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
148135
Product/Active constituent Name
Application Product Name
Spalding Jäger Gold Herbicide
Application Date
Application Number
148135
Application Product Name
Spalding Jäger Gold Herbicide
Application details
Product name:
Spalding Jäger Gold Herbicide
Product number:
96087
Applicant Name:
DGL GROUP LIMITED
Application purpose and description of use:
Registration of an 800 g/L prosulfocarb and 120 g/L s-metolachlor emulsifiable concentrate EC product for the Control
of Annual Ryegrass (Lolium rigidum) and other grasses and broadleaf weeds in various crops
Reference details:
61234 - BOXER GOLD HERBICIDE
Active constituents:
Active constituent name
80726 - Prosulfocarb
Active constituent name
69340 - S-METOLACHLOR
Description of data provided:
Data no
285710
Title
Scientific argument for acceptance of Spalding Jager Gold Herbicide
Study date
8 April 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285708
Title
Evaluation of Spalding J??ger Gold Herbicide for the control of Silver grass (Vulpia bromoides, Vulpia myuros) in cereals
Study date
3 January 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285705
Title
Certificate of Analysis
Study date
28 February 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285711
Title
Proposed RLP
Study date
9 April 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285706
Title
Method Validation for the determination of prosulfocarb and metolachlor in J??ger Herbicide
Study date
28 February 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285709
Title
Evaluation of Spalding J??ger Gold Herbicide for the control of Annual Ryegrass (Lolium rigidum) in lupins
Study date
16 January 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285703
Title
Chemistry and Manufacturing for Spalding J??ger Gold Herbicide
Study date
March 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285704
Title
Raw Material Specifications
Study date
24 March 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Data no
285707
Title
Part 8 Efficacy and Crop Safety
Study date
9 April 2025
Auth party contact address
120 Fulton Drive Derrimut Australia
Date
Application Date
Application No
Application Number
148209
Product/Active constituent Name
Application Product Name
GENFARM DIAFENTHIURON 500 SC INSECTICIDE
Application Date
Application Number
148209
Application Product Name
GENFARM DIAFENTHIURON 500 SC INSECTICIDE
Application details
Product name:
GENFARM DIAFENTHIURON 500 SC INSECTICIDE
Product number:
96116
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a 500 g/L diafenthiuron suspension concentrate insecticide for the control of two-spotted mite and cotton aphids in cotton, suppression of silverleaf whitefly in cotton, control of red-legged earth mite in canola and suppression of lucerne flea in canola.
Reference details:
91583 - RECEPTOR INSECTICIDE
Active constituents:
Active constituent name
65920 - DIAFENTHIURON
Description of data provided:
Data no
286077
Title
Manufacturing Process for Genfarm Diafenthiuron 500 SC Insecticide
Study date
02-Aug-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286074
Title
Certificate of Analysis
Study date
14-Jun-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286080
Title
Crop safety & efficacy of Diafenthiuron 500 SC Insecticide for control of RLEM in Canola, Temora NSW
Study date
29-Jul-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286083
Title
Part 8, Efficacy & Crop Safety of Genfarm Diafenthiuron 500 SC Insecticide
Study date
16-Apr-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286075
Title
Safety Data Sheets
Study date
23-Dec-2022
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286078
Title
Method Validation of Genfarm Diafenthiuron 500 SC Insecticide
Study date
01-May-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286081
Title
Crop safety & efficacy of Diafenthiuron 500 SC Insecticide for control of Lucerne flea in Canola, Goulburn NSW
Study date
29-Jul-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286073
Title
Product Stability of Genfarm Diafenthiuron 500 SC Insecticide
Study date
02-Aug-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286079
Title
Crop safety & efficacy evaluation of Diafenthiuron 500 SC Insecticide for control of Two-spotted spider mite in Cotton, Coleambally NSW
Study date
29-Jul-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286082
Title
Crop safety & efficacy of Diafenthiuron 500 SC Insecticide for control of RLEM in Canola, Northam WA
Study date
4-Dec-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
286076
Title
Part 2, Chemistry & Manufacture for Genfarm Diafenthiuron 500 SC Insecticide
Study date
16-Apr-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
148150
Product/Active constituent Name
Application Product Name
SAS PRO PROFESSIONAL GRANULE ANT KILLER
Application Date
Application Number
148150
Application Product Name
SAS PRO PROFESSIONAL GRANULE ANT KILLER
Application details
Product name:
SAS PRO PROFESSIONAL GRANULE ANT KILLER
Product number:
67629
Applicant Name:
SUNDEW SOLUTIONS PTY LTD
Application purpose and description of use:
Variation of label approval to add an improved method of product application for the control of red imported fire ants.
Active constituents:
Active constituent name
51985 - FIPRONIL
Active constituent name
59286 - FIPRONIL
Description of data provided:
Data no
285670
Title
SAS PRO Professional Granule Ant Killer Application Statement
Study date
8 April 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
293201
Title
Additional trial data referred to in the letter of support from the National Fire Ant Eradication Program dated 18 September 2014
Study date
8 September 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
302072
Title
The red imported fire ant, Solenopsis invicta, in early-successional coastal plain forests: tests of distribution and interaction strength
Study date
6 May 1998
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
293204
Title
Field trial response
Study date
9 September 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
302073
Title
Red imported fire ant in Australia: what if we lose the war?
Study date
1 October 2016
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
285671
Title
Field Evaluation of SAS PRO (0.25g/kg fipronil, APVMA Approval Number 67629) for Improved Direct Nest Application against Red Imported Fire Ants (Solenopsis invicta)
Study date
27 August 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
293202
Title
Nest density response
Study date
7 September 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
285672
Title
Letter of support from FAEP
Study date
September 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
302071
Title
Clarification of nest density references
Study date
24 November 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
293203
Title
Summary of responses to S159
Study date
8 September 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
285669
Title
67629 AA letter
Study date
10 April 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Date
Application Date
Application No
Application Number
148151
Product/Active constituent Name
Application Product Name
Amgrow Patrol Fire Ant Killer Granules
Application Date
Application Number
148151
Application Product Name
Amgrow Patrol Fire Ant Killer Granules
Application details
Product name:
Amgrow Patrol Fire Ant Killer Granules
Product number:
90728
Applicant Name:
SUNDEW SOLUTIONS PTY LTD
Application purpose and description of use:
Variation of label approval to add an improved method of product application for the control of red imported fire ants.
Active constituents:
Active constituent name
54624 - TERMIDOR RESIDUAL TERMITICIDE AND INSECTICIDE
Description of data provided:
Data no
285688
Title
90728 AA letter
Study date
10 April 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
285689
Title
SAS PRO Professional Granule Ant Killer Application Statement
Study date
8 April 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Date
Application Date
Application No
Application Number
148152
Product/Active constituent Name
Application Product Name
INSTAR GRANULAR INSECTICIDE
Application Date
Application Number
148152
Application Product Name
INSTAR GRANULAR INSECTICIDE
Application details
Product name:
INSTAR GRANULAR INSECTICIDE
Product number:
68975
Applicant Name:
SUNDEW SOLUTIONS PTY LTD
Application purpose and description of use:
Variation of label approval to add an improved method of product application for the control of red imported fire ants.
Active constituents:
Active constituent name
51985 - FIPRONIL
Active constituent name
59286 - FIPRONIL
Description of data provided:
Data no
285690
Title
68975 AA letter
Study date
10 April 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
285691
Title
SAS PRO Professional Granule Ant Killer Application Statement
Study date
8 April 2025
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Date
Application Date
Application No
Application Number
148153
Product/Active constituent Name
Application Product Name
Conquest Arrow Ultra Insecticide
Application Date
Application Number
148153
Application Product Name
Conquest Arrow Ultra Insecticide
Application details
Product name:
Conquest Arrow Ultra Insecticide
Product number:
96092
Applicant Name:
CONQUEST CROP PROTECTION PTY LTD
Application purpose and description of use:
Registration of a 300g/L bifenthrin for the management of pests in various situations as per directions for use.
Reference details:
88309 - 4FARMERS BIFENTHRIN 300 EC INSECTICIDE
Active constituents:
Active constituent name
65341 - BIFENTHRIN
Description of data provided:
Data no
285631
Title
(01) - Application Overview
Study date
April 2025
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Data no
285632
Title
(02) - Appendix 1 - Stability and Batch Analysis Data
Study date
Mar 2025
Auth party contact address
LEVEL 1, 3A COLLINGWOOD STREET OSBORNE PARK Australia
Date
Application Date
Application No
Application Number
148075
Product/Active constituent Name
Application Product Name
AC Pumpa Au Herbicide
Application Date
Application Number
148075
Application Product Name
AC Pumpa Au Herbicide
Application details
Product name:
AC Pumpa Au Herbicide
Product number:
96072
Applicant Name:
AXICHEM PTY LTD
Application purpose and description of use:
Registration of a 800 g/L prosulfocarb, 120 g/L S-metolachlor emulsifiable concentrate formulation the control of annual Ryegrass (Lolium rigidum) and other grass and broadleaf weeds in barley, chickpeas, faba Beans, field Peas, lentils, oats, potatoes, triticale and wheat.
Reference details:
61234 - BOXER GOLD HERBICIDE
Active constituents:
Active constituent name
80726 - Prosulfocarb
Active constituent name
80258 - S-Metolachlor
Description of data provided:
Data no
285653
Title
Part 8 Effiacy and Crop Safety
Study date
April 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285647
Title
Method Validation for the determination of prsulfocarb and metolachlor in Boxer Gold
Study date
28 February 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285656
Title
SCIENTIFIC ARGUMENT FOR ACCEPTANCE OF AC Pumpa Au Herbicide AS AN EQUIVALENT TO Boxer Gold Herbicide (APVMA Approval No. 61234)
Study date
April 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285650
Title
C of A for actives
Study date
April 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285651
Title
SCIENTIFIC ARGUMENT FOR ACCEPTANCE OF AC Pumpa Au Herbicide AS AN EQUIVALENT TO Boxer Gold Herbicide (APVMA Approval No. 61234)
Study date
April 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285654
Title
Evaluate of AC Pumpa Au Herbicide for the control of Silver grass (Vulpia bromoides, Vulpia myuros) in Oats
Study date
3 January 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285648
Title
Certificate of Analysis
Study date
28 February 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285649
Title
SDS for inerts
Study date
April 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285646
Title
Part 2 Chemsitry and Manufacture
Study date
April 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285655
Title
Evaluate of AC Pumpa Herbicide for the control of Annual Ryegrass (Lolium rigidum) in lupins
Study date
16 January 2025
Auth party contact address
9 Palings Court NERANG Australia
Data no
285652
Title
Executive Summary
Study date
7 April 2025
Auth party contact address
9 Palings Court NERANG Australia
Date
Application Date
Application No
Application Number
148086
Product/Active constituent Name
Application Product Name
Vetsense VETCOX COCCIDIOCIDE SOLUTION FOR POULTRY
Application Date
Application Number
148086
Application Product Name
Vetsense VETCOX COCCIDIOCIDE SOLUTION FOR POULTRY
Application details
Product name:
Vetsense VETCOX COCCIDIOCIDE SOLUTION FOR POULTRY
Product number:
96073
Applicant Name:
VETSENSE PTY LTD
Application purpose and description of use:
Registration of a 25 g/L toltrazuril solution for the treatment and control of coccidiosis in chickens caused by Eimeria species.
Reference details:
45626 - BAYCOX COCCIDIOCIDE SOLUTION
Active constituents:
Active constituent name
94438 - Toltrazuril
Description of data provided:
Data no
285132
Title
Excipients CoA
Study date
2025
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
285133
Title
API CoA
Study date
2025
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
285134
Title
PRODUCT SPECIFICATIONS - VETCOX COCCIDIOCIDE SOLUTION FOR POULTRY
Study date
Apr 2025
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Date
Application Date
Application No
Application Number
148032
Product/Active constituent Name
Application Product Name
Quantum Imazapic 240 SLHerbicide
Application Date
Application Number
148032
Application Product Name
Quantum Imazapic 240 SLHerbicide
Application details
Product name:
Quantum Imazapic 240 SLHerbicide
Product number:
96049
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 240g/L Imazapic soluble concentrate (SL) product for the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts and early post-emergence control of certain annual grass and broadleaf weed in peanuts and sugarcane as specified in the Directions for Use section of this label.
Reference details:
69276 - SABAKEM IMAZAPIC 240SL HERBICIDE
Active constituents:
Active constituent name
63160 - IMAZAPIC
Active constituent name
61266 - IMAZAPIC
Date
Application Date
Application No
Application Number
148129
Product/Active constituent Name
Application Product Name
LIBEN_Terbubest 875WG Herbicide
Application Date
Application Number
148129
Application Product Name
LIBEN_Terbubest 875WG Herbicide
Application details
Product name:
LIBEN_Terbubest 875WG Herbicide
Product number:
96082
Applicant Name:
Hebei Shanli Chemical Company Limited
Application purpose and description of use:
Registration of a 875 g/kg Terbuthylazine water dispersible granule (WG) formulation for the control of weeds in chickpeas, faba beans, fallows, field peas, lentils, lupins, sorghum and triazine tolerant canola.
Reference details:
80864 - Farmalinx Sputnik Herbicide
Active constituents:
Active constituent name
90138 - TERBUTHYLAZINE
Description of data provided:
Data no
285618
Title
Terbuthylazine Active Approved Certificate + COA
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Date
Application Date
Application No
Application Number
148034
Product/Active constituent Name
Application Product Name
Quantum Imidacloprid 350 SC Insecticide
Application Date
Application Number
148034
Application Product Name
Quantum Imidacloprid 350 SC Insecticide
Application details
Product name:
Quantum Imidacloprid 350 SC Insecticide
Product number:
96051
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 350 g/L Imidacloprid suspension concentrate (SC) product for the control of various soil pests in sugarcane and peanuts, certain pests in apples, citrus and various vegetable crops by soil treatment, and for the control of certain pests in bananas by pseudostem injection as specified in the DIRECTIONS FOR USE table
Reference details:
69122 - SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Description of data provided:
Data no
306661
Title
Advice Summary
Study date
2009
Auth party contact address
-
Data no
306662
Title
TAN Notice
Study date
2009
Auth party contact address
-
Data no
306663
Title
Public release document
Study date
1997
Auth party contact address
-
Data no
306660
Title
Scientific argument to address proposal to refuse
Study date
20 June 2026
Auth party contact address
Suite 2, Level 7, 330 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
148036
Product/Active constituent Name
Application Product Name
Quantum Haloxyfop 520 EC Herbicide
Application Date
Application Number
148036
Application Product Name
Quantum Haloxyfop 520 EC Herbicide
Application details
Product name:
Quantum Haloxyfop 520 EC Herbicide
Product number:
96053
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 520g/L Haloxyfop present as the haloxyfop-P-methyl ester Emulsifiable concentrate (EC) product for the post emergent control of a wide range of annual and perennial grass weeds in grain legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops as specified in the Direction for Use.
Reference details:
69155 - SABAKEM HALOXYFOP 520EC HERBICIDE
Date
Application Date
Application No
Application Number
148035
Product/Active constituent Name
Application Product Name
Quantum Metsulfuron 600 WG Herbicide
Application Date
Application Number
148035
Application Product Name
Quantum Metsulfuron 600 WG Herbicide
Application details
Product name:
Quantum Metsulfuron 600 WG Herbicide
Product number:
96052
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 600g/kg Metsulfuron-methyl water dispersible granule (WG) product for the control of brush and broadleaf weeds in native pastures, Agricultural Non-crop Areas, rights of way, commercial and industrial areas and for the control of certain broadleaf weeds in winter cereal crops and in mung beans for field crop desiccation as per
the Directions of Use Table.
Reference details:
69255 - SABAKEM METSULFURON 600WG HERBICIDE
Active constituents:
Active constituent name
93972 - Metsulfuron-methyl
Active constituent name
47045 - METSULFURON-METHYL
Date
Application Date
Application No
Application Number
148037
Product/Active constituent Name
Application Product Name
Quantum Tebuconazole 430 SC Fungicide
Application Date
Application Number
148037
Application Product Name
Quantum Tebuconazole 430 SC Fungicide
Application details
Product name:
Quantum Tebuconazole 430 SC Fungicide
Product number:
96054
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 430 g/L Tebuconazole suspension concentrate (SC) product for THE CONTROL OF LEAF SPOT AND LEAF SPECKLE ON BANANAS, DUBOISIA, FABA BEANS, BROAD BEANS; MYRTLE RUST ON ANISE MYRTLE, LEMON MYRTLE, OIL TEA TREE, NON-FOOD PRODUCING PLANTS AND VEGETATION; ORANGE RUST ON GARLIC; POWDERY MILDEW ON CARROTS, MUNG BEANS, SOYA BEANS; APICAL NECROSIS ON WALNUTS; RUST, LEAF SPOT AND NET BLOTCH OF PEANUTS; FOLIAR DISEASES ON CEREAL CROPS; AND OTHER DISEASES ON BEANS, PEAS, ONIONS, PAWPAW, PYRETHRUM, AND RYEGRASS AND FESCUE SEED CROPS AS SPECIFIED IN THE DIRECTIONS FOR USE TABLE.
Reference details:
67481 - SABAKEM TEBUCONAZOLE 430SC FUNGICIDE
Active constituents:
Active constituent name
66062 - TEBUCONAZOLE
Active constituent name
68135 - TEBUCONAZOLE
Active constituent name
67396 - TEBUCONAZOLE
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
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.
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
307700
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
307708
Title
Validation study 2021-1299r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307709
Title
Updated 2B2
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307704
Title
Bulk antigen certificates of analysis
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307698
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
307702
Title
Part 2F Batch consistency - active ingredient CoAs
Study date
2024
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.
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
307697
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
307703
Title
Bulk antigen certificates of analysis
Study date
2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307706
Title
Validation study 06.0213r
Study date
2010
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307701
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
307707
Title
Validation study 2021-1299r
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307699
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
307705
Title
Validation Study 07.0541.R
Study date
2021
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.
Description of data provided:
Data no
306775
Title
Eurican L4 Compatibility with Eurican DAPPi by in-vitro testing
Study date
February 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
304279
Title
Certificate of analysis-APVMA ref no 284133
Study date
2025
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
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
305877
Title
Section 159(1)(a) Notice of requirement of information, report or sample
Study date
29/05/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
304277
Title
Response to 8AHAA Request
Study date
20 February 2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
305878
Title
Section 159(1)(a) Notice of requirement of information, report or sample
Study date
29/05/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
304278
Title
Updated formulation details
Study date
20 February 2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia