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

151319
Product/Active constituent Name

Application Product Name

Cevac MD HVT

Application details

Product name:

Cevac MD HVT

Product number:

96950

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of a 2000pfu/dose Marek's disease virus serotype 3, strain FC-126 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens

Active constituents:

Active constituent name
96949 - Cell-associated live turkey herpes virus (HVT, Marek’s disease virus), serotype 3, strain FC

Description of data provided:

Data no
299330
Author
R Banks
Title
Cevac MD HVT Detailed and Critical Summary on Part 2 Quality Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299384
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299347
Author
Ceva-Phylaxia Co Ltd
Title
SPF Flock test results
Study date
2022
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299393
Author
Islam AFMF, Walkden-Brown SW, Groves PJ and Underwood GJ
Title
Effects of vaccine dose, virus challenge dose and interval from vaccination to challenge on protection of broiler chickens against Marek's disease virus challenge
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
299390
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Certificate of Manufacture (approved GMP)
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299327
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Part 2 Safety Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299364
Author
Ceva-Phylaxia Co Ltd
Title
Validation of a PCR method
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299376
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299370
Author
Animal Health and Veterinary Laboratories Agency
Title
OVERDOSE SAFETY & RESIDUAL PATHOGENICITY
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299333
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Day 70 Preliminary Assessment Report
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299350
Author
Free University Berlin Institute of Poultry Diseases
Title
Validation of an ELISA for detection of antibodies to avian nephritis virus
Study date
2005
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299387
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299341
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT ES/V0264/001/R/001 D90 End of Procedure
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299396
Author
Bioproperties Pty Ltd
Title
Executive Summary: Item 2 Cevac MD HVT
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299344
Author
Spanish Agency of Medicines and Medical Devices
Title
Assessment of the responses to day 15 variation assessment report ES/V/0264/001/IB/005
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299367
Author
Ceva-Phylaxia Co Ltd
Title
Batch Release Certificates
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299361
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF TITRATION METHOD
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299373
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299324
Author
Ceva-Phylaxia Co.Ltd
Title
Cevac MD HVT Summary of product Characteristics
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299359
Author
Ceva-Phylaxia Co Ltd
Title
Monoclonal antibody specificity test
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299336
Author
Ceva Sante Animale
Title
Pharmacovigilance statement
Study date
2024
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302061
Author
Not Identified
Title
Cevac MD HVT Manufacturing Flowchart
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299382
Author
Ceva Phylaxia Co Ltd
Title
V054 VACCINE FIELD SAFETY AND EFFICACY TEST
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299388
Author
Ceva Phylaxia Co Ltd
Title
VALIDATION OF A REAL.TIME QUANTITATIVE PCR ASSAY
Study date
2013
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299342
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT List of Post Authorisation Submissions
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299345
Author
Ceva-Phylaxia Co Ltd
Title
Glass ampule specification and Certificate of Analysis
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299368
Author
Ceva-Phylaxia Co Ltd
Title
STABILITY STUDY
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299362
Author
Ceva-Phylaxia Co Ltd
Title
Validation of a PCR Method
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299325
Author
Ceva-Phylaxia Co.Ltd
Title
Cevac MD HVT Labelling and Package Leaflet
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299356
Author
Ceva-Phylaxia Co Ltd
Title
serum Certificates of Analysis/Suitability
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299379
Author
Ceva Phylaxia Co Ltd
Title
EFFICACY OF CEVAC MD HVT VACCINE
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302064
Author
Not Identified
Title
Steps of Manufacture - HVT Site 3
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299385
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299339
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Clinical Expert Statement
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299348
Author
Ceva-Phylaxia Co Ltd
Title
Technology Transfer Qualification Summary report
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299391
Author
Bioproperties
Title
Justification for waiving local field trials
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299328
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Part 4 Efficacy Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299365
Author
Ceva-Phylaxia Co Ltd
Title
Validation of PGR-based methods
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299371
Author
Animal Health and Veterinary Laboratories Agency
Title
EXAMINATION OF A MAREK'S DISEASE VACCTNE FOR SHED AND SPREAD
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299380
Author
Ceva Phylaxia Co Ltd
Title
Efficacy of CEVAC MD HVT vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299334
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Day 120 Assessment of the Consolidated List of Questions
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299357
Author
Ceva-Phylaxia Co Ltd
Title
Validation of the Sterility Test
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299386
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299397
Author
National Food Chain Safety Office
Title
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299340
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Clinical Expert Statement
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299351
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological materials not listed in PhEur CErtificates of Analysis
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299374
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299377
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299383
Author
Ceva Phylaxia Co Ltd
Title
VACCINE FIELD SAFETY AND EFFICACY TEST
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299354
Author
Ceva-Phylaxia Co Ltd
Title
CoA Origin statement, Irradiation certificate/reports
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299360
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF TITRATION METHOD
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299331
Author
Dr Rhona Banks FRSB PhD of RA-Elect Ltd
Title
R Banks
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302062
Author
Not Identified
Title
Steps of Manufacture - HVT Site 1
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299337
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Final Assessment Report for Renewal
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299343
Author
Spanish Agency of Medicines and Medical Devices
Title
Acceptance of Notification ES/V/0264/001/IAin/006
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299394
Author
Renz KG, Islam AFMF, Cooke J , Clarke N , Cheetham BF et al
Title
Pathotyping of Australian isolates of Mareks disease virus and association of pathogenicity with meq gene polymorphism
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299363
Author
Ceva-Phylaxia Co Ltd
Title
Complementing Validation of a PCR Method
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302063
Author
Not Identified
Title
Steps of Manufacture - HVT Site 2
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299378
Author
Ceva Phylaxia Co Ltd
Title
Efficacy of Cevac MD HVT vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299355
Author
Ceva-Phylaxia Co Ltd
Title
serum Certificates of Analysis/Suitability
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299332
Author
R Banks
Title
Cevac MD HVT DEtailed and Critical Summary on Part 3 Efficacy Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299349
Author
Ceva-Phylaxia Co Ltd
Title
SPF flock test reports
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299338
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Quality Expert Statement
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299395
Author
Ceva Phylaxia
Title
Reg Status and sales data
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299392
Author
Dunn, J.R. and Gimeno, I.M.
Title
Current Status of Marek's Disease in the United States and Worldwide Based on a Questionaire Survey
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
300099
Author
Ceva-Phylaxia Co Ltd
Title
HVT Import Permit Application
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299366
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF THE PCR.BASED METHOD
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299372
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAF'ETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299329
Author
European Union member states
Title
Current Marketing Authorisations
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299335
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Day 190 Assessment of the day Day 170 responses to the Day 150 CLOQ
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299358
Author
Ceva-Phylaxia Co Ltd
Title
Validation of the Sterility Test
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299381
Author
Ceva Phylaxia Co Ltd
Title
Efficacy of CEVAC MD HVT vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299398
Author
Australian Pesticides and Veterinary Medicines Authority
Title
PAA advice and agreement
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299389
Author
Ceva Animal Health
Title
Letter of Authority
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299346
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Materials Listed in PhEur Certificates of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299326
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Part 2 Chemical, Pharmaceutical and Biological/Microbiological Information (Quality)
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299375
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299369
Author
Ceva-Phylaxia Co Ltd
Title
OVERDOSE SAFETY
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

151322
Product/Active constituent Name

Application Product Name

Cell-associated live Marek’s disease virus (MDV) serotype 1, strain CVI-988

Application details

Product name:

Cell-associated live Marek’s disease virus (MDV) serotype 1, strain CVI-988

Product number:

96952

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of an 800pfu/dose Marek's disease virus serotype 1, strain CVI988 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens.

Description of data provided:

Data no
302050
Author
Ceva-Phylaxia Co Ltd
Title
GENETIC IDENTIFICATION OF Rispens (MDV serotype)
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302021
Author
Ceva-Phylaxia Co Ltd
Title
Rispens (MDV Serotyope 1) EU MSV Certificate of Analysis
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302051
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens working seed virus WSV Certificate of Analysis
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

151323
Product/Active constituent Name

Application Product Name

Cevac MD Rispens

Application details

Product name:

Cevac MD Rispens

Product number:

96953

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of an 800pfu/dose Marek's disease virus serotype 1, strain CVI988 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens.

Active constituents:

Active constituent name
96952 - Cell-associated live Marek’s disease virus (MDV) serotype 1, strain CVI-988

Description of data provided:

Data no
297031
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF THE STERILITY TEST
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297054
Author
Ceva Phylaxia Co Ltd
Title
VALIDATION OF A REAL.TIME QUANTITATIVE PCR ASSAY
Study date
2013
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297037
Author
Ceva-Phylaxia Co Ltd
Title
Validation of PGR-based methods
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297020
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Materials isted in PhEur SPF flock testing
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297043
Author
Ceva-Phylaxia Co Ltd
Title
RESIDUAL PATHOGENICITY TEST OF THE MSV
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302069
Author
Not Identified
Title
Steps of Manufacture - MD Rispens Site 2
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297014
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD Rispens DAY 190 RMS ASSESSMENT OF THE DAY 170 APPLICANT`S RESPONSE TO THE DAY 150 CONSOLIDATED LIST OF QUESTIONS
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297051
Author
Ceva-Phylaxia Co Ltd
Title
Complementary MD efficacy test of V075 vaccine
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297057
Author
Bioproperties Pty Ltd
Title
Justification for waiving of local field trials.
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297040
Author
Ceva-Phylaxia Co Ltd
Title
STABILITY STUDY OF CEVAC MD RISPENS VACCINE
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297034
Author
Ceva-Phylaxia Co Ltd
Title
Validation Report of a PCR Method
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297017
Author
Ceva-Phylaxia Co Ltd
Title
List pf Post Authorization Submissions
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297023
Author
Free University Berlin Institute of Poultry Diseases
Title
Validation of an ELISA
Study date
2005
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297003
Author
Ceva-Phylaxia Co Ltd
Title
Summary of Product Characteristics
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297011
Author
R Banks
Title
Cevac MD Rispens Detailed and Critical Summary on Part 4 Efficacy Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297060
Author
Ceva Phylaxia Co Ltd
Title
Registration Status and Sales Data
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297029
Author
Ceva-Phylaxia Co Ltd
Title
Serum Certificates of Suitability/Analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297035
Author
Ceva-Phylaxia Co Ltd
Title
Validation Report of PCR
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297018
Author
Ceva-Phylaxia Co Ltd
Title
Ampule Specifications
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297049
Author
Ceva-Phylaxia Co Ltd
Title
EFFICACY OF V075 VACCINE
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297061
Author
Bioproperties Pty Ltd
Title
Executive Summary: Item 2 Cevac MD Rispens
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302067
Author
Not Identified
Title
Cevac MD Rispens Manufacturing Flowchart
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297006
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens PART 3 Safety Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297012
Author
Spanish Agency of Medicines and Medical Devices
Title
PRELIMINARY ASSESMENT REPORT
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297032
Author
Ceva-Phylaxia Co Ltd
Title
Monoclonal antibody specificity test
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297055
Author
Ceva Animal Health
Title
Letter of Authority
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297038
Author
Ceva-Phylaxia Co Ltd
Title
REPORT ON THE VALIDATION OF THE PCR.BASED METHOD
Study date
2013
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302070
Author
Not Identified
Title
Steps of Manufacture - MD Rispens Site 3
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297046
Author
Ceva-Phylaxia Co Ltd
Title
INCREASE IN VIRULENCE TEST OF THE MSV
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297015
Author
Ceva Sante Animale
Title
CEVAC RISPENS PHARMACOVIGILANCE REPORT
Study date
2024
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297052
Author
Ceva-Phylaxia Co Ltd
Title
FIELD SAFETY AND EFFICACY TRIAL OF V075 VACCINE
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297009
Author
R Banks
Title
Cevac MD Rispens Detailed and Critical Summary on Part 2 Quality Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297058
Author
Dunn JR and Gimeno IM
Title
Current Status of Marek's Disease in the United States and Worldwide Based on a Questionnaire Survey
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
297033
Author
Ceva-Phylaxia Co Ltd
Title
VALIDITATION OF THE TITRATION METHOD
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297041
Author
Ceva-Phylaxia Co Ltd
Title
In use stability study of Cevac MD Rispens vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297047
Author
Ceva-Phylaxia Co Ltd
Title
INCREASE IN VIRULENCE TEST OF THE MSV
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297024
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Material not listed in PhEur Certificates of Analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297004
Author
Ceva-Phylaxia Co Ltd
Title
Label and Leaflet
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297053
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy test
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297010
Author
R Banks
Title
Cevac MD Rispens Detailed and Critical Summary on Part 3 Safety Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297030
Author
Ceva-Phylaxia Co Ltd
Title
Serum Certificates of Suitability/Analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297044
Author
Ceva-Phylaxia Co Ltd
Title
SPREAD TEST OF V075 VACCINE
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297021
Author
Ceva-Phylaxia Co Ltd
Title
Technology Transfer Qualification Summary Report
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297050
Author
Ceva-Phylaxia Co Ltd
Title
FIELD SAFETY AND EFFICACY TRIAL OF V075 VACCINE
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297013
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD Rispens DAY 120 RMS ASSESSMENT OF THE APPLICANT'S RESPONSE TO THE DAY 105 CONSOLIDATED LIST OF QUESTIONS
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302068
Author
Not Identified
Title
Steps of Manufacture - MD Rispens Site 1
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297007
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens PART 4 Efficacy documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297056
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Certificate of Manufacture (Approved GMP)
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297039
Author
Ceva-Phylaxia Co Ltd
Title
Batch Release Certificates
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297022
Author
Ceva-Phylaxia Co Ltd
Title
SPF Flock test results
Study date
2022
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297045
Author
Ceva-Phylaxia Co Ltd
Title
SPREAD, SHED AND DISSEMINATION STUDY OF THE MSV
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297016
Author
National Food Chain Safety Office
Title
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297059
Author
Renz KG, Cooke J, Clarke N, Cheetham BF, Hussain Z, Islam AFMF, Tannock GA and Walkden-Brown SW
Title
Pathotyping of Australian isolates of Mareks disease virus and association of pathogenicity with meq gene polymorphism
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
297008
Author
European Union Member States
Title
Marketing Authorisations
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297028
Author
Ceva-Phylaxia Co Ltd
Title
CoA Origin statement/Irradiation certificate
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297036
Author
Ceva-Phylaxia Co Ltd
Title
Validation of a PCR Method
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297042
Author
Ceva-Phylaxia Co Ltd
Title
SAFETY TEST OF V075 VACCINE
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297048
Author
Ceva-Phylaxia Co Ltd
Title
EFFICACY OF V075 VACCINE
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297019
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Material listed in PhEur Certificates of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297062
Author
Australian Pesticides and Veterinary Medicines Authority
Title
62 Rispens PAA and Agreement
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302066
Author
DAFF
Title
MD Rispens Import Permit Application
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297005
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens Part 2 CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY)
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

152564
Product/Active constituent Name

Application Product Name

Ferric subsulfate

Application details

Product name:

Ferric subsulfate

Active name:

Ferric subsulfate

Applicant Name:

PHEBRA PTY LTD

Application purpose and description of use:

Approval of ferric subsulphate for use in veterinary chemical products.

Description of data provided:

Data no
303347
Author
Not Identified
Title
Ferric subsulfate CofA
Study date
31.01.2023
Authorising party
Applicant
Auth party contact address
19 Orion Road Lane Cove West Australia
Data no
303348
Author
Not Identified
Title
USP monograph Ferric subsulfate
Study date
2013
Authorising party
Applicant
Auth party contact address
19 Orion Road Lane Cove West Australia
Date

Application Date

Application No

Application Number

152588
Product/Active constituent Name

Application Product Name

topramezone

Application details

Product name:

topramezone

Active name:

topramezone

Applicant Name:

WEIFANG NUCHLOR CHEMICAL CO., LTD.

Application purpose and description of use:

Approval of Topramezone for use in agricultural chemical products.

Description of data provided:

Data no
304239
Author
Bioagri Laboratorios Ltda
Title
Analytical method validation and content of Dichloromethane Dimethylformamide, Methanol and Toluene in Topramezone Technical
Study date
2023/12/11
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
304231
Author
Weifang Nuchlor Chemical Co., Ltd
Title
6 The Statement of Batch Size of Topramezone Technical
Study date
2023/3/15
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
304228
Author
Weifang Nuchlor Chemical Co., Ltd.
Title
3 Manufacture Process of Topramezone Technical
Study date
2024/12/12
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
304229
Author
Weifang Nuchlor Chemical Co., Ltd.
Title
4 Registration Data of Topramezone Technical
Study date
2024/12/12
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
304227
Author
Weifang Nuchlor Chemical Co., Ltd.
Title
2 Declaration of Composition of Topramezone Technical
Study date
2024/12/12
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
304230
Author
WEIFANG NUCHLOR CHEMICAL CO., LTD.
Title
5 Impurity Justification of Topramezone Technical
Study date
2024/12/12
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Data no
304238
Author
Bioagri Laboratorios Ltda
Title
Qualitative and Quantitative Profile of Topramezone Technical (Five Batch Analysis)
Study date
2026
Authorising party
Applicant
Auth party contact address
EAST OF LINGANG RD & SOUTH LIAOHEXIER ST HAIHUA INDUSTRY PARK, BINHAI ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, WEIFANG CITY People's Republic of China
Date

Application Date

Application No

Application Number

152647
Product/Active constituent Name

Application Product Name

Farmalinx All-Star Hose-On Insecticide and Fertiliser

Application details

Product name:

Farmalinx All-Star Hose-On Insecticide and Fertiliser

Product number:

97291

Applicant Name:

FARMALINX PTY LTD

Application purpose and description of use:

Registration of a 4 g/L chlorantraniliprole ready to use (AL) product for control of major pests in turf.

Reference details:

90097 - Farmalinx All-Star Turf Insecticide
91903 - ACELEPRYN GR Lawn Grub and Army Worm Control
91647 - ACELEPRYN LAWN GRUB AND ARMY WORM CONTROL
63085 - ACELEPRYN TURF INSECTICIDE

Description of data provided:

Data no
304482
Author
Anon
Title
Reference product 3 label
Study date
12 July 2025
Authorising party
Public
Auth party contact address
-
Data no
304474
Author
Anon
Title
Raw Material specifications
Study date
7 July 2025
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304477
Author
Yarnton A.
Title
Method Validation for the determination of chlorantraniliprole in a ready to use solution
Study date
21 December 2023
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304480
Author
Farmalinx Pty Ltd
Title
Reference product 1 label
Study date
12 July 2025
Authorising party
Public
Auth party contact address
-
Data no
304483
Author
Harvey S, Gillmore, J
Title
Evaluation of Farmalinx Insecticides for the Control of Turf Insects
Study date
12 July 2025
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304475
Author
Ysibouklis, C.
Title
Certificate of Analysis - Storage
Study date
1 September 2025
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304484
Author
Anon
Title
Component SDS
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304478
Author
Farmalinx Pty Ltd
Title
Part 8 Efficacy
Study date
12 July 2025
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304481
Author
Anon
Title
Reference product 2 label
Study date
12 July 2025
Authorising party
Public
Auth party contact address
-
Data no
304479
Author
Farmalinx Pty Ltd
Title
Proposed RLP
Study date
25 March 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304476
Author
Yarnton, A
Title
Certificate of Analysis - Storage 2
Study date
21 December 2023
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
304473
Author
Anonymous
Title
The formulation of a ready-to-use home garden insecticide containing Chlorantraniliprole
Study date
January 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Date

Application Date

Application No

Application Number

152644
Product/Active constituent Name

Application Product Name

PROTEC PLUS SPRAY ADJUVANT

Application details

Product name:

PROTEC PLUS SPRAY ADJUVANT

Product number:

49685

Applicant Name:

GREVILLIA AG PTY. LIMITED

Application purpose and description of use:

Variation of product registration and label approval to include an extended pack size range and update to the Labelling Code.

Reference details:

84526 - BioAAid MSO SPRAY ADJUVANT
Date

Application Date

Application No

Application Number

152713
Product/Active constituent Name

Application Product Name

Metsulf 600 Herbicide

Application details

Product name:

Metsulf 600 Herbicide

Product number:

65529

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Variation of product registration and label approval to increase the pack size range.

Reference details:

55191 - CONQUEST METSULFURON 600 WG HERBICIDE
84856 - Agrocn Metsulfuron 600 WG Herbicide
Date

Application Date

Application No

Application Number

152511
Product/Active constituent Name

Application Product Name

Kenso Agcare Caimen 480 EC Herbicide

Application details

Product name:

Kenso Agcare Caimen 480 EC Herbicide

Applicant Name:

KENSO CORPORATION (M) SDN. BHD.

Application purpose and description of use:

Registration of 480 g/L Clomazone in the form of emulsifiable concentrate for the control of certain annual grasses in rice and certain annual broadleaf weeds in cucurbits, green beans, navy beans, poppies, potatoes and tobacco as per directions for use table.
Date

Application Date

Application No

Application Number

152631
Product/Active constituent Name

Application Product Name

MENNO FLORADES DISINFECTANT

Application details

Product name:

MENNO FLORADES DISINFECTANT

Product number:

92415

Applicant Name:

Menno Chemie-Vertrieb GMBH

Application purpose and description of use:

Variation of product registration and label approval to increase the pack size range to 1 - 1000 L
Date

Application Date

Application No

Application Number

152607
Product/Active constituent Name

Application Product Name

CLOTHIANIDIN

Application details

Product name:

CLOTHIANIDIN

Active name:

CLOTHIANIDIN

Applicant Name:

EUROCHEM PTY. LTD.

Application purpose and description of use:

Application for a new source of the currently approved product, CLOTHIANIDIN 95% Technical, for use in agricultural chemical products.

Description of data provided:

Data no
304193
Author
Ania Yarnton
Title
Part 2.2 - Appendix 4 - ACS-1715426-BA
Study date
2/10/2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304190
Author
Ania Yarnton
Title
Part 2.2 - Appendix 1B - ACS1715426-BA
Study date
2/10/2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304188
Author
unknown
Title
Part 2.2 - Chemistry and Manufacture Dossier for the Registration of a New Source of a Technical Grade Active Constituent - CLOTHIANIDIN - PGR-0750-2 - V1
Study date
27/7/2025
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304194
Author
unknown
Title
Part 2.2 - Appendix 5 - Manufacture of Clothianidin Active Constituent ??? V1
Study date
5/7/2025
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304191
Author
Joshua Dalton
Title
Part 2.2 - Appendix 2 - Impurity profile of Clothianidin technical grade material - ACS-IPR-068
Study date
7/10/2020
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304192
Author
Joshua Dalton
Title
Part 2.2 - Appendix 3 - Method Validation for the determination of clothianidin in technical material (TC) - ACS-VR-227-3
Study date
7/10/2020
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304189
Author
unknown
Title
Part 2.2 - Appendix 1A - Certificate of Analysis
Study date
2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304195
Author
unknown
Title
Part 2.2 - Appendix 6 - DoC Calculation Table for Impurity analysis of 5 Production Batches of CLOTHIANIDIN TECH
Study date
20/7/2025
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Date

Application Date

Application No

Application Number

152391
Product/Active constituent Name

Application Product Name

Sulfoxaflor

Application details

Product name:

Sulfoxaflor

Active name:

Sulfoxaflor

Applicant Name:

Chia Yi Chemical Industry Co., Ltd.

Application purpose and description of use:

Approval of sulfoxaflor for use in agricultural chemical products.
Date

Application Date

Application No

Application Number

152411
Product/Active constituent Name

Application Product Name

ARGUS 100 Insect Growth Regulator

Application details

Product name:

ARGUS 100 Insect Growth Regulator

Applicant Name:

Shanghai Broco Chemicals Co., Ltd.

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.
Date

Application Date

Application No

Application Number

152455
Product/Active constituent Name

Application Product Name

DURENTIS 200 SC INSECTICIDE

Application details

Product name:

DURENTIS 200 SC INSECTICIDE

Product number:

97242

Applicant Name:

2022 ENVIRONMENTAL SCIENCE AU PTY LTD

Application purpose and description of use:

Registration of a 200 g/L SC chlorantraniliprole product for the control of African Black Beetle, Argentine Stem Weevil, Argentinian Scarab, Billbugs and other insect pests in turf.

Reference details:

61519 - CORAGEN INSECTICIDE
63085 - ACELEPRYN TURF INSECTICIDE

Description of data provided:

Data no
303675
Author
2022 ENVIRONMENTAL SCIENCE AU PTY LTD
Title
Part 8 Efficacy and Safety
Study date
2026
Authorising party
Applicant
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
303672
Author
S. Salter
Title
Consent to use of Chlorantraniliprole protected information for Environmental Science AU Pty Ltd Durentis 200SC Insecticide Registration
Study date
12 December 2025
Authorising party
FMC AUSTRALASIA PTY LTD
Auth party contact address
Building B, 12 Julius Avenue, North Ryde, NSW 2113, Australia
Data no
303673
Author
S. Salter
Title
Manufacturer???s Declaration for Durentis 200SC Insecticide
Study date
12 December 2025
Authorising party
FMC AUSTRALASIA PTY LTD
Auth party contact address
Building B, 12 Julius Avenue, North Ryde, NSW 2113, Australia
Data no
303676
Author
FMC Corporation
Title
Coragen Insect Control Label
Study date
2020
Authorising party
Applicant
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
303674
Author
2022 ENVIRONMENTAL SCIENCE AU PTY LTD
Title
EXECUTIVE SUMMARY
Study date
2025
Authorising party
Applicant
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Date

Application Date

Application No

Application Number

152507
Product/Active constituent Name

Application Product Name

Aurugard Disinfectant

Application details

Product name:

Aurugard Disinfectant

Product number:

97264

Applicant Name:

AURUM TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a 100 g/L quaternary ammonium compound soluble concentrate product for use as a broad spectrum disinfectant in poultry, pig, dairy and vegetable farms.

Reference details:

59493 - GROWERS VIRUSAN QT BROAD-SPECTRUM DISINFECTANT
61658 - VIROGARD SANITISER
82652 - AGRIGUARD QUAT SANITISER
Date

Application Date

Application No

Application Number

152572
Product/Active constituent Name

Application Product Name

Bainbridge Bait Pellets Rodenticide

Application details

Product name:

Bainbridge Bait Pellets Rodenticide

Product number:

87659

Applicant Name:

BAINBRIDGE PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to vary the formulation, add packs and vary the Relevant Label Particulars.

Description of data provided:

Data no
304176
Author
Anon
Title
Formulation details
Study date
19 December 2025
Authorising party
Animal Control Products Ltd
Auth party contact address
408 HEADS ROAD, WHANGANUI 4501, New Zealand
Data no
304177
Author
APVMA
Title
s45A Notice Supension - Bainbridge Pty Ltd
Study date
19 December 2025
Authorising party
Applicant
Auth party contact address
26 Avatonbell Drive Luscombe Australia
Date

Application Date

Application No

Application Number

152609
Product/Active constituent Name

Application Product Name

Surefire Buprofezin 440 Insecticide

Application details

Product name:

Surefire Buprofezin 440 Insecticide

Applicant Name:

PCT HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 440 g/L suspension concentrate SC product for control of insect pests in fruit crops.
Date

Application Date

Application No

Application Number

152587
Product/Active constituent Name

Application Product Name

Imidacloprid

Application details

Product name:

Imidacloprid

Active name:

Imidacloprid

Applicant Name:

JIANGSU AGROCHEM LABORATORY CO LTD

Application purpose and description of use:

Approval of Imidacloprid for use in agricultural chemical products.

Description of data provided:

Data no
304182
Author
Yonghui Sun
Title
Method of Manufacture of Imidacloprid Technical
Study date
20/05/2024
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304180
Author
Wendy Wang W.
Title
Five Batches Analysis Conclusion
Study date
16/03/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304183
Author
Carrie Zhang
Title
Declaration of Composition
Study date
16/03/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304184
Author
Carrie Zhang
Title
Data list of Imidacloprid TC
Study date
23/03/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304181
Author
Wendy Wang W.
Title
Five Batches Analysis of Imidacloprid Technical
Study date
16/03/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Date

Application Date

Application No

Application Number

152476
Product/Active constituent Name

Application Product Name

VAXSAFE ND VACCINE (LIVING)

Application details

Product name:

VAXSAFE ND VACCINE (LIVING)

Product number:

59142

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Variation of product registration and label approval to extend the shelf life.

Active constituents:

Active constituent name
56035 - NEWCASTLE DISEASE STRAIN V-4 VIRUS
Active constituent name
93016 - Newcastle Disease Virus Vaccine strain V4

Description of data provided:

Data no
302348
Author
Bioproperties Pty Ltd
Title
Item 14 Variation for Shelf Life Extension Vaxsafe ND Vaccine
Study date
February 2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302349
Author
Bioproperties Pty Ltd
Title
Vaxsafe ND (1,000 dose and 20,000 dose) Long Term Stability to extend shelf life when filled in 10 ml vials
Study date
November 2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

152554
Product/Active constituent Name

Application Product Name

Agro-Essence Flutrixa Duo Seed Treatment

Application details

Product name:

Agro-Essence Flutrixa Duo Seed Treatment

Product number:

97271

Applicant Name:

THEYES MANAGEMENT PTY LTD

Application purpose and description of use:

Registration of a 25 g/L Flutriafol and 4 g/L Cypermethrin Flowable Seed Treatment (FS) to protect against smuts and bunt in wheat, barley, oats and triticale

Reference details:

89652 - TITAN FLUTRIAFOL 25/CYPERMETHRIN 4 LIQUID SEED DRESSING
63205 - ACCENSI FLUTRIAFOL 25/CYPERMETHRIN 4 LIQUID SEED DRESSING
60144 - VETERAN C SEED DRESSING FLOWABLE
59324 - CONQUEST VIBRANT 25C LIQUID SEED DRESSING
30255 - VINCIT C SEED DRESSING LIQUID
45861 - VINCIT C SEED DRESSING FLOWABLE

Active constituents:

Active constituent name
56861 - FLUTRIAFOL
Active constituent name
51810 - CYPERMETHRIN
Active constituent name
58156 - CYPERMETHRIN

Description of data provided:

Data no
304030
Author
Anon
Title
Specifications of Flutriafol 25 g/L + Cypermethrin 4 g/L ES
Study date
26/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304024
Author
Anon
Title
SDS excipients
Study date
2024
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304033
Author
Shawantika Chakraborty
Title
ACUTE DERMAL TOXICITY STUDY OF FLUTRIAFOL 25 G/L + CYPERMETHRIN 4 G/L ES IN WISTAR RATS
Study date
16/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304027
Author
Anon
Title
CoA Cypermethrin
Study date
24/05/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304036
Author
Jogendra Pratap Singh
Title
ACUTE EYE IRRITATION/CORROSION STUDY OF FLUTRIAFOL 25 G/L + CYPERMETHRIN 4 G/L ES IN NEW ZEALAND WHITE RABBIT
Study date
16/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304028
Author
Anon
Title
CoA Cypermethrin
Study date
10/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304022
Author
Anon
Title
SDS Cypermethrin
Study date
08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304039
Author
Anon
Title
Crop safety of Wheat, Barley, Oats and Triticale seedlings following seed treatment
Study date
11/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304025
Author
Anon
Title
SDS product
Study date
08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304031
Author
K. Ayyavoo
Title
Accelerated Storage Stability Study of Flutriafol 25 g/L + Cypermethrin 4 g/L ES
Study date
26/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304042
Author
Anon
Title
Part 8
Study date
2026
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304026
Author
Anon
Title
CoA Flutriafol
Study date
15/03/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304037
Author
Jogendra Pratap Singh
Title
SKIN SENSITIZATION STUDY OF FLUTRIAFOL 25 G/L + CYPERMETHRIN 4 G/L ES IN GUINEA PIGS BY GUINEA PIG MAXIMIZATION TEST METHOD
Study date
16/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304023
Author
Anon
Title
SDS Flutriafol
Study date
08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304040
Author
Anon
Title
Evaluate Agro-Essence Flutriafol & Cypermethrin Seed Dressing Liquid for the Control of Stored Pests in Wheat.
Study date
20/01/2026
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304034
Author
Ritesh Kumar
Title
ACUTE INHALATION TOXICITY STUDY OF FLUTRIAFOL 25 G/L + CYPERMETHRIN 4 G/L ES IN WISTAR RATS
Study date
16/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304032
Author
Shawantika Chakraborty
Title
ACUTE ORAL TOXICITY STUDY OF FLUTRIAFOL 25 G/L + CYPERMETHRIN 4 G/L ES IN WISTAR RATS BY ACUTE TOXIC CLASS METHOD
Study date
16/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304035
Author
Ritesh Kumar
Title
ACUTE DERMAL IRRITATION/CORROSION STUDY OF FLUTRIAFOL 25 G/L + CYPERMETHRIN 4 G/L ES IN NEW ZEALAND WHITE RABBIT
Study date
16/08/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304041
Author
Anon
Title
Evaluate Agro-Essence Flutriafol & Cypermethrin Seed Dressing for the Control of Diseases in Wheat.
Study date
06/02/2026
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304029
Author
Anon
Title
Manufacturing Process of Flutriafol 25 g/L + Cypermethrin 4 g/L ES
Study date
30/07/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
304038
Author
Anon
Title
Part 3
Study date
09/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia