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
148018
Product/Active constituent Name
Application Product Name
APPARENT AXEMAN 600 HERBICIDE
Application Date
Application Number
148018
Application Product Name
APPARENT AXEMAN 600 HERBICIDE
Application details
Product name:
APPARENT AXEMAN 600 HERBICIDE
Product number:
67727
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
To respond to an APVMA invitation to address product labelling in regard to the solvent statement on the product's label.
Active constituents:
Active constituent name
53667 - TRICLOPYR BUTOXYETHYL ESTER
Active constituent name
53104 - TRICLOPYR BUTOXYETHYL ESTER
Description of data provided:
Data no
285523
Title
67727 AA letter
Study date
30 March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
285524
Title
67727 invitation to submit item 13 application
Study date
20 March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
285525
Title
67727 Apparent Axeman 600 Herbicide application statement
Study date
2 April 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
148059
Product/Active constituent Name
Application Product Name
Aminopyralid
Application Date
Application Number
148059
Application Product Name
Aminopyralid
Application details
Product name:
Aminopyralid
Active name:
Aminopyralid
Applicant Name:
HUNAN BIDE BIOCHEMICAL TECHNOLOGY CO LTD
Application purpose and description of use:
Approval of Aminopyralid for use in agricultural chemical products.
Description of data provided:
Data no
285629
Title
Determination of Active Content and Impurity Profile of Aminopyralid
Study date
7 August 2024
Data no
285627
Title
Aminopyralid Technical Synthesis Process
Study date
4 September 2024
Data no
285628
Title
Declaration of Composition
Study date
20 January 2024
Data no
285630
Title
Aminopyralid Technical
Study date
26 March 2025
Data no
285626
Title
Executive Summary
Study date
March 2025
Date
Application Date
Application No
Application Number
148020
Product/Active constituent Name
Application Product Name
Imazalil
Application Date
Application Number
148020
Application Product Name
Imazalil
Application details
Product name:
Imazalil
Active name:
Imazalil
Applicant Name:
JANSSEN PHARMACEUTICA N.V.
Application purpose and description of use:
Approval of new source of Imazalil for use in agricultural chemical products.
Description of data provided:
Data no
285552
Title
Determination of Imazalil (R023979), Impurities and Toluene in five batches of Imazalil Technical (R023979)
Study date
05 June 2023
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285554
Title
Product Specification Report for Imazalil technical
Study date
07 May 2024
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285555
Title
Validation of an analytical method for the content determination of imazalil (R023979) in imazalil technical (R023979)
Study date
09 November 2022
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285556
Title
Validation of an analytical method for the content determination of the solvent toluene in imazalil technical (R023979)
Study date
09 November 2022
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285557
Title
Determination of imazalil and impurities in five batches of R023979
Study date
15 March 2011
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285553
Title
Manufacturing directions report
Study date
November 2023
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285550
Title
Chemistry and manufacture dossier
Study date
25 March 2025
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285551
Title
Declaration of composition
Study date
17 March 2025
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Date
Application Date
Application No
Application Number
148021
Product/Active constituent Name
Application Product Name
Imazalil Sulfate
Application Date
Application Number
148021
Application Product Name
Imazalil Sulfate
Application details
Product name:
Imazalil Sulfate
Active name:
Imazalil Sulfate
Applicant Name:
JANSSEN PHARMACEUTICA N.V.
Application purpose and description of use:
Approval of new source of Imazalil sulfate for use in agricultural chemical products.
Description of data provided:
Data no
285590
Title
Determination of Imazalil Sulphate (R027180), Impurities and Toluene in five batches of Imazalil Sulphate Technical (R027180)
Study date
05 June 2023
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285592
Title
Product Specification Report for Imazalil Sulphate
Study date
May 2024
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285593
Title
Validation of an analytical method for the content determination of imazalil sulphate (R027180) in imazalil sulphate technical (R027180)
Study date
09 November 2025
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285594
Title
Validation of an analytical method for the content determination of the solvent toluene in imazalil sulphate technical (R027180)
Study date
09 November 2025
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285591
Title
Manufacturing directions report
Study date
November 2023
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285588
Title
Chemistry and manufacture dossier
Study date
25 March 2025
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Data no
285589
Title
Declaration of composition
Study date
17 March 2025
Auth party contact address
TURNHOUTSEWEG 30 B-2340 BEERSE Belgium
Date
Application Date
Application No
Application Number
147970
Product/Active constituent Name
Application Product Name
WHITE MARKING FOAM
Application Date
Application Number
147970
Application Product Name
WHITE MARKING FOAM
Application details
Product name:
WHITE MARKING FOAM
Product number:
64146
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
Variation of product registration to amend the label text.
Active constituents:
Active constituent name
60480 - LAURYL ALCOHOL
Active constituent name
60479 - SODIUM LAURYL ETHER SULFATE
Description of data provided:
Data no
285522
Title
Item 13 Invitation
Study date
2025
Auth party contact address
43 Gap Road Sunbury Australia
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
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
148050
Product/Active constituent Name
Application Product Name
YATES HOME PEST COCKROACH SUPER BAITS
Application Date
Application Number
148050
Application Product Name
YATES HOME PEST COCKROACH SUPER BAITS
Application details
Product name:
YATES HOME PEST COCKROACH SUPER BAITS
Product number:
92781
Applicant Name:
SETANTA INVESTMENTS PTY LTD
Application purpose and description of use:
Variation of product registration to allow for slight changes in some non active ingredient specifications.
Active constituents:
Active constituent name
69811 - INDOXACARB
Description of data provided:
Data no
285596
Title
Permit 9429341
Study date
27/9/24
Auth party contact address
3 St Clair Street BOWRAL Australia
Date
Application Date
Application No
Application Number
148051
Product/Active constituent Name
Application Product Name
TITAN S-METOLACHLOR 960 HERBICIDE
Application Date
Application Number
148051
Application Product Name
TITAN S-METOLACHLOR 960 HERBICIDE
Application details
Product name:
TITAN S-METOLACHLOR 960 HERBICIDE
Product number:
69410
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add claims to the label and add 3 formulation sites to registration details
Active constituents:
Active constituent name
67054 - S-METOLACHLOR
Description of data provided:
Data no
285597
Title
Application to add claims to Titan S-metolachlor 960
Study date
February 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
148124
Product/Active constituent Name
Application Product Name
MELOXICAM
Application Date
Application Number
148124
Application Product Name
MELOXICAM
Application details
Product name:
MELOXICAM
Active name:
MELOXICAM
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Approval of meloxicam for use in veterinary chemical products.
Description of data provided:
Data no
285222
Title
Product specifications
Study date
2025
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Date
Application Date
Application No
Application Number
148054
Product/Active constituent Name
Application Product Name
Titan Immense Herbicide
Application Date
Application Number
148054
Application Product Name
Titan Immense Herbicide
Application details
Product name:
Titan Immense Herbicide
Product number:
88704
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add control of weeds in sorghum and sunflower to claims and directions for use. We have added claims for INZEN® herbicide tolerant grain sorghum and igrowth® herbicide tolerant grain sorghum to the label and Imidazolinone tolerant sunflower varieties only to the label. The addition of these claims to the label does not conflict with protected data, and efficacy data provided with this application provides evidence of efficacy and crop safety in both crops
Active constituents:
Active constituent name
69653 - IMAZAMOX
Active constituent name
80109 - Imazapyr
Active constituent name
91027 - Imazamox
Active constituent name
69003 - IMAZAPYR
Description of data provided:
Data no
285598
Title
BIOEQUIVALENCE OF TITAN IMMENSE WITH INTERVIX?? FOR WEED CONTROL AND CROP SAFETY IN IG SORGHUM CV. VIPER
Study date
March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
285599
Title
BIOEQUIVALENCE OF TITAN IMMENSE WITH INTERVIX FOR WEED CONTROL AND CROP SAFETY IN IG SORGHUM CV. VIPER
Study date
March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
285600
Title
BIOEQUIVALENCE OF TITAN IMMENSE WITH INTERVIX FOR WEED CONTROL AND CROP SAFETY IN CLEARFIELD SUNFLOWERS CV. AUSSIECLEAR
Study date
March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
289324
Title
IMMENSE Response to s159 FINAL 17072025
Study date
July 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
285601
Title
Executive Summary: Variation to label of Titan Immense Herbicide (88704)
Study date
April 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
289321
Title
ATT II Imidazolinone-tolerant crops_ history, current status and future - PubMed
Study date
March 2005
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
289322
Title
IMI-tolerant crops - use sparingly and to best effect - WeedSmart
Study date
August 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
289323
Title
Control of conventional and Clearfield volunteer oilseed rape in spring barley
Study date
April 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
148003
Product/Active constituent Name
Application Product Name
fipronil
Application Date
Application Number
148003
Application Product Name
fipronil
Application details
Product name:
fipronil
Active name:
fipronil
Applicant Name:
ENSYSTEX AUSTRALASIA PTY LTD
Application purpose and description of use:
Approval of fipronil for use in agricultural chemical products.
Description of data provided:
Data no
285499
Title
Qualitative and quantitative profile of fipronil technical (Five batch analysis)
Study date
25/11/2021
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
285500
Title
Manufacturing process of fipronil technical
Study date
10/02/2025
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
285501
Title
Certificate of Analysis
Study date
31/05/2024
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
285502
Title
Part 2 Summary
Study date
2025
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
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
285465
Title
Updated method 200851
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
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
285469
Title
Part 2B flow chart
Study date
2024
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
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
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
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
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
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
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
285444
Title
Validation study 19.0026.R
Study date
2020
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
285447
Title
Validation Study 19.0027r
Study date
2019
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
285450
Title
Validation Study 18.0549r
Study date
2019
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
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
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
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
285443
Title
Validation Study 07.0541.R
Study date
2021
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
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
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
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
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
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
285466
Title
Health monitoring report
Study date
2022
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
285449
Title
Validation study 18.0550r
Study date
2019
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
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
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
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
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
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
285452
Title
Validation study 19.0119r
Study date
2020
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
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
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
285471
Title
Updated 2B2
Study date
2022
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
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
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
284155
Title
Potency test method - 19312
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
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
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
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
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
284184
Title
EU Variation Dossier 1
Study date
2024
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
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
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
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
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
284170
Title
Inactivation kinetic studies
Study date
2021
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
284133
Title
Master seeds - specfications and CoAs
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
284144
Title
Updated method 200851
Study date
2022
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
284147
Title
Technical Document - Justification for variation
Study date
2024
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
284150
Title
Technical document - Justification for variation
Study date
2024
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
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
284153
Title
Updated Part 2B Manufacturing method
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
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
284130
Title
Validation studies
Study date
2021
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
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
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
284142
Title
Test method 10036 validation study
Study date
2022
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
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
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
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
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
296360
Title
Eudra GMP Certificate
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296361
Title
Formulation details
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
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
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
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
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
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
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
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
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
284139
Title
Updated dossier Part 2A - Conclusion
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
284140
Title
Biological ingredient suppliers
Study date
2022
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
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
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
284128
Title
Container closure system
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
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
284112
Title
Australian site - APVMA Licence
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
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
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
296363
Title
Import permit
Study date
2025
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
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
284136
Title
Pat 2G Stability tests
Study date
2021
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
284198
Title
Certificates of Analysis - L. grippotyphosa
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
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
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
284231
Title
Certificates of analysis
Study date
2022
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
284224
Title
Description of analytical methods - eu21d974
Study date
2021
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
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
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
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
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
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
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
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
284235
Title
Duration of immunity studies
Study date
2021
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
296365
Title
Summary Update Report
Study date
2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296366
Title
PV Report 2
Study date
2025
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
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
284177
Title
Protech C2i APVMA label
Study date
2013
Auth party contact address
-
Data no
284178
Title
Protech C4 APVMA label
Study date
2018
Auth party contact address
-
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
284120
Title
Emerging leptospirosis in urban Sydney dogs: a case series (2017-2020).
Study date
2022
Auth party contact address
-
Data no
284121
Title
Versican Plus L4 suspension for injection SPC
Study date
2025
Auth party contact address
-
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
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
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
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
284111
Title
Expert Report
Study date
14 February 2025
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
284124
Title
Protech BB APVMA label
Study date
2014
Auth party contact address
-
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
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
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
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
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
284113
Title
European consensus statement on leptospirosis in dogs and cats.
Study date
2015
Auth party contact address
-
Data no
284114
Title
Updated ACVIM consensus statement on leptospirosis in dogs.
Study date
2023
Auth party contact address
-
Data no
284115
Title
Protech C3 APVMA label
Study date
2018
Auth party contact address
-
Data no
284116
Title
Duramune Adult C4 APVMA label
Study date
2018
Auth party contact address
-
Data no
284117
Title
Duramune Adult C3 APVMA label
Study date
2018
Auth party contact address
-
Data no
284118
Title
Nobivac Lepto 2 APVMA label
Study date
2023
Auth party contact address
-
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
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
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
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
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
284221
Title
Field safety study - 10.0489.r
Study date
2013
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
284237
Title
Safety study 19.0006.r
Study date
2019
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
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
284213
Title
Part 3 Safety documentation
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
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
284105
Title
Letter of Authorisation
Study date
5 December 2024
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
284119
Title
Control of canine leptospirosis in Europe: time for a change?
Study date
2010
Auth party contact address
-
Data no
284122
Title
Nobivac L4 suspension for injection
Study date
2025
Auth party contact address
-
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
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
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
284096
Title
Application Overview
Study date
27 February 2025
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
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
284186
Title
EU registration dossier
Study date
2021
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
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
284189
Title
CVMP positive opinion summary
Study date
17 February 2023
Auth party contact address
-
Data no
284190
Title
CVMP public assessment report
Study date
15 February 2023
Auth party contact address
-
Data no
284191
Title
European Commission Decision
Study date
31 March 2023
Auth party contact address
-
Data no
284192
Title
CVMP Summary of Product Characteristics
Study date
2023
Auth party contact address
-
Data no
284193
Title
VMD Summary of Product Characteristics
Study date
August 2023
Auth party contact address
-
Data no
284194
Title
VMD Public assessment report
Study date
August 2023
Auth party contact address
-
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
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
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
284180
Title
CVMP Opinion
Study date
14 November 2024
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
284182
Title
CVMP Opinion
Study date
7 November 2024
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
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
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
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
284098
Title
Post-authorisation commitment
Study date
6 December 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
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
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
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
284149
Title
Responses to List of Questions
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
284174
Title
User safety - Part 3 Safety Documentation
Study date
2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
147324
Product/Active constituent Name
Application Product Name
NP-1 ANTI-SAPSTAIN CHEMICAL
Application Date
Application Number
147324
Application Product Name
NP-1 ANTI-SAPSTAIN CHEMICAL
Application details
Product name:
NP-1 ANTI-SAPSTAIN CHEMICAL
Product number:
52291
Applicant Name:
KOP-COAT AUSTRALIA PTY. LTD.
Application purpose and description of use:
Variation of NP-1 product registration to include additional manufacturer, amend product pack size/material and update product label
Active constituents:
Active constituent name
44149 - 3-IODO-2-PROPYNYL-N-BUTYL CARBAMATE
Date
Application Date
Application No
Application Number
147929
Product/Active constituent Name
Application Product Name
ACP FLOOD 1000 SURFACTANT
Application Date
Application Number
147929
Application Product Name
ACP FLOOD 1000 SURFACTANT
Application details
Product name:
ACP FLOOD 1000 SURFACTANT
Product number:
67763
Applicant Name:
AUSTRALIS CROP PROTECTION PTY LTD
Application purpose and description of use:
Variation of label approval to update to current statutaoy criteria as per Item 13 Letter
Active constituents:
Active constituent name
59656 - ALCOHOL ETHOXYLATE
Active constituent name
59943 - NONYL PHENOL ETHOXYLATE
Description of data provided:
Data no
285563
Title
Item 13- 67763 APVMA Letter
Study date
13 March 2025
Auth party contact address
SHOP 4, 30 HEBER STREET MOREE Australia
Date
Application Date
Application No
Application Number
147919
Product/Active constituent Name
Application Product Name
TITAN Leftin 770 Spray Adjuvant
Application Date
Application Number
147919
Application Product Name
TITAN Leftin 770 Spray Adjuvant
Application details
Product name:
TITAN Leftin 770 Spray Adjuvant
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of a 334g/L non-ionic surfactant blend, 300g/L ammonium sulphate and 136g/L vegetable oil ester micro emulsion product as an adjuvant for knockdown herbicides.