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
141514
Product/Active constituent Name
Application Product Name
verdinexor
Application Date
Application Number
141514
Application Product Name
verdinexor
Application details
Product name:
verdinexor
Product number:
94091
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 50 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date
Application Date
Application No
Application Number
141515
Product/Active constituent Name
Application Product Name
Laverdia 50 mg Tablets for Dogs
Application Date
Application Number
141515
Application Product Name
Laverdia 50 mg Tablets for Dogs
Application details
Product name:
Laverdia 50 mg Tablets for Dogs
Product number:
94092
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 50 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date
Application Date
Application No
Application Number
141516
Product/Active constituent Name
Application Product Name
Laverdia 22.5 mg Tablets for Dogs
Application Date
Application Number
141516
Application Product Name
Laverdia 22.5 mg Tablets for Dogs
Application details
Product name:
Laverdia 22.5 mg Tablets for Dogs
Product number:
94093
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 22.5 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date
Application Date
Application No
Application Number
141517
Product/Active constituent Name
Application Product Name
Laverdia 10 mg Tablets for Dogs
Application Date
Application Number
141517
Application Product Name
Laverdia 10 mg Tablets for Dogs
Application details
Product name:
Laverdia 10 mg Tablets for Dogs
Product number:
94094
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 10 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of
verdinexor.
Date
Application Date
Application No
Application Number
141518
Product/Active constituent Name
Application Product Name
Laverdia 2.5 mg Tablets for Dogs
Application Date
Application Number
141518
Application Product Name
Laverdia 2.5 mg Tablets for Dogs
Application details
Product name:
Laverdia 2.5 mg Tablets for Dogs
Product number:
94095
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 2.5 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of
verdinexor.
Date
Application Date
Application No
Application Number
141352
Product/Active constituent Name
Application Product Name
Actavan® Bio Plant Defence Elicitor
Application Date
Application Number
141352
Application Product Name
Actavan® Bio Plant Defence Elicitor
Application details
Product name:
Actavan® Bio Plant Defence Elicitor
Product number:
94052
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 900 g/L Beet Extract product that is a natural elicitor that enhances the plant defences in Vine grapes increasing their resistance to Botrytis infection in conjunction with approval of Beet Extract active constituent..
Reference details:
94051 - Sugar beet
Date
Application Date
Application No
Application Number
141351
Product/Active constituent Name
Application Product Name
Sugar beet
Application Date
Application Number
141351
Application Product Name
Sugar beet
Application details
Product name:
Sugar beet
Product number:
94051
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 900 g/L Beet Extract product that is a natural elicitor that enhances the plant defences in Vine grapes increasing their resistance to Botrytis infection in conjunction with approval of Beet Extract active constituent..
Date
Application Date
Application No
Application Number
141132
Product/Active constituent Name
Application Product Name
IMTRADE ARCHITECT RMR INSECTICIDE
Application Date
Application Number
141132
Application Product Name
IMTRADE ARCHITECT RMR INSECTICIDE
Application details
Product name:
IMTRADE ARCHITECT RMR INSECTICIDE
Product number:
93979
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 50g/L EMAMECTIN present as Emamectin Benzoate + 150g/L PIPERONYL BUTOXIDE emulsifiable concentrate product for the control of various Lepidopteran Pests Cotton, Canola, Pulses, Brassica Vegetables, Capsicum, Lettuce, Grapes, Sweetcorn and Tomatoes as specified in the Directions for Use table.
Reference details:
51321 - AFFIRM INSECTICIDE
50919 - PROCLAIM INSECTICIDE
92346 - IMTRADE ACTIVIST 225 VERIPHY SL INSECTICIDE
85276 - IMTRADE ELLIAS 300 EC INSECTICIDE
Date
Application Date
Application No
Application Number
140723
Product/Active constituent Name
Application Product Name
Diflufenican
Application Date
Application Number
140723
Application Product Name
Diflufenican
Application details
Product name:
Diflufenican
Active name:
Diflufenican
Applicant Name:
AGROBEATS TECH CO. LTD.
Application purpose and description of use:
Approval of Diflufenican for use in agricultural chemical products.
Date
Application Date
Application No
Application Number
139562
Product/Active constituent Name
Application Product Name
CANINE DISTEMPER VIRUS (CDV), Strain Onderstepoort
Application Date
Application Number
139562
Application Product Name
CANINE DISTEMPER VIRUS (CDV), Strain Onderstepoort
Application details
Product name:
CANINE DISTEMPER VIRUS (CDV), Strain Onderstepoort
Product number:
93570
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a live vaccine for active immunisation of puppies from 4 weeks of age onwards, in conjunction with the approval of live recombinant canine parvovirus strain 630a.
Description of data provided:
Data no
304525
Title
CoA batch 6193722
Study date
26 July 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304548
Title
CEP 2001-137 certificate of suitability for starting material A
Study date
13 September 2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304554
Title
TSE statement AS 5X59039
Study date
13 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304537
Title
CEP 2000-211 certificate of suitability for starting material A
Study date
7 December 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304531
Title
CEP 2000-155 certificate of suitability for starting material A (see also S0825-2_V1_1.A.Annex 5.12.2.4)
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304551
Title
CEP 2005-050 certificate of suitability for starting material A
Study date
27 February 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304528
Title
CEP 2000-076 certificate of suitability for starting material A
Study date
25 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304545
Title
CEP 2001-031 certificate of suitability for starting material A
Study date
13 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304522
Title
111287 karyology and identity - information on master cell stock
Study date
13 August 1995
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304557
Title
SOP TI-5089-0002
Study date
Oct 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304534
Title
CEP 2000-173 certificate of suitability for starting material A
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304552
Title
CEP 2005-087 certificate of suitability for starting material A
Study date
1 August 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304523
Title
Duplicate of 253639
Study date
12 December 1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304546
Title
CEP 2001-032 certificate of suitability for starting material A
Study date
3 May 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304517
Title
Test Report CDV MS 030692
Study date
17 September 1992
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304543
Title
CEP 2001-024 certificate of suitability for starting material A
Study date
30 January 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304529
Title
CEP 2000-080 certificate of suitability for starting material A
Study date
3 April 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304526
Title
CoA batch 145948
Study date
14 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304549
Title
CEP 2001-181 certificate of suitability for starting material A
Study date
29 June 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304520
Title
CoA working seed virus
Study date
21 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304540
Title
CEP 2000-384 certificate of suitability for starting material A
Study date
14 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304532
Title
CEP 2000-171 certificate of suitability for starting material A
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304521
Title
Master seed test results on master cell stock batch 111287 - information on master cell stock
Study date
7 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304541
Title
CEP 2000-387 certificate of suitability for starting material A
Study date
29 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304535
Title
CEP 2000-187 certificate of suitability for starting material A
Study date
6 March 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304547
Title
CEP 2001-093 certificate of suitability for starting material A
Study date
16 April 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304524
Title
CoA batch 7101832
Study date
20 April 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304555
Title
TSE statement re BSE
Study date
January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304538
Title
CEP 2000-294 certificate of suitability for starting material A
Study date
23 April 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304518
Title
CoA batch 22301119
Study date
22 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304544
Title
CEP 2001-030 certificate of suitability for starting material A
Study date
13 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304550
Title
CEP 2001-190 certificate of suitability for starting material A
Study date
7 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304527
Title
CoA batch PG15381
Study date
CoA batch PG15381
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304556
Title
TSE statement no TSE
Study date
18 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304539
Title
CEP 2000-309 certificate of suitability for starting material A
Study date
27 February 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304519
Title
Master seed virus protocol batch 501-032201
Study date
20 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304533
Title
CEP 2000-172 certificate of suitability for starting material A
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304553
Title
TSE statement LP0048B
Study date
23 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304516
Title
SAV/AAa/1: Report reversion to virulence of vaccine virus component
Study date
S. Chalmers
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304542
Title
CEP 2000-392 certificate of suitability for starting material A
Study date
11 August 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304530
Title
CEP 2000-089 certificate of suitability for starting material A
Study date
25 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304536
Title
CEP 2000-188 certificate of suitability for starting material A
Study date
10 March 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
139563
Product/Active constituent Name
Application Product Name
NOBIVAC PUPPY DP PLUS LIVE VACCINE
Application Date
Application Number
139563
Application Product Name
NOBIVAC PUPPY DP PLUS LIVE VACCINE
Application details
Product name:
NOBIVAC PUPPY DP PLUS LIVE VACCINE
Product number:
93571
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a live vaccine for active immunisation of puppies from 4 weeks of age onwards, in conjunction with the approval of live recombinant canine parvovirus strain 630a.
Date
Application Date
Application No
Application Number
139564
Product/Active constituent Name
Application Product Name
CANINE PARVOVIRUS Strain 630a
Application Date
Application Number
139564
Application Product Name
CANINE PARVOVIRUS Strain 630a
Application details
Product name:
CANINE PARVOVIRUS Strain 630a
Product number:
93572
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a live vaccine for active immunisation of puppies from 4 weeks of age onwards, in conjunction with the approval of live recombinant canine parvovirus strain 630a.
Date
Application Date
Application No
Application Number
139403
Product/Active constituent Name
Application Product Name
SA WATER COPPER SULPHATE ALGICIDE
Application Date
Application Number
139403
Application Product Name
SA WATER COPPER SULPHATE ALGICIDE
Application details
Product name:
SA WATER COPPER SULPHATE ALGICIDE
Product number:
51854
Applicant Name:
SOUTH AUSTRALIAN WATER CORPORATION
Application purpose and description of use:
Variation of product registration and/or label approval to (summarise proposed variation).
Date
Application Date
Application No
Application Number
138676
Product/Active constituent Name
Application Product Name
Nufarm Galaxy Herbicide
Application Date
Application Number
138676
Application Product Name
Nufarm Galaxy Herbicide
Application details
Product name:
Nufarm Galaxy Herbicide
Product number:
92149
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product label approval to include aerial application for the same crops, weeds controlled, application rates and tank mixes as currently registered for ground boom application.
Date
Application Date
Application No
Application Number
138134
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Enteritidis
Application Date
Application Number
138134
Application Product Name
Salmonella Enterica ser. Enteritidis
Application details
Product name:
Salmonella Enterica ser. Enteritidis
Product number:
93161
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138135
Product/Active constituent Name
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application Date
Application Number
138135
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application details
Product name:
AviPro Salmonella Duo Live Vaccine
Product number:
93162
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138136
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Typhimurium
Application Date
Application Number
138136
Application Product Name
Salmonella Enterica ser. Typhimurium
Application details
Product name:
Salmonella Enterica ser. Typhimurium
Product number:
93163
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138142
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application Date
Application Number
138142
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application details
Product name:
AviPro Salmonella Vac E Live Vaccine
Product number:
93166
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction
with approval of an active constituent.
Date
Application Date
Application No
Application Number
138146
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application Date
Application Number
138146
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application details
Product name:
AviPro Salmonella Vac T Live Vaccine
Product number:
93168
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of an active constituent (secondary application).
Date
Application Date
Application No
Application Number
136797
Product/Active constituent Name
Application Product Name
IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE
Application Date
Application Number
136797
Application Product Name
IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE
Application details
Product name:
IMTRADE MYRIAD RMR MITICIDE/INSECTICIDE
Product number:
92822
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 72g/L ABAMECTIN + 180g/L PIPERONYL BUTOXIDE emulsifiable concentrate product for the control of certain Mites and Insect Pests on a variety of crops along with Native Budworm and Bollworm on Cotton as as specified in the Directions for Use table.
Reference details:
53325 - IMTRADE ABACHEM 18 MITICIDE/INSECTICIDE
53695 - PUPPET INSECTICIDE SYNERGIST
67524 - VANTAL UPGRADE MITICIDE/INSECTICIDE
88914 - IMTRADE CYBORG PLUS 100 EC INSECTICIDE
91429 - IMTRADE PATRIARCH RMR INSECTICIDE
58463 - SYNERGY INSECTICIDE SYNERGIST
88596 - Pyrate Natural Insecticide