) in Accordance w Regul
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
288618
Author
Anon
Title
Straight Chain Lepidopteran Pheromones (SCLPs).
Study date
2021
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148935
Product/Active constituent Name

Application Product Name

PROVIVI PHEROGEN Pheromone Dispenser

Application details

Product name:

PROVIVI PHEROGEN Pheromone Dispenser

Product number:

96326

Applicant Name:

AGNOVA TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a Z-9 TETRADECENYL ACETATE at 2.175 g/dispenser and Z-11 HEXADECENYL ACETATE at 0.325 g/dispenser slow-release generator (SR) product for mating disruption of fall armyworm (Spodoptera frugiperda) (FAW) in sweet corn, maize, popcorn and sorghum

Description of data provided:

Data no
288575
Author
Anon
Title
Anon
Study date
17 Apr 2020
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288576
Author
Earl-Eugene Ringpis
Title
Development and Validation of an Analytical Method for the Quantification of (Z)-9-Tetradecenyl Acetate and (Z)-11-Hexadecenyl Acetate in Sf Dispensers by GC-FID
Study date
29 March 2019
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288577
Author
Anon
Title
Batch Analyses: Active Constituents and Product
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288578
Author
Xavier Forcada Gisbert
Title
Pherogen Fall Army Worm (FAW) Dispenser Production SOP
Study date
Jan 2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288579
Author
Anon
Title
PROVIVITM FAW/PHEROGENTM SPOFR DISPENSER
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288580
Author
Anon
Title
Provivi Pherogen Document J1P Confidential Product Information
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288581
Author
Anon
Title
Provivi Pherogen Document J2 Confidential Product Information
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288582
Author
Anon
Title
Provivi Pherogen Document J3 Confidential Product Information
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288583
Author
Anon
Title
Pfovivi Pherogen Part 2 Chemistry June 2025
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288584
Author
Lei Jin
Title
Pherogen FAW Dispensers in Accelerated Storage Determinations for 14 Days at 540C in Physicochemical Determinations.
Study date
4 October 2024
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288717
Author
Anon.
Title
PROVIVI PHEROGEN Part 8 Efficacy and Safety
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288718
Author
Garcia Mungu??a, A.
Title
STUDY TO EVALUATE THE BIOLOGICAL EFFECTIVENESS OF THE PROVIVI FAW????? DISPENSER (9-TETRADECENYL Acetate + (Z)-Hexadec-11-Enyl Acetate) FOR THE CONTROL BY SEXUAL CONFUSION OF THE FALL ARMYWORM (Spodoptera frugiperda) moth in the cultivation of corn, carried out in the municipality of Campeche, Campeche.
Study date
2023
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288719
Author
Garcia Mungu??a, A.
Title
STUDY TO EVALUATE THE BIOLOGICAL EFFECTIVENESS OF THE PROVIVI FAW????? DISPENSER (9-TETRADECENYL Acetate + (Z)-Hexadec-11-Enyl Acetate) FOR THE CONTROL BY SEXUAL CONFUSION OF THE FALL ARMYWORM (Spodoptera frugiperda) moth in the cultivation of corn, carried out in the municipality of Nautla, Veracruz.
Study date
2023
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288720
Author
Lopez Martinez, V.
Title
Evaluation study of the biological effectiveness of the PROVIVI??? FAW dispenser (Z)-11-Hexadecenyl acetate (11.58%) + (Z)-9-Tetradecenyl acetate (77.49%) through sexual confusion of the fall armyworm moth (Spodoptera frugiperda) in the cultivation of corn (Zea mays) in Abasolo, Gto.
Study date
2018
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288721
Author
Morais Franchini, L. H.
Title
Evaluation of the efficacy of pheromone dispensers on the management of Spodoptera frugiperda in corn
Study date
2022
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288722
Author
Sunda, W., Mwatabu, E. and Kibiru, B.
Title
Evaluation of PHEROGENTM Dispenser SpoFr Dispenser impregnated with synthetic female Fall Army Worm (Spodoptera frugiperda) pheronmone Densities for Management of Fall Army Worm (FAW) on Maize under Kenyan Field Conditions.
Study date
2021
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288723
Author
Serrano, M.
Title
Evaluation of the effectiveness of FAW Film Dispenser Densities of 30 to 15??ha-1 For Trap Capture Reduction in Maize in Mexico, 2022
Study date
2023
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288724
Author
Litzow, D.
Title
EVALUATION OF DISPENSER RELEASED PHEROMONE FOR THE MATING DISRUPTION OF FALL ARMYWORM IN SWEET CORN Mulgowie Queensland Australia 2023
Study date
2023
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288725
Author
Litzow, D.
Title
EVALUATION OF DISPENSER RELEASED PHEROMONE FOR THE MATING DISRUPTION OF FALL ARMYWORM IN SWEET CORN Mulgowie Queensland Australia 2023
Study date
2023
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288726
Author
Lindsay, C.
Title
Evaluation of Dispenser Released FAW Pheromone in Sweet Corn, Maize of Sorghum Management Systems Burdekin, Queensland Australia 2023
Study date
2024
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288716
Author
Anon.
Title
PROVIVI PHEROGEN Part 7 Environment
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288585
Author
Anon
Title
Provivi Pherogen Document J5 Confidential Product Information
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288586
Author
Anon
Title
Provivi Pherogen Part 6 OHS June 2025 V2
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288715
Author
Anon.
Title
PROVIVI PHEROGEN Part 6 Occupational Health and Safety
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288587
Author
Alves, D Z.
Title
Acute Dermal Toxicity Study with the Test Item Pherogen Granulos FAW in Rats (Rattus norvegicus).
Study date
2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288588
Author
Alves, D Z.
Title
Assessment of Test Item Eye Irritation Potential Pherogen Granulos FAW by BCOP Method (Bovine Corneal Opacity and Permeability Test).
Study date
2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288589
Author
Alves, D Z.
Title
Acute Inhalation Toxicity Study with the Test Item Pherogen Granulos FAW in Rats (Rattus norvegicus).
Study date
2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288590
Author
Alves, D Z.
Title
Acute Oral Toxicity Study with the Test Item Pherogen Granulos FAW in Rats (Rattus norvegicus).
Study date
2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288591
Author
Alves, D Z.
Title
Acute Dermal Irritation/Corrosion Study with the Test Item Pherogen Granulos FAW in Rabbits (Oryctolagus cuniculus).
Study date
2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288592
Author
Alves, D Z.
Title
Evaluation of the Skin Sensitization Potential in the Mouse of Pherogen Granulos FAW Using the Local Lymph Node Assay (LLNA) by the BrdU-ELISA Method.
Study date
2023
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288593
Author
Anon
Title
Provivi Pherogen Document J4 Confidential Product Information
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288594
Author
Anon
Title
Provivi FAW Dispenser Label USA 22 Feb 18
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
288595
Author
Anon
Title
Conclusion on the Peer Review of the Pesticide Risk Assessment of the Active Substance Straight Chain Lepidopteran Pheromones (SCLPs). Appendix B - List of End Points for the Active Substance and the Representative Formulation.
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
288596
Author
Anon
Title
Provivi Pherogen Part 3 Toxicology June 2025
Study date
2025
Authorising party
Provivi, Inc.
Auth party contact address
1701 Colorado Ave, Santa Monica, CA 90404, USA
Data no
288597
Author
Anon
Title
Biopesticide Registration Action Documents. Straight Chain Lepidopteran Pheromones (SCLP).
Study date
2008
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

149131
Product/Active constituent Name

Application Product Name

GENFARM SPIROTETRAMAT 240 SC INSECTICIDE

Application details

Product name:

GENFARM SPIROTETRAMAT 240 SC INSECTICIDE

Product number:

92806

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Variation of product registration to add an alternative formulation spirotetramat 240 SC insecticide formulation for the control of various insect pests in cotton and certain fruit and vegetable crops..

Reference details:

94728 - Albaugh Spiromax 240 SC Insecticide

Active constituents:

Active constituent name
87328 - SPIROTETRAMAT

Description of data provided:

Data no
292119
Author
Anon
Title
Letter of support
Study date
8 July 2025
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
292120
Author
Anon
Title
Reference product details
Study date
10 July 2025
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
292121
Author
Anon
Title
Consent for use of protected information
Study date
1 July 2025
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

149133
Product/Active constituent Name

Application Product Name

SCOTTS LAWN BUILDER WEED, FEED & GREEN-UP

Application details

Product name:

SCOTTS LAWN BUILDER WEED, FEED & GREEN-UP

Product number:

47860

Applicant Name:

EVERGREEN GARDEN CARE AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to include a wider range of pack sizes.

Reference details:

64340 - AMGROW EXTRA STRENGTH FEEDER WEEDER FOR LAWNS
Date

Application Date

Application No

Application Number

149272
Product/Active constituent Name

Application Product Name

PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS

Application details

Product name:

PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS

Product number:

57941

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of product registration to make a minor formulation change that does not affect the physico-chemical properties of the product.

Description of data provided:

Data no
289427
Author
Not Identified
Title
Justification
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289428
Author
DAFF
Title
List of Approved Ingredients for Retail Packaged Veterinary Therapeutics and Cosmetics for Animals
Study date
8 February 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

149277
Product/Active constituent Name

Application Product Name

Prevequine Tablets for Horses

Application details

Product name:

Prevequine Tablets for Horses

Product number:

89888

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of product registration to make a minor formulation change that does not affect the physico-chemical properties of the product.

Active constituents:

Active constituent name
57947 - FIROCOXIB

Description of data provided:

Data no
289443
Author
Not Identified
Title
Justification
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289444
Author
DAFF
Title
List of Approved Ingredients for Retail Packaged Veterinary Therapeutics and Cosmetics for Animals
Study date
8 February 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

149155
Product/Active constituent Name

Application Product Name

F.S.A. Butroxydim 250 WG Herbicide

Application details

Product name:

F.S.A. Butroxydim 250 WG Herbicide

Applicant Name:

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use:

Registration of a 250 g/kg formulation of butroxydim for the control of certain grasses in a range of broadacre crops as per the directions for use.
Date

Application Date

Application No

Application Number

149128
Product/Active constituent Name

Application Product Name

APPARENT TEBUTHIURON 200 HERBICIDE

Application details

Product name:

APPARENT TEBUTHIURON 200 HERBICIDE

Product number:

69904

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Variation of product registration to add a formulation and formulators to the product's registration details.

Reference details:

69904 - APPARENT TEBUTHIURON 200 HERBICIDE
92986 - Foison Tebuthiuron 200 GR Herbicide

Active constituents:

Active constituent name
57789 - TEBUTHIURON

Description of data provided:

Data no
289739
Author
P Pentland
Title
69904 access
Study date
8 July 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
289738
Author
A Ericsson
Title
69904 AA letter
Study date
9 July 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date

Application Date

Application No

Application Number

149278
Product/Active constituent Name

Application Product Name

PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL

Application details

Product name:

PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL

Product number:

58093

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of product registration to make a minor formulation change that does not affect the physico-chemical properties of the product.

Active constituents:

Active constituent name
57947 - FIROCOXIB

Description of data provided:

Data no
289445
Author
Not Identified
Title
Justification
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289446
Author
DAFF
Title
List of Approved Ingredients for Retail Packaged Veterinary Therapeutics and Cosmetics for Animals
Study date
8 February 2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

148097
Product/Active constituent Name

Application Product Name

Apitraz 500 mg bee-hive strips for honey bees

Application details

Product name:

Apitraz 500 mg bee-hive strips for honey bees

Product number:

96079

Applicant Name:

LABORATORIOS CALIER, S.A.

Application purpose and description of use:

Registration of a 500 mg Amitraz/strip, bee-hive strip product for treatment of external parasitosis in honey bees caused by Varroa destructor sensitive to amitraz, and approval of new source of the active amitraz.

Reference details:

88615 - APIVAR 500 MG BEE HIVE STRIPS FOR HONEY BEES

Active constituents:

Active constituent name
96132 - Amitraz

Description of data provided:

Data no
289316
Author
Not identified
Title
REGISTRATION CERTIFICATE FOR PHYTOSANITARY PURPOSES
Study date
16 June 2000
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
289317
Author
Not identified
Title
Manufacturing flowchart
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
289318
Author
Not identified
Title
GMP Certificate
Study date
15 April 2024
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
289319
Author
Not identified
Title
GMP Certificate
Study date
22 November 2024
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285201
Author
Laboratorios Calier, S.A.
Title
Test on the finished product
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286734
Author
Laboratorios Calier, S.A.
Title
Test on the finished product: specifications at release and control tests
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286735
Author
Laboratorios Calier, S.A.
Title
Test on the finished product: ANNEX-1: Analytical validation method for the determination of amitraz in the APITRAZ. Report no.: API A 030 Q 12. Validation Report + tables + chromatograms.
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286736
Author
Laboratorios Calier, S.A.
Title
Test on the finished product: ANNEX- 2- Analytical validation method for IRGANOX 1010 in APITRAZ. Report No. API A 004 Q13. Validation Report + tables + chromatograms.
Study date
2013
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286737
Author
Laboratorios Calier, S.A.
Title
Test on the finished product: ANNEX-3- Validation of test for microbiological control
Study date
2013
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286738
Author
Beaphar, B.V.
Title
DESCRIPTION OF THE MANUACTURING METHOD: VALIDATION OF THE MANUFACTURING PROCESS (REPORT No.: BP00372957)
Study date
2021
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285198
Author
Laboratorios Calier, S.A.
Title
Packaging material
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285200
Author
Laboratorios Calier, S.A.
Title
CONTROL TESTS CARRIED OUT AT INTERMEDIATE STAGES OF THE MANUFACTURING PROCESS
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285189
Author
Laboratorios Calier, S.A.
Title
DESCRIPTION OF THE MANUFACTURING METHOD
Study date
2021
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285197
Author
Laboratorios Calier, S.A.
Title
EXCIPIENTS
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285185
Author
Laboratorios Calier, S.A.
Title
QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285186
Author
Laboratorios Calier, S.A.
Title
USUAL TERMINOLOGY
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285187
Author
Laboratorios Calier, S.A.
Title
QUANTITATIVE PARTICULARS
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285188
Author
Laboratorios Calier, S.A.
Title
DEVELOPMENT PHARMACEUTICS
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286739
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: ANNEX I RESULTS OF PRE-STABILITY STUDY
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286740
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: ANNEX II RESULTS ON THERMOGRAVIMETRIC ANALYSIS (TAG) AND DIFFERENCIAL SCANNING CALORIMETRY (DSC) ANALYSIS OF AMITRAZ
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286741
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: ANNEX III RELEASE STUDY OF AMITRAZ IN HIVES TREATED WITH APITRAZ.
REPORT No.: API A 0 42 Q 12
Study date
2013
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286742
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: ANNEX IV FORM AND DIMENSIONS OF THE STRIPS
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286743
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: ANNEX V UNIFORM OF DOSAGE
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286744
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: ANNEX VI COMPARATIVE IN VITRO DISSOLUTION STUDY OF APITRAZ. REPORT No.: API A 005 Q 13
Study date
2013
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286745
Author
Laboratorios Calier
Title
DEVELOPMENT PHARMACEUTICS: VALIDATION OF THE METHOD FOR DETERMINATION OF THE DISSOLUTION PROFILE OF AMITRAZ. REPORT NO.: API A 006 Q 13
Study date
2013
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286746
Author
Laboratorios Calier, S.A.
Title
Finished product stability: Specifications at shelf-life.
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286747
Author
Laboratorios Calier, S.A.
Title
Finished product stability: Stability study to 12 months of shelf-life
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286748
Author
Laboratorios Calier, S.A.
Title
Finished product stability: Stability study to 18 months of shelf-life
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286749
Author
Laboratorios Calier, S.A.
Title
Finished product stability: Validation of the analytical method for the determination of related substances of amitraz in APITRAZ. (STUDY No. API A 031 Q 12) . Validation Report + tables + chromatograms.
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285203
Author
Laboratorios Calier, S.A.
Title
Finished product stability
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285216
Author
Laboratorios Calier, S.A.
Title
Clinical trials
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286750
Author
Laboratorios Calier, S.A.
Title
Evaluation of the efficacy of veterinary medicinal product formulated with amitraz against naturally infected bees with Varroa destructor in field-trial conditions. Study AMZ A 022 E 11.
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286751
Author
Laboratorios Calier, S.A.
Title
Evaluation of the efficacy of veterinary medicinal product formulated with amitraz against naturally infected bees with Varroa destructor in field-trial conditions. Study AMZ A 018 E 14.
Study date
2014
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286752
Author
Laboratorios Calier, S.A.
Title
Comparative efficacy and safety study of the use of Apitraz during 6 and 10 weeks for the treatment of external parasitosis in honey bees caused by Varroa destructor. Study API A 053 E 21.
Study date
2022
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286753
Author
DAM DZIERZAWSKI, WOJCIECH CYBULSKI.
Title
Evaluation of the efficacy of Apiwarol AS
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
286754
Author
J.-P. FAUCON, P. DRAJNUDEL, M.P. CHAUZAT et M. AUBERT
Title
Contr?le de l?efficacit? du m?dicament APIVAR ND contre Varroa destructor, parasite de l?abeille domestique.
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
285214
Author
Laboratorios Calier, S.A.
Title
Development of resistance
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285215
Author
Laboratorios Calier, S.A.
Title
Tolerance in the target species
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286755
Author
Laboratorios Calier, S.A.
Title
Evaluation of the safety of veterinary medicinal product formulated with amitraz against naturally infected bees with Varroa destructor in field-trial conditions (Study No.:AMZ A 050 S 11)
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286756
Author
Laboratorios Calier, S.A.
Title
Comparative efficacy and safety study of the use of Apitraz during 6 and 10 weeks for the treatment of external parasitosis in honey bees caused by Varroa destructor (Study No.:API A 053 E 21:)
Study date
2021
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286757
Author
Laboratorios Calier, S.A.
Title
Environmental Risk Assessment
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285209
Author
Laboratorios Calier, S.A.
Title
Enviromental Risk Assessment
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285199
Author
Laboratorios Calier, S.A.
Title
Transmissible Spongiform Encephalopathy (TSE) declaration
Study date
2017
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285210
Author
Laboratorios Calier, S.A.
Title
Precise identification of the product concerned by the application
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286758
Author
Laboratorios Calier, S.A.
Title
Precise identification of the product concerned by the application
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285183
Author
Laboratorios Calier, S.A.
Title
SUMMARY OF PRODUCT CHARACTERISTICS
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285184
Author
Laboratorios Calier, S.A.
Title
LABELLING AND PACKAGE LEAFLET
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285205
Author
Laboratorios Calier, S.A.
Title
Pharmacology
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285213
Author
Laboratorios Calier, S.A.
Title
Pharmacology
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286759
Author
Anthony P. Davenport, David B. Morton, and Peter D. Evans.
Title
The action of Formamidines on Octopamine Receptors in the Locust.
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
286760
Author
Roger G.H. Downer, John W. D. Gole and Gregory L. Orr
Title
Interaction of Formamidines with Octopamine, Dopamine and 5 ? Hydroxytryptamine-sensitive Adenylate Cyclase in the Nerve Cord of Periplaneta Americana
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
286761
Author
Michael P. Osborne.
Title
Actions of Formamidines, Local Anesthetics, Octopamine and Related Compounds upon the Electrical Activity of Neurohaemal Organs of the Stick Insect (Carausius morosus) and Sense Organs of Fly Larvae (Musca domestica; Calliphora erythrocephala)
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
286762
Author
David P. Giles and David N. Rothwell.
Title
The Sub-lethal Activity of Amidines on Insects and Acarids
Study date
1983
Authorising party
Public
Auth party contact address
-
Data no
286763
Author
L. K. Cullen & J.A. Reynoldson
Title
Cardiovascular and respiratory effects of the acaricide amitraz
Study date
1987
Authorising party
Public
Auth party contact address
-
Data no
286764
Author
Walter H. Hsu and Sandra V. McNeel
Title
Amitraz-induced prolongation of gastrointestinal transit and bradycardia in dogs and their antagonism by yohimbine: Preliminary study
Study date
1985
Authorising party
Public
Auth party contact address
-
Data no
286765
Author
Walter H. Hsu, David L. Hopper
Title
Effects of Yohimbine on amitraz-induced CNS depression and bradycardia in dogs.
Study date
1986
Authorising party
Public
Auth party contact address
-
Data no
286766
Author
Lucio G. Costa, Giovanni Olibet and Sheldon D. Murphy
Title
Alpha2-Adrenoceptos as a Target for Formamidine Pestidides: In Vitro and in Vivo Studies in Mice
Study date
1988
Authorising party
Public
Auth party contact address
-
Data no
286767
Author
Michael A. Pass and Tony D. Mogg
Title
Effect of Amitraz and its metabolites on intestinal motility.
Study date
1991
Authorising party
Public
Auth party contact address
-
Data no
286768
Author
Michael A. Pass and Alan A. Seawright
Title
Effect of amitraz on contractions of the guinea-pig ileum in vitro
Study date
1982
Authorising party
Public
Auth party contact address
-
Data no
286769
Author
G.J.Turnbull
Title
Animal Studies on the Treatment of Poisoning by Amitraz (a Formamidine Pesticide) and Xylene
Study date
1983
Authorising party
Public
Auth party contact address
-
Data no
286770
Author
Michel Bounias, Jean Fran?ois Andre & Irena Kruk
Title
Syneristic and molecular interactions between the formamidine amitraz and copper (II) sulfate, used against the mite Varroa jacobsoni O., a parasite of the honeybee Apis mellifera L.
Study date
1993
Authorising party
Public
Auth party contact address
-
Data no
286771
Author
T.B. Alavoine.
Title
Essais de potentialisation de l?amitraz par le butoxyde de pip?ronyle contre la varroose d?e l?abeille ? Th?se pour le doctorat v?t?rinaire
Study date
1992
Authorising party
Public
Auth party contact address
-
Data no
286772
Author
Charles O. Knowles and Herman J. Benezet
Title
Excretion Balance, metabolic fate and tissue residues following treatment of rats with amitraz and N?- (2,4-Dimethylphenyl)-N-Methylformamidine.
Study date
1981
Authorising party
Public
Auth party contact address
-
Data no
286773
Author
Penelope B. Baker and D.R
Title
Co-metabolism of the Ixodicide Amitraz
Study date
1977
Authorising party
Public
Auth party contact address
-
Data no
286774
Author
Office of Pesticide Programs. Office of Toxic Substances. U.S. Environmental Protection Agency
Title
Position Document 3 ? Special Pesticide Review Division.
Study date
1979
Authorising party
Public
Auth party contact address
-
Data no
286775
Author
Laborotorios Calier, S.A.
Title
Pharmacology
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286776
Author
Health Assessment Section Medical Toxicology Branch, Department Pesticide Regulation California Environmental Protection Agency.
Title
Amitraz Risk Characterization.
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
285208
Author
Laboratorios Calier, S.A.
Title
User safety
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285212
Author
Laboratorios Calier, S.A.
Title
Residue analytical method
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286777
Author
Laboratorios Calier, S.A. / Kymos Pharma Service, S.L.
Title
Validation of an HPLC-MS/MS method for the determination of Amitraz and metabolites in honey. Study No.: S12/120-CA
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286778
Author
Laboratorios Calier, S.A.
Title
Study AMZ A 047 S 11: Residue depletion study after administration of Apitraz in honey bees.
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286779
Author
Laboratorios Calier, S.A.
Title
Study API S 020 S 22: Residue depletion study after administration of Apitraz in honey bees during 6 and 10 weeks.
Study date
2022
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285211
Author
Laboratorios Calier, S.A.
Title
Residue studies
Study date
2012
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285206
Author
Laboratorios Calier, S.A.
Title
Toxicology
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285207
Author
Laboratorios Calier, S.A.
Title
Other requirements
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
286780
Author
J.-J. Larsen.
Title
944. Amitraz (JMPR Evaluations 1998 Part II Toxicology-First draft
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
286781
Author
J.-J. Larsen
Title
944. Amitraz (JMPR Evaluations 1998 Part II Toxicology). First draft
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
286782
Author
Thompson, Brown, Ball, Medwin and Bew
Title
First report of Varroa destructor resistance to pyrethroids in the UK.
Study date
2002
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148266
Product/Active constituent Name

Application Product Name

Amitraz

Application details

Product name:

Amitraz

Active name:

Amitraz

Applicant Name:

LABORATORIOS CALIER, S.A.

Application purpose and description of use:

Registration of a 500 mg Amitraz/strip, bee-hive strip product for treatment of external parasitosis in honey bees caused by Varroa destructor sensitive to amitraz, and approval of new source of the active amitraz.

Description of data provided:

Data no
285541
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285542
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285543
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285544
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285545
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285546
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285547
Author
Laboratorios Calier, S.A.
Title
ACTIVE SUBSTANCE ANALYTICAL METHODS
Study date
2020
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
289314
Author
Not identified
Title
Certificates of Analysis
Study date
2022
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
289315
Author
Not identified
Title
Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
289320
Author
Not identified
Title
Information on source of Active Constituent
Study date
20 May 2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285549
Author
Laboratorios Calier, S.A.
Title
Precise identification of the product concerned by the application
Study date
2025
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Data no
285548
Author
Laboratorios Calier, S.A.
Title
Active substance stability
Study date
2011
Authorising party
Applicant
Auth party contact address
BARCELONES 26 (PLA DEL RAMASSAR) LES FRANQUESES DEL VALLES BARCELONA Spain
Date

Application Date

Application No

Application Number

148937
Product/Active constituent Name

Application Product Name

Jadesheen Group Glyphosate 540 Herbicide

Application details

Product name:

Jadesheen Group Glyphosate 540 Herbicide

Product number:

96327

Applicant Name:

JADESHEEN BIOTECH CO., LTD.

Application purpose and description of use:

Registration of a glyphosate 540 g/l (present as the potassium salt) soluble liquid herbicide product for the non selective control of many annual and perennial weeds.

Reference details:

60623 - RHODIA GLYPHOSATE POTASSIUM HIGH LOAD HERBICIDE

Active constituents:

Active constituent name
56663 - GLYPHOSATE
Date

Application Date

Application No

Application Number

149109
Product/Active constituent Name

Application Product Name

Clothes Moth Pheromone Traps

Application details

Product name:

Clothes Moth Pheromone Traps

Product number:

96371

Applicant Name:

STV INTERNATIONAL LTD

Application purpose and description of use:

Registration of a 0.2 g/kg Koiginal I & Koiginal II in a ready to use bait formulation to attract and trap clothing moths and carpet moths.

Reference details:

89956 - HOVEX CLOTHING MOTH TRAP
62648 - COMFORTIS (SPINOSAD) CHEWABLE TABLETS FOR DOGS 18.1 - 27KG
95062 - NO Clothes Moths Pheromone Traps

Description of data provided:

Data no
289386
Author
anon
Title
COA
Study date
2024
Authorising party
Applicant
Auth party contact address
FORGE HOUSE LITTLE CRESSINGHAM THETFORD, NORFOLK IP25 6ND NORFOLK United Kingdom
Data no
289387
Author
STV Int
Title
Declaration
Study date
2025
Authorising party
Applicant
Auth party contact address
FORGE HOUSE LITTLE CRESSINGHAM THETFORD, NORFOLK IP25 6ND NORFOLK United Kingdom
Data no
289388
Author
STV Int
Title
Executive Summary
Study date
2025
Authorising party
Applicant
Auth party contact address
FORGE HOUSE LITTLE CRESSINGHAM THETFORD, NORFOLK IP25 6ND NORFOLK United Kingdom
Date

Application Date

Application No

Application Number

149200
Product/Active constituent Name

Application Product Name

OSURNIA EAR GEL FOR DOGS

Application details

Product name:

OSURNIA EAR GEL FOR DOGS

Product number:

69931

Applicant Name:

DECHRA LTD

Application purpose and description of use:

Variation of label approval to include information to reflect overseas pharmacovigilance reports.

Active constituents:

Active constituent name
82454 - BETAMETHASONE ACETATE
Active constituent name
82453 - FLORFENICOL
Active constituent name
82455 - TERBINAFINE
Active constituent name
86595 - FLORFENICOL

Description of data provided:

Data no
289268
Author
Veterinary Medicines Directorate
Title
Labeling and Package Leaflet
Study date
April 2025
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
289263
Author
European Medicines Agency
Title
Veterinary Signal Assessment Report 1
Study date
30 December 2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
289266
Author
European Medicines Agency
Title
Veterinary Signal Assessment Report 4
Study date
30 December 2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
289267
Author
European Medicines Agency
Title
Veterinary Signal Assessment Report 5
Study date
30 December 2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
289264
Author
European Medicines Agency
Title
Veterinary Signal Assessment Report 2
Study date
30 December 2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
289265
Author
European Medicines Agency
Title
Veterinary Signal Assessment Report 3
Study date
30 December 2024
Authorising party
Applicant
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
289262
Author
Committee for Veterinary Medicinal Products
Title
Rapporteur's variation assessment report - Reduced 30 day
Study date
13 March 2025
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

149247
Product/Active constituent Name

Application Product Name

Quali-Pro Twister Insecticide

Application details

Product name:

Quali-Pro Twister Insecticide

Product number:

96419

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 240 g/L indoxacarb + 80 g/L novaluron suspension concentrate product for uses as proposed in the Directions for Use table.

Reference details:

88077 - PLEMAX Insecticide

Active constituents:

Active constituent name
84866 - Indoxacarb
Active constituent name
82333 - Indoxacarb
Active constituent name
52874 - NOVALURON

Description of data provided:

Data no
289676
Author
Gengos, M.
Title
Consent for use of protected information with limitation on use.
Study date
21 July 2025
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
289677
Author
Gengos, M.
Title
Manufacturer's declaration for Quali-Pro Twister Insecticide.
Study date
23 July 2025
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date

Application Date

Application No

Application Number

148927
Product/Active constituent Name

Application Product Name

Pyraclostrobin

Application details

Product name:

Pyraclostrobin

Active name:

Pyraclostrobin

Applicant Name:

HUNAN HAILI CHEMICAL INDUSTRY CO., LTD

Application purpose and description of use:

Approval of Pyraclostrobin for use in agricultural chemical products.

Description of data provided:

Data no
289205
Author
N. Tagliacozzi Galvao
Title
Qualitative and Quantitative Profile of Pyraclostrobin Technical (Five Batch Analysis)
Study date
15/09/2022
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
289206
Author
Anon
Title
Declaration of composition
Study date
24/06/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296629
Author
Anon
Title
DoC
Study date
05/12/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296630
Author
N. Tagliacozzi Galv o
Title
Analytical method validation and content of Hydrazine Hydrate and Nickel in Pyraclostrobin Technical
Study date
27/10/2023
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296631
Author
Anon
Title
Batch size information
Study date
05/12/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296628
Author
Anon
Title
Description of Manufacturing process of: Pyraclostrobin TC
Study date
12/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
289204
Author
Anon
Title
Manufacturing Process of Pyraclostrobin TC
Study date
06/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Date

Application Date

Application No

Application Number

148960
Product/Active constituent Name

Application Product Name

Thiophanate-Methyl

Application details

Product name:

Thiophanate-Methyl

Active name:

Thiophanate-Methyl

Applicant Name:

HUNAN HAILI CHEMICAL INDUSTRY CO., LTD

Application purpose and description of use:

Approval of Thiophanate-Methyl for use in agricultural chemical products.

Description of data provided:

Data no
289210
Author
A.K. Agrahari
Title
Validation of analytical methods for determination of Thiophanate - Methyl and its associated impurities in Thiophanate - Methyl technical sample
Study date
03/01/2022
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
289211
Author
Anon
Title
Declaration of composition
Study date
06/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
289209
Author
A.K. Agrahari
Title
Preliminary analyses of five representative production batches of Thiophanate - Methyl technical grade active ingredient (TGAI) to determine percent Thiophanate - Methyl and to quantify its associated impurities
Study date
03/01/2022
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
289208
Author
Anon
Title
Manufacturing Process of Thiophanate-Methyl TC
Study date
06/2025
Authorising party
Applicant
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Date

Application Date

Application No

Application Number

148513
Product/Active constituent Name

Application Product Name

CHLOROTHALONIL

Application details

Product name:

CHLOROTHALONIL

Active name:

CHLOROTHALONIL

Applicant Name:

Shandong Dacheng Bio-chemical Co., Ltd

Application purpose and description of use:

Approval of chlorothalonil for use in agricultural chemical products.

Description of data provided:

Data no
286819
Author
Anon.
Title
Final Report. Preliminary analysis and validation of analytical methods of CHLOROTHALONIL 98.5% TC ??? Validation of the analytical methodology for active ingredient, impurities and subsequent 5-batch analysis of CHLOROTHALONIL 98.5% TC.
Study date
7 April 2020
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286820
Author
Anon.
Title
Final Report. CONFIDENTIAL ATTACHMENT. Preliminary analysis and validation of analytical methods of CHLOROTHALONIL 98.5% TC ??? Validation of the analytical methodology for active ingredient, impurities and subsequent 5-batch analysis of CHLOROTHALONIL 98.5% TC.
Study date
7 April 2020
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286821
Author
Anon.
Title
Final Report. CONFIDENTIAL ATTACHMENT. Preliminary analysis and validation of analytical methods of CHLOROTHALONIL 98.5% TC ??? Validation of the analytical methodology for active ingredient, impurities and subsequent 5-batch analysis of CHLOROTHALONIL 98.5% TC. Annex 1
Study date
7 April 2020
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286822
Author
Anon.
Title
Final Report. CONFIDENTIAL ATTACHMENT. Preliminary analysis and validation of analytical methods of CHLOROTHALONIL 98.5% TC ??? Validation of the analytical methodology for active ingredient, impurities and subsequent 5-batch analysis of CHLOROTHALONIL 98.5% TC.
Study date
7 April 2020
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286823
Author
Anon.
Title
Certificates of Analysis ??? Chlorothalonil Technical. Shandong Dacheng Bio-Chemical Co., Ltd
Study date
29 December 2024
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286828
Author
Anon.
Title
Chromatograms and Raw Data - 2024 Batches of Chlorothalonil
Study date
3 April 2025
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286818
Author
Anon.
Title
Chorothalonil Active Constituent - Submission for Approval to the Australian Pesticides and Veterinary Medicines Authority
Study date
16 April 2025
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286826
Author
Anon.
Title
Compilation of raw material SDS
Study date
April 2025
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286827
Author
Anon.
Title
Declaration of Composition for Chlorothalonil Technical Active Constituent
Study date
April 2025
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286824
Author
Anon.
Title
Shandong Dacheng Bio-Chemical Co., Ltd. ??? Chlorothalonil Technical Manufacturing Process
Study date
June 2020
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Data no
286825
Author
Anon.
Title
Certificate of Business Registration - Autumn Australia Pty Ltd
Study date
June 2019
Authorising party
Applicant
Auth party contact address
No.222 Changguo East Road, Zhangdian District Zibo City China
Date

Application Date

Application No

Application Number

149080
Product/Active constituent Name

Application Product Name

Oxadiazon

Application details

Product name:

Oxadiazon

Active name:

Oxadiazon

Applicant Name:

ANHUI KELIHUA CHEMICAL CO., LTD.

Application purpose and description of use:

Approval of Oxadiazon for use in agricultural chemical products.

Description of data provided:

Data no
289560
Author
Stephen Chen
Title
Five Batch Analysis of Oxadiazon Technical
Study date
2022/05/13
Authorising party
Applicant
Auth party contact address
Fifth Jintai Road, Chemical Industrial Park, Suzhou Economic & Technological Development Zone SUZHOU People's Republic of China
Data no
289559
Author
anonymous
Title
Manufacturing process of Oxadiazon Technical
Study date
2025
Authorising party
Applicant
Auth party contact address
Fifth Jintai Road, Chemical Industrial Park, Suzhou Economic & Technological Development Zone SUZHOU People's Republic of China
Data no
289561
Author
Zhang weibo
Title
Declaration of composition
Study date
2025/06/10
Authorising party
Applicant
Auth party contact address
Fifth Jintai Road, Chemical Industrial Park, Suzhou Economic & Technological Development Zone SUZHOU People's Republic of China
Data no
289562
Author
Zhang weibo
Title
Declaration letter
Study date
2025/06/10
Authorising party
Applicant
Auth party contact address
Fifth Jintai Road, Chemical Industrial Park, Suzhou Economic & Technological Development Zone SUZHOU People's Republic of China
Data no
289563
Author
anonymous
Title
Oxadiazon chemistry and manufacture
Study date
2025/6/18
Authorising party
Applicant
Auth party contact address
Fifth Jintai Road, Chemical Industrial Park, Suzhou Economic & Technological Development Zone SUZHOU People's Republic of China
Date

Application Date

Application No

Application Number

148795
Product/Active constituent Name

Application Product Name

ACP Regrowth Extra Herbicide

Application details

Product name:

ACP Regrowth Extra Herbicide

Product number:

96283

Applicant Name:

AUSTRALIS CROP PROTECTION PTY LTD

Application purpose and description of use:

Registration of a300 g/L TRICLOPYR PRESENT AS THE BUTOXYETHYL ESTER, 100 g/L PICLORAM PRESENT AS THE HEXYLOXYPROPYLAMINE SALT and 8 g/L AMINOPYRALID PRESENT AS HEXYLOXYPROPYLAMINE SALT, Emulsifiable Concentrate product for control of a range of environmental and noxious woody and herbaceous weeds as specified in the Directions for Use table.

Reference details:

60830 - GRAZON EXTRA HERBICIDE

Active constituents:

Active constituent name
93742 - Aminopyralid
Active constituent name
66576 - PICLORAM
Active constituent name
66848 - TRICLOPYR BUTOXYETHYL ESTER

Description of data provided:

Data no
288034
Author
Anon
Title
Aminpyralid- Picloram- Triclopyr Chemisty package
Study date
April 2025
Authorising party
Applicant
Auth party contact address
SHOP 4, 30 HEBER STREET MOREE Australia
Data no
288035
Author
Anon
Title
Scientific argument for Aminopyralid picloram triclopyr formulation
Study date
April 2025
Authorising party
Applicant
Auth party contact address
SHOP 4, 30 HEBER STREET MOREE Australia