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
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
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.
Description of data provided:
Data no
306400
Title
Active assay method
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306398
Title
Excipient CoA
Study date
2024
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306401
Title
Finished product specifications
Study date
2026
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306399
Title
Active assay method validation
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306402
Title
Photostability study
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
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
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.
Description of data provided:
Data no
306237
Title
063344: Report determination of residual plasmid DNA in antigen batches. (See also 2.H.6.11)
Study date
30 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306323
Title
CoA batch 0001301510
Study date
8 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306377
Title
CEP 2000-119
Study date
22 September 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306231
Title
PDP-E/0035/18: Report study to investigate the dissemination of antigen strain in ferrets
Study date
30 September 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306340
Title
CoA batch 2198213-02
Study date
15 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306291
Title
PDP-E/0114/15: Report dissemination study of antigen strain. (See also 3.E.6.40)
Study date
22 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306389
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
306317
Title
20R/0052: Process validation report of CPV antigen passage production at TCB
Study date
7 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306366
Title
CEP 2001-024
Study date
30 January 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306346
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
306297
Title
PDP-E/0019-15 Addendum to report at 5.B.17 (and at 3.E.6.32)
Study date
1 August 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306360
Title
CEP 2000-211
Study date
7 December 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306254
Title
PDP-E/0047/15: Report safety/reversion to virulence study. (See also 3.E.6.33)
Study date
12 July 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306303
Title
CoA CPC13.20.201A
Study date
22 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306354
Title
CEP 2000-155 (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
306234
Title
PDP-E/0012/17: Report disinfection of antigen strain contaminated animal facilities
Study date
29 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306374
Title
CEP 2005-050
Study date
27 February 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306334
Title
08R/0236: Report detection infectious BVD in bovine sera
Study date
26 September 2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306326
Title
CoA batch 500717-2
Study date
30 August 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306380
Title
CEP 2002-183
Study date
12 April 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306363
Title
CEP 2000-384
Study date
14 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306337
Title
Annotated schematic of plasmid
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306343
Title
Move from product to active data item was 253640
Study date
18 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306314
Title
16R/0259: Validation Report of mycoplasma PCR for antigen
Study date
30 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306320
Title
Data sheet IgG FITC
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306294
Title
PDP-E/0119/15: Report thymus safety study - overdose of antigen. (See also 3.E.6.32)
Study date
14 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306357
Title
CEP 2000-173
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306300
Title
PDP-E/0047/15: Study protocol reversion to virulence
Study date
17 June 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306352
Title
CEP 2000-080
Study date
3 April 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306375
Title
CEP 2005-087
Study date
1 August 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306235
Title
14R/0009: Report validation of chemical disinfection of virus families used within animal health
Study date
17 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306369
Title
CEP 2001-032
Study date
3 May 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306381
Title
CEP 2003-172
Study date
24 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306321
Title
Data sheet B2G11-INT
Study date
31 March 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306335
Title
PDP-E-0084-15: Report genetic characterisation of master material plasmid
Study date
19 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306229
Title
PDP-E/0114/15: Report dissemination of antigen strain. (See also 5.B.3)
Study date
22 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306329
Title
CoA batch AM1359671
Study date
2 February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306295
Title
SOP/EXP.2188E: Clinical monitoring - recording of clinical signs
Study date
25 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306338
Title
CoA DL795
Study date
2 September 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306358
Title
CEP 2000-187
Study date
6 March 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306309
Title
CoA antigen #1896
Study date
2 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306372
Title
CEP 2001-181
Study date
29 June 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306332
Title
CoA batch 001903
Study date
24 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306232
Title
PDP-E/0084/15: Report genetic characterisation of antigen used in registration studies. (See also 5.B.21)
Study date
21 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306378
Title
CEP 2000-140
Study date
12 October 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306361
Title
CEP 2000-294
Study date
23 April 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306318
Title
16R/0188: Report transfer of titration of CPV antigen
Study date
19 October 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306292
Title
SAV/AAa/1: Report reversion to virulence of vaccine virus component
Study date
21 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306341
Title
CoA batch 19K225303
Study date
27 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306312
Title
98R/0421: Report on efficacy of treatment of ingredient in relation to inactivation of added PCV
Study date
29 May 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306298
Title
PDP-E/0084/15: DOI report - genetic characterisation of antigen used in registration studies. (See also 3.E.43)
Study date
21 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306349
Title
CoA batch PG15381
Study date
5 January 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306355
Title
CEP 2000-171
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306233
Title
Memo 19102017: The genetic characterisation of master seed material plasmid
Study date
19 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306227
Title
CPV study - Report CAP-E/0170/11 Assessment of early OOI
Study date
19 April 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306333
Title
Validation study Effectiveness of virus inactivation by gamma-irradiation
Study date
17 April 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306373
Title
CEP 2001-190
Study date
7 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306379
Title
CEP 2000-312
Study date
27 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306327
Title
CoA batch CRS060917-3
Study date
9 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306293
Title
Move from product to active was data item 253470
Study date
6 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306364
Title
CEP 2000-387
Study date
29 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306387
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
306313
Title
10R/0073: Validation Report of mycoplasma PCR
Study date
27 January 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306344
Title
MCS 19570-001 karyology and identity information on master cell stock
Study date
25 July 1999
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306301
Title
PDP-E/0114/15: Study protocol dissemination of antigen strain
Study date
5 October 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306350
Title
CoA batch B201-500 buffer lot AVH77720
Study date
11 October 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306356
Title
CEP 2000-172
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306376
Title
CEP 2000-044
Study date
12 April 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306370
Title
CEP 2001-093
Study date
16 April 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306324
Title
CoA batch 1320027491
Study date
10 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306336
Title
CoA batch 30D15 ref 515274-2 of plasmid
Study date
6 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306330
Title
CoA batch MB1909482
Study date
2 February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306230
Title
PDP-E/0098/17: Report disinfection of antigen strain contaminated animal facilities
Study date
14 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306367
Title
CEP 2001-030
Study date
13 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306316
Title
063344: Report on determination of residual plasmid DNA in CPV antigen batches. (See also 3.E.6.48)
Study date
30 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306390
Title
TSE statement no TSE risk
Study date
18 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306310
Title
CoA antigen #1897
Study date
2 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306347
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
306304
Title
CoA antigen CPC106S
Study date
11 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306353
Title
CEP 2000-089
Study date
25 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306371
Title
CEP 2001-137
Study date
13 September 2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306325
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
306331
Title
CoA batch RNBG0655
Study date
5 June 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306391
Title
Certificates of suitability
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306319
Title
Data sheet A2F8-INT
Study date
29 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306362
Title
CEP 2000-309
Study date
27 February 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306368
Title
CEP 2001-031
Study date
13 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306342
Title
CoO batch 091M7012V and CEP
Study date
27 October 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306299
Title
Move from product to active was data item 253487
Study date
24 November 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306311
Title
CAP-E/0071/13: Report sequence determination CPV masterseed virus
Study date
15 August 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306348
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
306305
Title
CoA antigen #1894
Study date
2 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306236
Title
14R/0010: Report validation of thermal inactivation for various virus families in suspension
Study date
13 January 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306228
Title
Memo 03042020 - over-attenuation of antigen strain at higher passages in cell culture
Study date
3 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306322
Title
CoA Q-AB138486
Study date
30 March 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306328
Title
CoA batch K52534476
Study date
2 February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306388
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
306296
Title
SOP/EXP.2190E: In-house clinical scoring system
Study date
7 February 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306339
Title
Product specification P6463
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306365
Title
CEP 2000-392
Study date
11 August 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306345
Title
CoA batch 7H2161
Study date
12 December 1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306359
Title
CEP 2000-188
Study date
10 March 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306302
Title
CoA 22E18
Study date
11 September 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306351
Title
CEP 2000-076
Study date
25 November 2016
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
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
134834
Product/Active constituent Name
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application Date
Application Number
134834
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application details
Product name:
Royal Canin Recovery Liquid Canine Feline
Product number:
92202
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Recovery Liquid Canine Feline', indicated for 'vet only' use in a critical care environment for dogs and cats.
Date
Application Date
Application No
Application Number
134836
Product/Active constituent Name
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application Date
Application Number
134836
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application details
Product name:
Royal Canin Gastrointestinal Low Fat Liquid Canine
Product number:
92204
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Gastrointestinal Low Fat Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Date
Application Date
Application No
Application Number
134837
Product/Active constituent Name
Application Product Name
Royal Canin Renal Support Liquid Canine
Application Date
Application Number
134837
Application Product Name
Royal Canin Renal Support Liquid Canine
Application details
Product name:
Royal Canin Renal Support Liquid Canine
Product number:
92205
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Renal Support Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Date
Application Date
Application No
Application Number
134838
Product/Active constituent Name
Application Product Name
Royal Canin Renal Support Liquid Feline
Application Date
Application Number
134838
Application Product Name
Royal Canin Renal Support Liquid Feline
Application details
Product name:
Royal Canin Renal Support Liquid Feline
Product number:
92206
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Renal Support Liquid Feline', indicated for 'vet only' use in a critical care environment for cats.
Date
Application No
Application Number
152765
Product/Active constituent Name
Application Product Name
PoolRx+ Mineral Algaecide
Application Number
152765
Application Product Name
PoolRx+ Mineral Algaecide
Application details
Product name:
PoolRx+ Mineral Algaecide
Product number:
97337
Applicant Name:
PoolRx Worldwide, Inc.
Application purpose and description of use:
Registration of a 216.7 g/kg COPPER present as COPPER SULFATE PENTAHYDRATE granular product for boosting the control of algae in chlorinated pools and spas.
Reference details:
89173 - Eezipool Smart Pool Booster Conditioner
40224 - POOL BLOCKS ALL SEASONS ALGICIDE
Description of data provided:
Data no
304897
Title
Laboratory Report
Study date
28/02/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304903
Title
Antimicrobial testing
Study date
13/4/2020
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304906
Title
Pool Blocks All Seasons Algicide 40224/1.5/0805
Study date
17/10/2005
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304900
Title
Antimicrobial testing
Study date
09/10/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304901
Title
Antimicrobial testing
Study date
12/12/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304892
Title
Information on ingredients
Study date
19/03/2026
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304898
Title
Part 2 Summary
Study date
April 2026
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304904
Title
PoolRx+ EPA registration number 79817-4
Study date
26/06/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304895
Title
Pool Units
Study date
13/11/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304907
Title
Part 8 Summary
Study date
April 2026
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304899
Title
Algaecide swimming pool field study
Study date
28/09/2021
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304896
Title
Safety Data Sheet
Study date
04/04/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304893
Title
Manufacturing process
Study date
13/11/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304905
Title
Eezipool Smart Pool Booster Conditioner 89173/135515
Study date
30/05/2022
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304894
Title
Final study report for the analysis of PoolRx+ for accelerated storage stability and corrosion characteristics.
Study date
12/10/2021
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304902
Title
Antimicrobial testing
Study date
29/10/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304891
Title
Certificate of analysis
Study date
08/12/2024
Auth party contact address
1120 Via Callejon San Clemente United States