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
148038
Product/Active constituent Name
Application Product Name
Quantum Diquat 200 SL Herbicide
Application Date
Application Number
148038
Application Product Name
Quantum Diquat 200 SL Herbicide
Application details
Product name:
Quantum Diquat 200 SL Herbicide
Product number:
96055
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 200g/L Diquat present as diquat dibromide monohydrate Soluble concentrate (SL) product for pre-harvest crop desiccation and the control of a wide range of broadleaf weeds in certain crops as per Directions for Use.
Reference details:
58411 - IMTRADE DIQUAT 200 NON-RESIDUAL HERBICIDE
Active constituents:
Active constituent name
56808 - DIQUAT DIBROMIDE MANUFACTURING CONCENTRATE
Active constituent name
56655 - DIQUAT DIBROMIDE MANUFACTURING CONCENTRATE
Active constituent name
88034 - Diquat dibromide manufacturing concentrate
Date
Application Date
Application No
Application Number
148031
Product/Active constituent Name
Application Product Name
Quantum Abamectin 18 EC Insecticide
Application Date
Application Number
148031
Application Product Name
Quantum Abamectin 18 EC Insecticide
Application details
Product name:
Quantum Abamectin 18 EC Insecticide
Product number:
96048
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 18g/L Abamectin Emulsifiable concentrate (EC) product for the control of pest mites and native budworm on cotton. For the control of pest mites on pears, apples, capsicums, tomatoes, strawberries and ornamentals as specified in the directions for use table.
Reference details:
95365 - Sabakem Abamectin 18EC
Active constituents:
Active constituent name
44497 - ABAMECTIN
Active constituent name
69041 - ABAMECTIN
Date
Application Date
Application No
Application Number
148033
Product/Active constituent Name
Application Product Name
Quantum Glufosinate 200 SL Herbicide
Application Date
Application Number
148033
Application Product Name
Quantum Glufosinate 200 SL Herbicide
Application details
Product name:
Quantum Glufosinate 200 SL Herbicide
Product number:
96050
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 200g/LGlufosinate-ammonium soluble concentrate (SL) product for NON-RESIDUAL CONTROL OF BROADLEAF AND GRASS WEEDS IN VARIOUS SITUATIONS AS SPECIFIED IN THE DIRECTIONS FOR USE TABLE.
Reference details:
91138 - Sabakem Glufosinate 200 Herbicide
Active constituents:
Active constituent name
85386 - Glufosinate-ammonium
Active constituent name
83347 - Glufosinate-ammonium
Date
Application Date
Application No
Application Number
147648
Product/Active constituent Name
Application Product Name
Inactivated Leptospira interrogans serogroup Australis and serovar Bratislava strain 16785
Application Date
Application Number
147648
Application Product Name
Inactivated Leptospira interrogans serogroup Australis and serovar Bratislava strain 16785
Application details
Product name:
Inactivated Leptospira interrogans serogroup Australis and serovar Bratislava strain 16785
Product number:
95937
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of an inactivated leptospirosis vaccine for dogs, containing Leptospira interrogans serogroup and serovar Canicola, Leptospira interrogans serogroup and serovar Icterohaemorrhagiae, Leptospira interrogans serogroup and serovar Grippotyphosa and Leptospira interrogans serogroup Australis and serovar Bratislava, in conjunction with approval of the four Leptospira antigens.
Description of data provided:
Data no
285447
Title
Validation Study 19.0027r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285467
Title
Technical Document - Justification for variation
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285453
Title
Master seeds - specfications and CoAs - L. australis
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285464
Title
Certificates of Analysis and seroneutralisation assessment reports - Leptospira australis - Study 13.0070r
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285473
Title
Updated manufacturing process and test method documentation and supporting inactivation kinetic and potency assay study reports - 2B2-active-ingredients-updated
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285470
Title
Certificate of conformity
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285444
Title
Validation study 19.0026.R
Study date
2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285450
Title
Validation Study 18.0549r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285465
Title
Updated method 200851
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285445
Title
Validation study 2021-1299r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285479
Title
Inactivation kinetic studies - Study number 18.0205r
Study date
2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285448
Title
Validation study 2021-1335
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285468
Title
Part 2B Manufacturing method - L australis
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285463
Title
Certificates of Analysis and seroneutralisation assessment reports - Leptospira australis
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285474
Title
Updated manufacturing process and test method documentation and supporting inactivation kinetic and potency assay study reports - 2b3 Updated
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285480
Title
Sensitivity of inactivation method - Study Number 17.0125r
Study date
2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285469
Title
Part 2B flow chart
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285475
Title
Updated manufacturing process and test method documentation and supporting inactivation kinetic and potency assay study reports - 2d2 update
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285472
Title
Updated manufacturing process and test method documentation and supporting inactivation kinetic and potency assay study reports - Study 2021-1671
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147649
Product/Active constituent Name
Application Product Name
Inactivated Leptospira interrogans serogroup and serovar Grippotyphosa strain Grippo Mal 1540
Application Date
Application Number
147649
Application Product Name
Inactivated Leptospira interrogans serogroup and serovar Grippotyphosa strain Grippo Mal 1540
Application details
Product name:
Inactivated Leptospira interrogans serogroup and serovar Grippotyphosa strain Grippo Mal 1540
Product number:
95938
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of an inactivated leptospirosis vaccine for dogs, containing Leptospira interrogans serogroup and serovar Canicola, Leptospira interrogans serogroup and serovar Icterohaemorrhagiae, Leptospira interrogans serogroup and serovar Grippotyphosa and Leptospira interrogans serogroup Australis and serovar Bratislava, in conjunction with approval of the four Leptospira antigens.
Description of data provided:
Data no
285459
Title
Certificates of Analysis and seroneutralisation assessment reports - Leptospira grippotyphosa
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285443
Title
Validation Study 07.0541.R
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285451
Title
Validation study 19.0077r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285483
Title
Sensitivity of inactivation method - Study Number 07.0286r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285460
Title
Certificates of Analysis and seroneutralisation assessment reports - L . grippotyphosa - Study 13.0156r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285477
Title
Inactivation kinetic studies - Study number 09.0202r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285455
Title
Master seeds - specfications and CoAs - L. grippotyphosa
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285466
Title
Health monitoring report
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285446
Title
Validation study 06.0213r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147650
Product/Active constituent Name
Application Product Name
Inactivated Leptospira interrogans serogroup and serovar Icterohaemorrhagiae strain 16069
Application Date
Application Number
147650
Application Product Name
Inactivated Leptospira interrogans serogroup and serovar Icterohaemorrhagiae strain 16069
Application details
Product name:
Inactivated Leptospira interrogans serogroup and serovar Icterohaemorrhagiae strain 16069
Product number:
95939
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of an inactivated leptospirosis vaccine for dogs, containing Leptospira interrogans serogroup and serovar Canicola, Leptospira interrogans serogroup and serovar Icterohaemorrhagiae, Leptospira interrogans serogroup and serovar Grippotyphosa and Leptospira interrogans serogroup Australis and serovar Bratislava, in conjunction with approval of the four Leptospira antigens.
Description of data provided:
Data no
285461
Title
Certificates of Analysis and seroneutralisation assessment reports - Leptospira icterohaemorrhagiae
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285481
Title
Sensitivity of inactivation method - Study Number 07.0540r
Study date
2009
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285462
Title
Certificates of Analysis and seroneutralisation assessment reports - Leptospira icterohaemorrhagiae Study 13.0154r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285456
Title
Master seeds - specfications and CoAs - L. icterohaemorrhagiae
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285478
Title
Inactivation kinetic studies - Study 10.0027r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285449
Title
Validation study 18.0550r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147651
Product/Active constituent Name
Application Product Name
Inactivated Leptospira interrogans serogroup and serovar Canicola strain 16070
Application Date
Application Number
147651
Application Product Name
Inactivated Leptospira interrogans serogroup and serovar Canicola strain 16070
Application details
Product name:
Inactivated Leptospira interrogans serogroup and serovar Canicola strain 16070
Product number:
95940
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of an inactivated leptospirosis vaccine for dogs, containing Leptospira interrogans serogroup and serovar Canicola, Leptospira interrogans serogroup and serovar Icterohaemorrhagiae, Leptospira interrogans serogroup and serovar Grippotyphosa and Leptospira interrogans serogroup Australis and serovar Bratislava, in conjunction with approval of the four Leptospira antigens.
Description of data provided:
Data no
285482
Title
Sensitivity of inactivation method - Study Number 09.0461r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285476
Title
Inactivation kinetic studies - Study 09.0564r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285457
Title
Certificates of Analysis and seroneutralisation assessment reports - L canicola
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285471
Title
Updated 2B2
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285454
Title
Master seeds - specfications and CoAs - L. canicola
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285458
Title
Certificates of Analysis and seroneutralisation assessment reports - L canicola Study 14.0030r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
285452
Title
Validation study 19.0119r
Study date
2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147652
Product/Active constituent Name
Application Product Name
Protech Lepto 4 Inactivated Vaccine for Dogs
Application Date
Application Number
147652
Application Product Name
Protech Lepto 4 Inactivated Vaccine for Dogs
Application details
Product name:
Protech Lepto 4 Inactivated Vaccine for Dogs
Product number:
95941
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of an inactivated leptospirosis vaccine for dogs, containing Leptospira interrogans serogroup and serovar Canicola, Leptospira interrogans serogroup and serovar Icterohaemorrhagiae, Leptospira interrogans serogroup and serovar Grippotyphosa and Leptospira interrogans serogroup Australis and serovar Bratislava, in conjunction with approval of the four Leptospira antigens.
Active constituents:
Active constituent name
95937 - Inactivated Leptospira interrogans serogroup Australis and serovar Bratislava strain 16785
Active constituent name
95938 - Inactivated Leptospira interrogans serogroup and serovar Grippotyphosa strain Grippo Mal 154
Active constituent name
95939 - Inactivated Leptospira interrogans serogroup and serovar Icterohaemorrhagiae strain 16069
Active constituent name
95940 - Inactivated Leptospira interrogans serogroup and serovar Canicola strain 16070
Description of data provided:
Data no
284202
Title
Part 2C Production and control of starting materials
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298597
Title
Overview and structure of application
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284225
Title
Relevance of Leptospira challenge strains -eu21d975
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298574
Title
Method of manufacture of Lg antigen dated 06/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284156
Title
Updated Part 2F Batch to batch consistency
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298480
Title
Control test technique - 10036
Study date
2002
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298551
Title
Challenge study 15-0101-r
Study date
2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284179
Title
Serological evidence of exposure of healthy dogs to Leptospira in Sydney, New South Wales, Australia.
Study date
2024
Auth party contact address
-
Data no
284110
Title
A canine vaccine against Leptospira serovars Icterohaemorrhagiae, Canicola and Grippotyphosa provides cross protection against Leptospira serovar Copenhageni.
Study date
2020
Auth party contact address
-
Data no
298428
Title
Onset of immunity study 10-0021-r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284133
Title
Master seeds - specfications and CoAs
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298451
Title
Onset of immunity study 19-0005-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298474
Title
Field safety and efficacy study:10-0568-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298643
Title
Study to investigate virus clearance in BSA
Study date
2005
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298497
Title
CoA antigen batch 19LAUS6E05
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298620
Title
Control test technique - 001839
Study date
2001
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284196
Title
Responses to EMA List of Outstanding Issues
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298520
Title
Annex-5-17: List of label mock-ups
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298603
Title
APVMA-approved label Duramune C4
Study date
2025
Auth party contact address
-
Data no
298614
Title
Non-biological origin starting material - Buffer solution
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298511
Title
Part 2B: Description of manufacturing method summary
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298457
Title
Duration of immunity study 2020346-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284150
Title
Technical document - Justification for variation
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298557
Title
Comparison of Real-Time PCR Assays for Detection of Pathogenic Leptospira spp. in Blood and Identification of Variations in Target Sequences
Study date
2011
Auth party contact address
-
Data no
298537
Title
Onset and duration of protective immunity against clinical disease and renal carriage in dogs provided by a bi-valent inactivated leptospirosis vaccine
Study date
2009
Auth party contact address
-
Data no
298468
Title
Part 3: Table of Contents
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284142
Title
Test method 10036 validation study
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284216
Title
Booster efficacy study - 15.0075.r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298417
Title
Duration of immunity study 08-243-r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284116
Title
Duramune Adult C4 APVMA label
Study date
2018
Auth party contact address
-
Data no
298517
Title
Annex-5-22: Justification of new active ingredient
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298445
Title
Duration of immunity study 18-0180-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298494
Title
CoA antigen batch P3LIH6N36
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284236
Title
Onset of immunity studies - 18.0340.r, 09.0469.r, 19.0004.r, 10.0054.r, 19.0005.r and 10.0018.r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298425
Title
Onset of immunity study 10-0018-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298437
Title
2021-1335: Sterility test validation
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298531
Title
Responses to VMD LoQs
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298543
Title
Identity test results Lcop challenge strain
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298580
Title
Certificate of analysis for batch F95684
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298637
Title
Identification Lg
Study date
2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284122
Title
Nobivac L4 suspension for injection
Study date
2025
Auth party contact address
-
Data no
298488
Title
CoA batch 193265D5A21
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284173
Title
Part 2C Production and control of starting materials
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284222
Title
Field efficacy and safety study - 10.0568.r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284107
Title
Serovar Australis replaces serovar Copenhageni as the most common cause of canine leptospirosis in New South Wales, Australia.
Study date
2024
Auth party contact address
-
Data no
298431
Title
Duration of immunity study 10-0569-r
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284153
Title
Updated Part 2B Manufacturing method
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298477
Title
Target animal safety study 10-0492-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284130
Title
Validation studies
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298454
Title
Compatibility study 2020181-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284205
Title
Part 2B Description of manufacturing method - finished product
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298523
Title
Annex-5-9: GMP certificate for site 3
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298594
Title
APVMA-registered label for Protech C2i
Study date
2025
Auth party contact address
-
Data no
298600
Title
Bulk antigen certificates of analysis
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284182
Title
CVMP Opinion
Study date
7 November 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298500
Title
CoA antigen batch 1LC5Z46
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298617
Title
Control test technique - 000077
Study date
2001
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298623
Title
Control test technique - 10010
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284159
Title
19-0323-r - Final stability report
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298646
Title
Leptospirosis
Study date
2012
Auth party contact address
-
Data no
284136
Title
Pat 2G Stability tests
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298571
Title
CVMP opinion - WS2730
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298508
Title
Starting material specification-inactivant
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298414
Title
Duramune vaccines formulation and specifications
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298554
Title
Clinical test technique M5201R
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284193
Title
VMD Summary of Product Characteristics
Study date
August 2023
Auth party contact address
-
Data no
284199
Title
Responses to VMD List of Outstanding Issues
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298606
Title
Aluminium cap certificate of conformance
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298560
Title
Duration of immunity of a multivalent (DHPPi/L4R) canine vaccine against four Leptospira serovars
Study date
2013
Auth party contact address
-
Data no
284099
Title
Rapporteur's Assessment Report
Study date
7 November 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298460
Title
Qualitative and quantitative composition of Eurican freeze-dried attenuated live viral
vaccines
vaccines
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284119
Title
Control of canine leptospirosis in Europe: time for a change?
Study date
2010
Auth party contact address
-
Data no
284190
Title
CVMP public assessment report
Study date
15 February 2023
Auth party contact address
-
Data no
298514
Title
EU product leaflet
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284096
Title
Application Overview
Study date
27 February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284213
Title
Part 3 Safety documentation
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284239
Title
Detailed and critical summary (DACs) - Safety
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298563
Title
Certificates of analysis for La bulk antigen batches
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298491
Title
CoA antigen batch P2LG6V19
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298540
Title
Identity test results Li challenge strain
Study date
2007
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284139
Title
Updated dossier Part 2A - Conclusion
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284162
Title
Updated Part 2F3 of dossier, batch protocol template and updated vaccine batch release protocols
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284233
Title
Challenge model validation study - 14.0356.r
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298471
Title
Field safety study 10-0489-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298448
Title
2022-1999: Sterility test validation
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284113
Title
European consensus statement on leptospirosis in dogs and cats.
Study date
2015
Auth party contact address
-
Data no
298591
Title
CoAs for antigen batches manufactured 2024/5
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284219
Title
Filed safety and efficacy study - 10.0491.r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298640
Title
EU certificate of suitability BSA - 1
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296364
Title
Cellular and humoral immune responsiveness to inactivated Leptospira interrogans in dogs vaccinated with a tetravalent Leptospira vaccine.
Study date
2023
Auth party contact address
-
Data no
298577
Title
L3 formulation and closures dated 06/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298626
Title
Control test technique - 11000
Study date
2006
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298434
Title
Duration of immunity study 11-0146-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284170
Title
Inactivation kinetic studies
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284176
Title
Duramune C4 and C3 formulation and specifications
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298634
Title
Control test technique - 31513
Study date
2001
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298534
Title
WSAVA Guidelines for the vaccination of dogs and cats
Study date
2016
Auth party contact address
-
Data no
298583
Title
Part 2F: Batch consistency data for La bulk antigen
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284131
Title
Pharmacopoeial standard starting materials - Monographs and CoAs
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298455
Title
Duration of immunity study 2020182-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298526
Title
Annex-5-3: EU proof of establishment
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284108
Title
Leptospirosis is an emerging infectious disease of pig-hunting dogs and humans in north Queensland.
Study date
2020
Auth party contact address
-
Data no
298432
Title
Duration of immunity study 10-0570-r
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298549
Title
EU SPC draft including changes
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284177
Title
Protech C2i APVMA label
Study date
2013
Auth party contact address
-
Data no
284154
Title
Part 2C Production and control of starting materials
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298503
Title
Starting material specification-agar
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298618
Title
Control test technique - 000330
Study date
1999
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298641
Title
EU certificate of suitability BSA - 2
Study date
2007
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298572
Title
List of starting materials for L4 product dated 06/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298595
Title
Protech C2i formulation and specifications
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284137
Title
19-0323-r1 - Interim stability report
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284208
Title
Part 2D Control tests during production - active ingredients
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298449
Title
Onset of immunity study 19-0001-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284102
Title
Safety Update Report - Eurican CHPPi-L3
Study date
21 March 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298555
Title
Clinical findings in dogs diagnosed with leptospirosis in England
Study date
2021
Auth party contact address
-
Data no
298566
Title
Viral inactivation related to steam sterilisation of biological products
Study date
2012
Auth party contact address
-
Data no
298649
Title
Duration of immunity study 08-242-r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298601
Title
European Commission Decision on Eurican L4
Study date
2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298612
Title
Non-biological origin starting material - Solution 1
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284194
Title
VMD Public assessment report
Study date
August 2023
Auth party contact address
-
Data no
284200
Title
Additional challenge model documentation - 15.0052.r, 15.0101.r, 15.0268.r and 15.0442.r
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298463
Title
Formulation of Eurican Lmulti and Eurican L4 (eu21d976)
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284148
Title
Part 2B Manufacturing method and flow chart
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298509
Title
Starting material specification-water for injection
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284214
Title
Reproductive safety study - 10-0492-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298443
Title
Validation study 16-0018-r
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298609
Title
EP monograph - Glass containers for pharmaceutical use
Study date
2023
Auth party contact address
-
Data no
298586
Title
La antigen manufacture flowchart dated 07/24 draft
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284165
Title
Additional container closure information and updated documentation
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298492
Title
CoA antigen batch P2LG6X21
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284191
Title
European Commission Decision
Study date
31 March 2023
Auth party contact address
-
Data no
284240
Title
Part 2F Batch consistency - active ingredient CoAs
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298466
Title
Correlates of Vaccine-Induced Immunity
Study date
2008
Auth party contact address
-
Data no
298515
Title
EU product outer packaging label
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296359
Title
95941/147652 - Section 159(1)(a) Response
Study date
1 December 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284185
Title
EU variation dossier 2
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284234
Title
Rabisin compatibility studies -2020181, 12.0156.r and 14.0433.r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298423
Title
Onset of immunity study 09-0521-r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298472
Title
Field safety study 10-0490-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284220
Title
Field safety study - 10.0490.r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284114
Title
Updated ACVIM consensus statement on leptospirosis in dogs.
Study date
2023
Auth party contact address
-
Data no
298592
Title
Control test technique - 200703
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298578
Title
Technical Document vr00210647 - pH regulation of Leptospira serovars
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284128
Title
Container closure system
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296365
Title
Summary Update Report
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298529
Title
Part 2G: Stability data summary - updated
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298535
Title
Vacuolar hepatopathy in dogs: 336 cases (1993 2005)
Study date
2006
Auth party contact address
-
Data no
298629
Title
Control test technique - 11351
Study date
2002
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298635
Title
Control test technique - 200047
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284171
Title
Sensitivity of inactivation method
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298486
Title
CoA antigen batch 8LG6F06
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298621
Title
Control test technique - 002424
Study date
2003
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298598
Title
EMA-CVMP Opinion on VRA-0002
Study date
2024
Auth party contact address
-
Data no
298575
Title
Method of manufacture of Li antigen dated 06/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284105
Title
Letter of Authorisation
Study date
5 December 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284228
Title
Onset of immunity study - 15.0382.r
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298429
Title
Onset of immunity study 10-0054-r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298552
Title
Validation study 15-02608-r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284134
Title
Part 2F Batch to batch consistency
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298452
Title
Duration of immunity study 2019158-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284157
Title
Suitability of extraneous agent test methods - supporting references
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298475
Title
Field safety and efficacy study:12-0258-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298569
Title
Control tests on batches of finished product
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284111
Title
Expert Report
Study date
14 February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298546
Title
QPPV curriculum vitae
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298615
Title
Non-biological origin starting material - Solution 2
Study date
2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284145
Title
Health monitoring report
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284151
Title
Part 2A1 Qualitative and quantitative particulars of the constituents
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298506
Title
Starting material specification-ps80
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298512
Title
Part 2A: Qualitative and quantitative particulars overview
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284197
Title
Responses to VMD List of Outstanding Issues
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298558
Title
Zoonoses Report UK 2017
Study date
2017
Auth party contact address
-
Data no
298538
Title
Duration of immunity in dogs vaccinated against leptospirosis with a bivalent inactivated vaccine
Study date
2003
Auth party contact address
-
Data no
284237
Title
Safety study 19.0006.r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298420
Title
Onset of immunity study 09-0469-r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284168
Title
Part 2E Control tests on the finished product
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298489
Title
CoA batch 193265D5A32
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284211
Title
Part 2G Stability Tests - active ingredients and finished product
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298446
Title
Validation study 18-0339-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284188
Title
CVMP opinion and post-approval recommendation letter
Study date
15 February 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298469
Title
2022-2197: Sterility test validation
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298495
Title
CoA antigen batch 18LAUS6C03
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284125
Title
Eurican DAPPi composition and specifications
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296362
Title
Certificates of analysis - Media ingredients
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298532
Title
GB SPC draft with tracked changes
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284231
Title
Certificates of analysis
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298426
Title
Onset of immunity study 10-0019-r
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298589
Title
Flow chart and description for formulation, filling and packaging
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298638
Title
Identification Li, Lc and Lg
Study date
1994
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284217
Title
Field safety and efficacy study - 2019426.r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298440
Title
Compatibility study 15-0074-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284174
Title
User safety - Part 3 Safety Documentation
Study date
2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298483
Title
Part 2H: Other information
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298632
Title
Control test technique - 31503
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284106
Title
Declaration
Study date
14 February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298501
Title
Batch release specification
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284129
Title
Part 2B Description of manufacturing method
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298478
Title
Target animal safety study 19-0006-r
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284229
Title
Eurican DAPPi and DAP compatibility studies
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298547
Title
Increase in canine leptospirosis cases
Study date
28 February 2015
Auth party contact address
-
Data no
298624
Title
Control test technique - 10011
Study date
2000
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284206
Title
Part 2C Production and control of starting materials
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298524
Title
Annex-5-8: List of sites of manufacture
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298647
Title
Part 4: Table of Contents
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284183
Title
Appendix 3 - Safety & Efficacy Data Elements
Study date
27 February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298593
Title
CoA for batches of finished product
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284160
Title
Updated Part 2C2 MSB and WSB documentation, batch protocols and irradiation treatment validation report
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298570
Title
Variation assessment report - WS2730
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298461
Title
Analytical methods used in efficacy studies (eu21d974)
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298616
Title
Sterility test - 9CFR monograph
Study date
1991
Auth party contact address
-
Data no
298415
Title
Composition of batches used in clinical trials
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284146
Title
Updated batch release protocols
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284152
Title
Part 2B Description of the manufacturing method
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298553
Title
Compatibility study 15-0442-r
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284100
Title
Pharmacovigilance data - Eurican L4
Study date
28 November 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298507
Title
Starting material specification-purified water
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298607
Title
Certificates of analysis - stability batches
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298633
Title
Control test technique - 31512
Study date
2000
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284120
Title
Emerging leptospirosis in urban Sydney dogs: a case series (2017-2020).
Study date
2022
Auth party contact address
-
Data no
284189
Title
CVMP positive opinion summary
Study date
17 February 2023
Auth party contact address
-
Data no
298441
Title
Booster effect study 15-0075-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298490
Title
CoA antigen batch P1LIH6F29
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298564
Title
Isolations of Cache Valley Virus in Texas, 1981
Study date
1987
Auth party contact address
-
Data no
284140
Title
Biological ingredient suppliers
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298470
Title
Field safety study 10-0488-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298541
Title
Identity test results Lg challenge strain
Study date
2015
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284163
Title
Updated dossier Part 2G Stability Tests and stability batch CoAs
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284212
Title
Detailed and critical summary (DACs) - Efficacy
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298421
Title
Onset of immunity study 09-0470-r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298447
Title
Onset of immunity study 18-0340-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284232
Title
Responses to VMD List of Questions
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298627
Title
Control test technique - 11204
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284126
Title
Protech C4 and C3 formulation and specifications
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298427
Title
Onset of immunity study 10-0020-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298590
Title
Tests conducted on Leptospira seeds
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296363
Title
Import permit
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284169
Title
Biological materials - specifcations and CoAs
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298584
Title
La antigen manufacture flowchart dated 07/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298435
Title
Duration of immunity study 11-0147-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298484
Title
Part 2G: Stability data summary
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298533
Title
GB SPC draft including changes
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284226
Title
Formulation of Eurican Lmulti and Eurican L4 - eu21d976
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298550
Title
Validation study: 15-0052-r
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284132
Title
Non-pharmacopoeial starting materials - specifications and CoAs
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298573
Title
List of starting materials for L3 product dated 06/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284180
Title
CVMP Opinion
Study date
14 November 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298504
Title
Container - rubber stopper specification
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284203
Title
Part 2A Qualitative and quantitative particulars
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298527
Title
L australis identification
Study date
2015
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284109
Title
MAT cross-reactions or vaccine cross protection: retrospective study of 863 leptospirosis canine cases
Study date
2018
Auth party contact address
-
Data no
298498
Title
CoA antigen batch 0LC5X44
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298521
Title
Annex-5-9: GMP certificate for site 2
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298644
Title
SPC Eurican L4 suspension for injection
Study date
2022
Auth party contact address
-
Data no
284149
Title
Responses to List of Questions
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298450
Title
Onset of immunity study 19-0004-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298567
Title
Bunyavirus diseases of animals
Study date
2014
Auth party contact address
-
Data no
298604
Title
Aluminium cap specifciations
Study date
2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284103
Title
PAA written advice and project plan
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298613
Title
Starting material - medium preparation
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298458
Title
Multivariate analysis of the immune response to a vaccine as an alternative to the repetition of animal challenge studies for vaccines with demonstrated efficacy.
Study date
2017
Auth party contact address
-
Data no
298464
Title
Signalment Changes in Canine Leptospirosis between 1970 and 2009
Study date
2014
Auth party contact address
-
Data no
284097
Title
Appendix 2 - Chemistry and Manufacture Data Elements
Study date
27 February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298510
Title
Part 2C: production and control of starting materials summary
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284143
Title
Responses to EU List of Outstanding Issues
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298467
Title
EU SPC for Eurican Lmulti Suspension for injection
Study date
2022
Auth party contact address
-
Data no
298444
Title
Duration of immunity study 18-0179-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298561
Title
Viral Diseases
Study date
2012
Auth party contact address
-
Data no
298610
Title
Updated description of manufacture fill volume
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284192
Title
CVMP Summary of Product Characteristics
Study date
2023
Auth party contact address
-
Data no
298418
Title
Duration of immunity study 08-244-r
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298587
Title
La antigen manufacture method dated 07/24 draft
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284117
Title
Duramune Adult C3 APVMA label
Study date
2018
Auth party contact address
-
Data no
284166
Title
Updated manufacturing process and test method documentation and supporting inactivation kinetic and potency assay study reports
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284215
Title
Composition of Eurican DAPPi and DAP
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284235
Title
Duration of immunity studies
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296360
Title
Eudra GMP Certificate
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298518
Title
Annex-5-20: Description of Pharmacovigilance System
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284186
Title
EU registration dossier
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298424
Title
Onset of immunity study 10-0016-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284209
Title
Part 2E Control tests on the fnished product
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298544
Title
Validation study: 14-0365-r
Study date
2016
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298438
Title
Booster effect study14-0007-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284223
Title
Part 4 Efficacy documentation
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298630
Title
Control test technique - 11500
Study date
2006
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298636
Title
Clearance of adventitious virus during bovine albumin manufacture
Study date
1994
Auth party contact address
-
Data no
296366
Title
PV Report 2
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298481
Title
EU SPC for Eurican DAPPi suspension for injection
Study date
2021
Auth party contact address
-
Data no
298487
Title
CoA batch 193265D5A11
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298530
Title
Sterility test validation - 2022-1998
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298581
Title
Control test technique - 10036 version 2
Study date
2002
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284123
Title
Protech C2i formulation and specifications
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284172
Title
Part 2A Qualitative and quantitative particulars
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298645
Title
Part 4: Efficacy documentation
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298622
Title
Control test technique - 10001
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284204
Title
Part 2B Description of manufacturing method - actve ingredients
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298430
Title
Duration of immunity study 10-0125-r
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298528
Title
Dossier general table of contents
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298599
Title
EMA-CVMP Summary of Opinion - Eurican L4
Study date
2024
Auth party contact address
-
Data no
284227
Title
Booster efficacy study - 14.0007.r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298453
Title
Onset of immunity study 2020033-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298576
Title
L4 formulation and closures dated 06/24
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284158
Title
Responses to EU List of Questions
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298476
Title
Pharmacovigilance report - DAPPi-L3
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284181
Title
Rapporteur's Assessment Report
Study date
22 October 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298499
Title
CoA antigen batch 1LC5Y45
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284112
Title
Australian site - APVMA Licence
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298522
Title
Annex-5-9: GMP certificate for site 1
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284135
Title
Certificates of analysis - Active ingredients and finished product
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298545
Title
European batch release protocol
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298568
Title
Epizootic haemorrhagic disease (infection with epizootic haemorrhagic disease virus)
Study date
2021
Auth party contact address
-
Data no
284104
Title
Overseas sites - GMP certificates and Manufacturer's Authorisation
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298559
Title
Certificate of analysis - vaccine strain
Study date
2015
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298505
Title
Starting material specification-dmso
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284198
Title
Certificates of Analysis - L. grippotyphosa
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298605
Title
Batch production history
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284098
Title
Post-authorisation commitment
Study date
6 December 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298459
Title
2022-2000: Sterility test validation
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284167
Title
In process and finished product test methods
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284238
Title
Reproductive safety field study - 12.0258.r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298562
Title
Bovine Ephemeral Fever Virus Uses a Clathrin-Mediated and Dynamin 2-Dependent Endocytosis Pathway That Requires Rab5 and Rab7 as Well as Microtubules
Study date
2012
Auth party contact address
-
Data no
284144
Title
Updated method 200851
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298419
Title
Duration of immunity study 08-0246-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284118
Title
Nobivac Lepto 2 APVMA label
Study date
2023
Auth party contact address
-
Data no
298513
Title
Part 1: Table of contents
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298611
Title
Starting material of biological origin - specifications and CoAs
Study date
2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298539
Title
Identity test results Lc challenge strain
Study date
2008
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298588
Title
Acceptance letter Variation Eurican L4 May 2024
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284187
Title
Appendix 1 - Dossier structure
Study date
27 February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284210
Title
Part 2F Batch to batch consistency - active ingredients and finished product
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298519
Title
Annex-5-19: GMP compliance declaration
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298496
Title
CoA antigen batch 19LAUS6D04
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284161
Title
Batch production history and updated test method 10036
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298639
Title
EP monograph 0447
Study date
2013
Auth party contact address
-
Data no
296361
Title
Formulation details
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298439
Title
Compatibility study 14-0433-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298625
Title
Control test technique - 10075
Study date
2001
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298482
Title
Part 2: Table of Contents
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284175
Title
Environmental Risk Assessment - Part 3 Safety Documentation
Study date
2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284218
Title
Field safety study - 10.0488.r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284224
Title
Description of analytical methods - eu21d974
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284124
Title
Protech BB APVMA label
Study date
2014
Auth party contact address
-
Data no
298433
Title
Duration of immunity study 11-0145-r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298582
Title
Certificate of analysis for batch F89463
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298631
Title
Control test technique - 15312
Study date
2002
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284155
Title
Potency test method - 19312
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298479
Title
EU SPC for Eurican DAP suspension for injection
Study date
2021
Auth party contact address
-
Data no
298456
Title
Onset of immunity study 2020345-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284201
Title
Response to List of Questions
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298525
Title
Annex-5-4: EU letter of authorisation
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284178
Title
Protech C4 APVMA label
Study date
2018
Auth party contact address
-
Data no
298502
Title
Part 2D: In process control tests summary
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298642
Title
Risk assessment for bovine viruses in BSA
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298648
Title
Field safety and efficacy study: 2019426-r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284230
Title
Response to EMA list of questions 1
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298548
Title
EU SPC draft with tracked changes
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284207
Title
Part 2C2 Production and control of starting materials - active ingredient seeds
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298596
Title
APVMA-registered label for Protech BB
Study date
2025
Auth party contact address
-
Data no
284184
Title
EU Variation Dossier 1
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298619
Title
Control test technique - 001291
Study date
1999
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298556
Title
VMD List of Outstanding Issues
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284101
Title
Safety Update Report - Eurican L3
Study date
22 March 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284138
Title
Responses to VMS List of Questions
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298462
Title
Relevance of the leptospira challenge strains used to demonstrate efficacy (eu21d975)
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298602
Title
APVMA-approved label Duramune C3
Study date
2025
Auth party contact address
-
Data no
298416
Title
Stability study report - 19.0323-r
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284241
Title
Part 2F Batch consistency - finished product CoAs
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284195
Title
Rapporteurs assessment of responses to LoOI
Study date
27 January 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298608
Title
Validation of sterilisation by gamma irradiation
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284147
Title
Technical Document - Justification for variation
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298585
Title
List of starting materials for L4 product dated 07/24 draft
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298442
Title
Onset of immunity study 15-0382-r
Study date
2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298516
Title
EU product vial label
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284141
Title
Certificates of Analysis and seroneutralisation assessment reports
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298465
Title
EP Monograph-0451: Rabies vaccine (inactivated) for veterinary use
Study date
2021
Auth party contact address
-
Data no
284164
Title
Updated part 2B2 of dossier and certificate of conformity
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298565
Title
Tick-Borne Encephalitis Virus Infects Rat Astrocytes but Does Not Affect Their Viability
Study date
2014
Auth party contact address
-
Data no
298493
Title
CoA antigen batch P2LIH6J32
Study date
2012
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298542
Title
Identity test results La challenge strain
Study date
2015
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298422
Title
Duration of immunity study 09-0471-r
Study date
2011
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298473
Title
Field safety and efficacy study: 10-0491-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298485
Title
Part 2F: Batch consistency summary
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298579
Title
Countries in which the L3 products/combinations are registered
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298628
Title
Control test technique - 11350
Study date
1999
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284115
Title
Protech C3 APVMA label
Study date
2018
Auth party contact address
-
Data no
284127
Title
Detailed and Critical Summary (DACS) - Quality / CMC
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
298536
Title
Certificates of analysis - BSA
Study date
2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284121
Title
Versican Plus L4 suspension for injection SPC
Study date
2025
Auth party contact address
-
Data no
298436
Title
Compatibility study 12-0156-r
Study date
2014
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284221
Title
Field safety study - 10.0489.r
Study date
2013
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147680
Product/Active constituent Name
Application Product Name
Quantum Amitrole 47T Herbicide
Application Date
Application Number
147680
Application Product Name
Quantum Amitrole 47T Herbicide
Application details
Product name:
Quantum Amitrole 47T Herbicide
Product number:
95955
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 250 Amitrole and 220 Ammonium thiocyanate product, as a Soluble Concentrate (SL) formulation for the control of weeds in orchards, vineyards, irrigation ditches and drains, eucalyptus and pine plantations, roadsides, pre-plant wheat and barley, and for general industrial situations.
Reference details:
69890 - SABAKEM AMITROLE 47T HERBICIDE
Active constituents:
Active constituent name
68136 - AMITROLE
Active constituent name
47849 - AMITROLE
Description of data provided:
Data no
284570
Title
Executive Summary
Study date
February 2025
Auth party contact address
Suite 2, Level 7, 330 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
147918
Product/Active constituent Name
Application Product Name
APPARENT TRIFLURALIN 480 HERBICIDE
Application Date
Application Number
147918
Application Product Name
APPARENT TRIFLURALIN 480 HERBICIDE
Application details
Product name:
APPARENT TRIFLURALIN 480 HERBICIDE
Product number:
65080
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add a formulator and a formulation to the product's registration details.
Reference details:
65080 - APPARENT TRIFLURALIN 480 HERBICIDE
67329 - SABAKEM TRIFLURALIN 480EC SELECTIVE HERBICIDE
Active constituents:
Active constituent name
57874 - TRIFLURALIN
Active constituent name
44388 - TRIFLURALIN
Active constituent name
57910 - TRIFLURALIN
Active constituent name
56544 - TRIFLURALIN
Active constituent name
59597 - TRIFLURALIN
Active constituent name
56169 - TRIFLURALIN
Active constituent name
56267 - TRIFLURALIN
Active constituent name
63099 - TRIFLURALIN
Active constituent name
55865 - TRIFLURALIN
Description of data provided:
Data no
285331
Title
65080 AA letter
Study date
27 March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
147507
Product/Active constituent Name
Application Product Name
A.V.S.L. TIGER SNAKE ANTIVENOM
Application Date
Application Number
147507
Application Product Name
A.V.S.L. TIGER SNAKE ANTIVENOM
Application details
Product name:
A.V.S.L. TIGER SNAKE ANTIVENOM
Product number:
41849
Applicant Name:
AUSVETLAB PTY LTD
Application purpose and description of use:
Variation to the name and relevant particulars of product AVSL Tiger Snake Antivenom (41849) to make it a polyvalent veterinary snake antivenom which will treat bites from multiple species of snake. It will be called AVSL Tiger Brown Black Snake Antivenom.
Description of data provided:
Data no
283615
Title
Clinical trial responses
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283618
Title
Packaging specifications
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283612
Title
Stability of AVSL Tiger Brown Black Snake Antivenom (>16,000 units/ vial).
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283621
Title
SnakeMap: four years of experience with a national small animal snake envenomation registry.
Study date
9 September 2020
Auth party contact address
-
Data no
283613
Title
Flow diagram of manufacturing process
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283624
Title
Long-term physicochemical and immunological stability of a liquid formulated intact ovine immunoglobulin-based antivenom
Study date
11 January 2013
Auth party contact address
-
Data no
283610
Title
Batch analysis data
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283616
Title
Summary clinical trial data
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283611
Title
Verification of phenol content
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283622
Title
Snake bites recorded by veterinary practices in Australia.
Study date
1998
Auth party contact address
-
Data no
283619
Title
Chemicals and materials
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283625
Title
Venom yields from Australian and some other species of snake
Study date
26 August 2006
Auth party contact address
-
Data no
283620
Title
COMBINED DATA ANTIVENOM REPORT
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283614
Title
Chemistry data package
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Data no
283623
Title
Snake envenomation in dogs in New South Wales.
Study date
5 May 2005
Auth party contact address
-
Data no
283617
Title
Efficacy summary
Study date
2025
Auth party contact address
105 Norman Jones Lane ALSTONVILLE Australia
Date
Application Date
Application No
Application Number
148023
Product/Active constituent Name
Application Product Name
MELOXICASH 1.5 MG/ML ORAL SUSPENSION FOR DOGS
Application Date
Application Number
148023
Application Product Name
MELOXICASH 1.5 MG/ML ORAL SUSPENSION FOR DOGS
Application details
Product name:
MELOXICASH 1.5 MG/ML ORAL SUSPENSION FOR DOGS
Product number:
96046
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Registration of a 1.5 mg/mL meloxicam oral suspension product for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders such as discospondylosis, arthropathy and soft tissue injuries in dogs.
Reference details:
49655 - METACAM ANTI-INFLAMMATORY ORAL SUSPENSION FOR DOGS
Description of data provided:
Data no
285152
Title
Part 8 dossier
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285135
Title
GMP 1
Study date
2022
Auth party contact address
-
Data no
285141
Title
Excipients monographs
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285155
Title
Study report 2
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285149
Title
Stability 2
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
301308
Title
GMP
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285150
Title
Stability 3
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285153
Title
EU 2a
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285147
Title
EU 2a
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285136
Title
GMP 2
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285156
Title
Excipients information
Study date
2017
Auth party contact address
-
Data no
285148
Title
Stability 1
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
295805
Title
EU 2b
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
301309
Title
Product characteristics and report
Study date
2024
Auth party contact address
-
Data no
285145
Title
EU 2c3
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285151
Title
Stability 4
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285142
Title
Excipient information
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
301307
Title
Explanation
Study date
2026
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285137
Title
Part 2 dossier
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285143
Title
Excipient certificate of analysis
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285157
Title
Excipient information
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285140
Title
EU 2c2
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285146
Title
EU 2e
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
285154
Title
Study report 1
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
147633
Product/Active constituent Name
Application Product Name
Ant and Roach Granules
Application Date
Application Number
147633
Application Product Name
Ant and Roach Granules
Application details
Product name:
Ant and Roach Granules
Product number:
91312
Applicant Name:
Lifeguard Sciences (Pty) Ltd
Application purpose and description of use:
Variation to the label to include new pest/s for an approved crop/situation)
Active constituents:
Active constituent name
58418 - FIPRONIL
Description of data provided:
Data no
284448
Title
A study to test the efficacy of Optima Granular Bait against fire ants (Solenopsis sp.) in a laboratory trial.
Study date
04 November 2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
301477
Title
RESPONSE TO SECTION 159(1)(a) NOTICE FOR ANT AND ROACH GRANULES (APPLICATION NUMBER 147633)
Study date
16 February 2026
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
301480
Title
Collins & Callcott: Fipronil Bait for Control of Fire Ants
Study date
September 1998
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
301478
Title
A study to test the efficacy of Optima Granular Bait against fire ants (Solenopsis sp.) in a laboratory trial.
Study date
04 November 2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
289213
Title
PART 8 EFFICACY SUMMARY ? ANT AND ROACH GRANULES (91312/147633)
Study date
14 July 2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
301479
Title
A study to determine the efficacy of an Optima G granular bait product against ants in a field trial.
Study date
09 December 2016
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Date
Application Date
Application No
Application Number
147281
Product/Active constituent Name
Application Product Name
Submarino Azoxystrobin 250 SC Fungicide
Application Date
Application Number
147281
Application Product Name
Submarino Azoxystrobin 250 SC Fungicide
Application details
Product name:
Submarino Azoxystrobin 250 SC Fungicide
Product number:
95816
Applicant Name:
SUBMARINO PTY LTD
Application purpose and description of use:
Registration of a 250 g/L Azoxystrobin suspension concentrate product for for the control of various diseases of Grapes, Potatoes, Tomatoes, Cucurbits, Avocados, Mangoes, Passionfruit and Poppies as per the Directions for Use.
Reference details:
68714 - EZYCROP AZOXYSTROBIN 250 SC FUNGICIDE
Active constituents:
Active constituent name
67359 - AZOXYSTROBIN
Date
Application Date
Application No
Application Number
147765
Product/Active constituent Name
Application Product Name
Weed Force Skittle Herbicide
Application Date
Application Number
147765
Application Product Name
Weed Force Skittle Herbicide
Application details
Product name:
Weed Force Skittle Herbicide
Product number:
95973
Applicant Name:
WEED FORCE PTY LTD
Application purpose and description of use:
Registration of a 710 g/kg water dispersible granule formulation of 670 g/kg clopyralid and 40 g/kg sulfometuron methyl for control of a range of weeds in commercial and industrial areas, around agricultural areas and rights of way as specified in the Directions for Use
Reference details:
83925 - Weed Force Xtract 750 SG Broadleaf and Thistle Herbicide
80733 - WEED FORCE GROUND KEEPER HERBICIDE
Active constituents:
Active constituent name
53379 - CLOPYRALID
Active constituent name
47043 - SULFOMETURON-METHYL
Description of data provided:
Data no
285762
Title
Compare bioequivalence of a prototype WDG formulation (40 g/kg sulfometuron- methyl + 670 g/ha clopyralid) to equivalent mixes of WeedForce Ground Keeper + WeedForce Xtract on annual ryegrass (Lolium rigidum), brome grass (Bromus spp.), fleabane (Conyza bonariensis), spear (Cirsium vulgare) thistle
Study date
June 2023
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285129
Title
Part 8 - Efficacy
Study date
March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285765
Title
Compare bioequivalence of a prototype WDG formulation (40 g/kg sulfometuron- methyl + 670 g/ha clopyralid) to equivalent mixes of WeedForce Ground Keeper + WeedForce Xtract on annual ryegrass (Lolium rigidum), brome grass (Bromus spp.), fleabane (Conyza bonariensis), spear (Cirsium vulgare) thistle
Study date
May 2024
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285127
Title
Certificate of Analysis
Study date
2 May 2024
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285124
Title
Part 2 Chemistry and Manufacture
Study date
March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285130
Title
Evaluate bioequivalence of residual herbicides on annual ryegrass (Lolium rigidum), brome grass (Bromus spp.), fleabane (C. bonariensis), spear (C. vulgare) & scotch thistles (O. acanthium)
Study date
March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285125
Title
Method Validation for the determination of clopyralid and sulfometuron-methyl in Weed Force Herbicide
Study date
15 October 2024
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285131
Title
Draft label
Study date
March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285128
Title
C of A for actives
Study date
March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285763
Title
Compare bioequivalence of a prototype WDG formulation (40 g/kg sulfometuron- methyl + 670 g/ha clopyralid) to equivalent mixes of WeedForce Ground Keeper + WeedForce Xtract on annual ryegrass (Lolium rigidum), brome grass (Bromus spp.), fleabane (Conyza bonariensis), scotch (Onoporodum acanthium) thistle
Study date
August 2023
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285123
Title
Weed Force Skittle Herbicide - Executive Summary
Study date
3 March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285764
Title
Compare bioequivalence of a prototype WDG formulation (40 g/kg sulfometuron- methyl + 670 g/ha clopyralid) to equivalent mixes of WeedForce Ground Keeper + WeedForce Xtract on brome grass (Bromus spp.), fleabane (Conyza bonariensis), scotch (Onoporodum acanthium) thistle
Study date
August 2023
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285126
Title
SDS for inerts
Study date
March 2025
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Data no
285761
Title
Evaluate bioequivalence of residual herbicides on annual ryegrass (Lolium rigidum), brome grass (Bromus spp.), fleabane (Conyza bonariensis),
Study date
27 November 2024
Auth party contact address
1/18 Grandlee Drive WENDOUREE Australia
Date
Application Date
Application No
Application Number
147894
Product/Active constituent Name
Application Product Name
AC Dazzle 500 WG Herbicide
Application Date
Application Number
147894
Application Product Name
AC Dazzle 500 WG Herbicide
Application details
Product name:
AC Dazzle 500 WG Herbicide
Product number:
96008
Applicant Name:
AXICHEM PTY LTD
Application purpose and description of use:
The aim of this application is to apply for registration of a 500 g/kg water dispersible granule formulation of flumioxazin for the rapid knockdown and control of various grass and broadleaved weeds when mixed with certain glyphosate herbicides as per the Directions for Use table.
Reference details:
69830 - Nufarm Terrain 500 Herbicide
Active constituents:
Active constituent name
83607 - flumioxazin
Description of data provided:
Data no
285275
Title
Comparison of the pre-emergent efficacy of flumioxazin products, Terrain 500 WG Herbicide and Axichem Flumioxazin 500 WG Species: Sowthistle
Study date
September 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285272
Title
Crop safety comparison of Terrain 500 WG and Axichem Flumioxazin 500WG on wheat
Study date
September 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285264
Title
Part 2 Chemistry and Manufacture
Study date
March 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285267
Title
Certificate of Analysis
Study date
29 January 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285273
Title
Comparison of the knockdown efficacy of flumioxazin products, Terrain 500 WG Herbicide and Axichem Flumioxazin 500 WG, when applied with and without Glyphosate CT Species: Sowthistle
Study date
September 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285270
Title
Part 8 Efficacy and Crop Safety
Study date
March 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285276
Title
Comparison of the pre-emergent efficacy of two flumioxazin products, Terrain 500 WG Herbicide and Axichem Flumioxazin 500 WG Species: Volunteer canola
Study date
September 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285271
Title
Crop safety comparison of Terrain 500 WG and Axichem Flumioxazin 500WG on chickpeas
Study date
September 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285265
Title
SDS for Inerts
Study date
March 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285268
Title
Certificate of Analysis
Study date
9 July 2022
Auth party contact address
9 Palings Court NERANG Australia
Data no
285274
Title
Comparison of the knockdown efficacy of flumioxazin products, Terrain 500 WG Herbicide and Axichem Flumioxazin 500 WG, when applied with and without Glyphosate CT Species: Volunteer Canola
Study date
September 2021
Auth party contact address
9 Palings Court NERANG Australia
Data no
285269
Title
AC Dazzle 500 WG Herbicide Executive Summary
Study date
March 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285266
Title
Analytical Methods and Validation
Study date
21 January 2021
Auth party contact address
9 Palings Court NERANG Australia
Date
Application Date
Application No
Application Number
148095
Product/Active constituent Name
Application Product Name
TULATHROMYCIN
Application Date
Application Number
148095
Application Product Name
TULATHROMYCIN
Application details
Product name:
TULATHROMYCIN
Active name:
TULATHROMYCIN
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of active for use in veterinary chemical products.
Description of data provided:
Data no
298749
Title
Certificate of Analysis
Study date
12 Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298746
Title
Description of Manufacturing Process and Process Controls
Study date
Dec 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298752
Title
Elucidation of Structure
Study date
Dec 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298747
Title
Certificate of Analysis
Study date
12 Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298750
Title
Response letter
Study date
5 Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
285497
Title
CALAR_Variation Package_Tula_FIS
Study date
7 April 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298745
Title
s159 response
Study date
3/11/25
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298751
Title
Manufacturing Description-Active Substance
Study date
Dec 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
298748
Title
Certificate of Analysis
Study date
12 Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
147911
Product/Active constituent Name
Application Product Name
Fluxapyroxad
Application Date
Application Number
147911
Application Product Name
Fluxapyroxad
Application details
Product name:
Fluxapyroxad
Active name:
Fluxapyroxad
Applicant Name:
KINGTAI CHEMICALS CO., LIMITED
Application purpose and description of use:
Approval of Fluxapyroxad for use in agricultural chemical products.
Description of data provided:
Data no
285298
Title
Qualitative and Quantitative Profile of the Active Ingredient Fluxapyroxad and its Impurities of SCM PL FT 35-23
Study date
22 October 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
285296
Title
The Manufacturing Process of Fluxapyroxad Technical
Study date
19 August 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
285299
Title
Part 2 - Chemistry
Study date
11 March 2025
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
285297
Title
Declaration of Composition-Kingtai Fluxapyroxad Technical
Study date
11 March 2025
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Date
Application Date
Application No
Application Number
147588
Product/Active constituent Name
Application Product Name
Chlorhexidine Gluconate
Application Date
Application Number
147588
Application Product Name
Chlorhexidine Gluconate
Application details
Product name:
Chlorhexidine Gluconate
Active name:
Chlorhexidine Gluconate
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
New source of pharmacopoeia active constituent
Date
Application Date
Application No
Application Number
147591
Product/Active constituent Name
Application Product Name
Miconazole Nitrate
Application Date
Application Number
147591
Application Product Name
Miconazole Nitrate
Application details
Product name:
Miconazole Nitrate
Active name:
Miconazole Nitrate
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
New source of pharmacopoeia active constituent