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

142671
Product/Active constituent Name

Application Product Name

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE XL: 31.6 MG ATINVICITINIB

Application details

Product name:

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE XL: 31.6 MG ATINVICITINIB

Product number:

94528

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Date

Application Date

Application No

Application Number

142673
Product/Active constituent Name

Application Product Name

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE L: 21.6 MG ATINVICITINIB

Application details

Product name:

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE L: 21.6 MG ATINVICITINIB

Product number:

94530

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Date

Application Date

Application No

Application Number

142674
Product/Active constituent Name

Application Product Name

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE M: 7.2 MG ATINVICITINIB

Application details

Product name:

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE M: 7.2 MG ATINVICITINIB

Product number:

94531

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Date

Application Date

Application No

Application Number

142676
Product/Active constituent Name

Application Product Name

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE S: 4.8 MG ATINVICITINIB

Application details

Product name:

ATINVICITINIB 30 MG/G ORAL TABLETS FOR DOGS, SIZE S: 4.8 MG ATINVICITINIB

Product number:

94532

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of 30 g/kg Atinvicitinib Oral Tablets for Dogs for the control of pruritus associated with allergic and atopic dermatitis in dogs in conjunction with approval of the active constituent Atinvicitinib.
Date

Application Date

Application No

Application Number

142178
Product/Active constituent Name

Application Product Name

MASTIPLAN L.C. BROAD SPECTRUM LACTATING COW TREATMENT

Application details

Product name:

MASTIPLAN L.C. BROAD SPECTRUM LACTATING COW TREATMENT

Product number:

94354

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 300mg cephapirin and 20 mg prednisolone as a homogeneous, sterile suspension intramammary product for the treatment of mastitis in lactating cows.

Reference details:

47091 - METRICURE BENZATHINE CEPHAPIRIN INTRA-UTERINE SUSPENSION
Date

Application Date

Application No

Application Number

142031
Product/Active constituent Name

Application Product Name

Barricade GR Herbicide

Application details

Product name:

Barricade GR Herbicide

Product number:

94295

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 20 g/kg prodiamine granular product for use in garden beds and nursery pots for pre-emergent control of weeds.

Reference details:

62982 - BARRICADE HERBICIDE
Date

Application Date

Application No

Application Number

141670
Product/Active constituent Name

Application Product Name

Restrain

Application details

Product name:

Restrain

Product number:

94136

Applicant Name:

RESTRAIN COMPANY LIMITED

Application purpose and description of use:

Registration of a catalytic ethylene generator (GE) product for: 1, the pre-harvest ripening of tomatoes and bell peppers 2, the post-harvest anti sprouting treatment of potatoes, onions, garlic & shallots during extended storage
Date

Application Date

Application No

Application Number

141873
Product/Active constituent Name

Application Product Name

Certainty Herbicide

Application details

Product name:

Certainty Herbicide

Product number:

94233

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

Registration of a 750 g/kg sulfosulfuron water dispersible granule (WG) product for the control of Sedges (Kyllinga, Mullumbimby Couch & Nutgrass) in Turf
Date

Application Date

Application No

Application Number

141514
Product/Active constituent Name

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

141516
Product/Active constituent Name

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 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 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 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
Author
Not specified
Title
Active assay method
Study date
2023
Authorising party
Applicant
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
307894
Author
Moore and Frimberger
Title
Usefulness of chemotherapy for the treatment of very elderly dogs with multicentric lymphoma
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
306398
Author
Not specified
Title
Excipient CoA
Study date
2024
Authorising party
Applicant
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306401
Author
Not specified
Title
Finished product specifications
Study date
2026
Authorising party
Applicant
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
307892
Author
Anon
Title
Explanation
Study date
2026
Authorising party
Applicant
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
307893
Author
Anon
Title
Summary report
Study date
2025
Authorising party
Applicant
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306399
Author
Not specified
Title
Active assay method validation
Study date
2023
Authorising party
Applicant
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306402
Author
Not specified
Title
Photostability study
Study date
2023
Authorising party
Applicant
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 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 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

139563
Product/Active constituent Name

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 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
Author
M. Langereis
Title
063344: Report determination of residual plasmid DNA in antigen batches. (See also 2.H.6.11)
Study date
30 April 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306323
Author
Anon
Title
CoA batch 0001301510
Study date
8 December 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306377
Author
Anon
Title
CEP 2000-119
Study date
22 September 2015
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306231
Author
E. Versmissen
Title
PDP-E/0035/18: Report study to investigate the dissemination of antigen strain in ferrets
Study date
30 September 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306340
Author
Anon
Title
CoA batch 2198213-02
Study date
15 October 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306291
Author
B. Bruton
Title
PDP-E/0114/15: Report dissemination study of antigen strain. (See also 3.E.6.40)
Study date
22 January 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306389
Author
Anon
Title
TSE statement re BSE
Study date
January 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306317
Author
K.W.R. van Cleef
Title
20R/0052: Process validation report of CPV antigen passage production at TCB
Study date
7 April 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306366
Author
Anon
Title
CEP 2001-024
Study date
30 January 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306346
Author
Anon
Title
CoA batch 7101832
Study date
20 April 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306297
Author
MSD
Title
PDP-E/0019-15 Addendum to report at 5.B.17 (and at 3.E.6.32)
Study date
1 August 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306360
Author
Anon
Title
CEP 2000-211
Study date
7 December 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306254
Author
N.M. Greenwood
Title
PDP-E/0047/15: Report safety/reversion to virulence study. (See also 3.E.6.33)
Study date
12 July 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306303
Author
J. Pearce
Title
CoA CPC13.20.201A
Study date
22 July 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306354
Author
Anon
Title
CEP 2000-155 (see also S0825-2_V1_1.A.Annex 5.12.2.4)
Study date
3 May 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306234
Author
L. Peeters
Title
PDP-E/0012/17: Report disinfection of antigen strain contaminated animal facilities
Study date
29 January 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306374
Author
Anon
Title
CEP 2005-050
Study date
27 February 2013
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306334
Author
E. van Loenen
Title
08R/0236: Report detection infectious BVD in bovine sera
Study date
26 September 2008
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306326
Author
Anon
Title
CoA batch 500717-2
Study date
30 August 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306380
Author
Anon
Title
CEP 2002-183
Study date
12 April 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306363
Author
Anon
Title
CEP 2000-384
Study date
14 March 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306337
Author
Anon
Title
Annotated schematic of plasmid
Study date
October 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306343
Author
J.J. van Beveren-Luteijn
Title
Move from product to active data item was 253640
Study date
18 October 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306314
Author
G. van der Heijden
Title
16R/0259: Validation Report of mycoplasma PCR for antigen
Study date
30 November 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306320
Author
Anon
Title
Data sheet IgG FITC
Study date
October 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306294
Author
B. Bruton
Title
PDP-E/0119/15: Report thymus safety study - overdose of antigen. (See also 3.E.6.32)
Study date
14 March 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306357
Author
Anon
Title
CEP 2000-173
Study date
3 May 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306300
Author
MSD
Title
PDP-E/0047/15: Study protocol reversion to virulence
Study date
17 June 2015
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306352
Author
Anon
Title
CEP 2000-080
Study date
3 April 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306375
Author
Anon
Title
CEP 2005-087
Study date
1 August 2013
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306235
Author
C. Aben
Title
14R/0009: Report validation of chemical disinfection of virus families used within animal health
Study date
17 December 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306369
Author
Anon
Title
CEP 2001-032
Study date
3 May 2010
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306381
Author
Anon
Title
CEP 2003-172
Study date
24 October 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306321
Author
W. Bardoel
Title
Data sheet B2G11-INT
Study date
31 March 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306335
Author
J. Pearce
Title
PDP-E-0084-15: Report genetic characterisation of master material plasmid
Study date
19 October 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306229
Author
B. Bruton
Title
PDP-E/0114/15: Report dissemination of antigen strain. (See also 5.B.3)
Study date
22 January 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306329
Author
Anon
Title
CoA batch AM1359671
Study date
2 February 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306295
Author
MSD
Title
SOP/EXP.2188E: Clinical monitoring - recording of clinical signs
Study date
25 May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306338
Author
Anon
Title
CoA DL795
Study date
2 September 1998
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306358
Author
Anon
Title
CEP 2000-187
Study date
6 March 2006
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306309
Author
J. Pearce
Title
CoA antigen #1896
Study date
2 July 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306372
Author
Anon
Title
CEP 2001-181
Study date
29 June 2007
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306332
Author
Anon
Title
CoA batch 001903
Study date
24 November 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306232
Author
N. Greenwood
Title
PDP-E/0084/15: Report genetic characterisation of antigen used in registration studies. (See also 5.B.21)
Study date
21 August 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306378
Author
Anon
Title
CEP 2000-140
Study date
12 October 2010
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306361
Author
Anon
Title
CEP 2000-294
Study date
23 April 2007
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306318
Author
C. Brands
Title
16R/0188: Report transfer of titration of CPV antigen
Study date
19 October 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306292
Author
S. Chalmers
Title
SAV/AAa/1: Report reversion to virulence of vaccine virus component
Study date
21 August 1996
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306341
Author
Anon
Title
CoA batch 19K225303
Study date
27 August 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306312
Author
S. Demaret, N. Visser
Title
98R/0421: Report on efficacy of treatment of ingredient in relation to inactivation of added PCV
Study date
29 May 1998
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306298
Author
PDP-E/0084/15: DOI report - genetic characterisation of antigen used in registration studies. (See also 3.E.43)
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
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306349
Author
Anon
Title
CoA batch PG15381
Study date
5 January 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306355
Author
Anon
Title
CEP 2000-171
Study date
3 May 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306233
Author
J. Pearce
Title
Memo 19102017: The genetic characterisation of master seed material plasmid
Study date
19 October 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306227
Author
J. Pearce
Title
CPV study - Report CAP-E/0170/11 Assessment of early OOI
Study date
19 April 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306333
Author
D. Weppner, J. Daley, J. Jensen & M. Plavsic
Title
Validation study Effectiveness of virus inactivation by gamma-irradiation
Study date
17 April 1998
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306373
Author
Anon
Title
CEP 2001-190
Study date
7 December 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306379
Author
Anon
Title
CEP 2000-312
Study date
27 March 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306327
Author
Anon
Title
CoA batch CRS060917-3
Study date
9 November 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306293
Author
J. Pearce
Title
Move from product to active was data item 253470
Study date
6 December 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306364
Author
Anon
Title
CEP 2000-387
Study date
29 May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306387
Author
Anon
Title
TSE statement LP0048B
Study date
23 May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306313
Author
H. Raes
Title
10R/0073: Validation Report of mycoplasma PCR
Study date
27 January 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306344
Author
Anon
Title
MCS 19570-001 karyology and identity information on master cell stock
Study date
25 July 1999
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306301
Author
MSD
Title
PDP-E/0114/15: Study protocol dissemination of antigen strain
Study date
5 October 2015
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306350
Author
Anon
Title
CoA batch B201-500 buffer lot AVH77720
Study date
11 October 2010
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306356
Author
Anon
Title
CEP 2000-172
Study date
3 May 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306376
Author
Anon
Title
CEP 2000-044
Study date
12 April 2012
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306370
Author
Anon
Title
CEP 2001-093
Study date
16 April 2007
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306324
Author
Anon
Title
CoA batch 1320027491
Study date
10 February 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306336
Author
MSD
Title
CoA batch 30D15 ref 515274-2 of plasmid
Study date
6 August 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306330
Author
Anon
Title
CoA batch MB1909482
Study date
2 February 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306230
Author
L. Peeters
Title
PDP-E/0098/17: Report disinfection of antigen strain contaminated animal facilities
Study date
14 May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306367
Author
Anon
Title
CEP 2001-030
Study date
13 November 2006
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306316
Author
M. Langereis
Title
063344: Report on determination of residual plasmid DNA in CPV antigen batches. (See also 3.E.6.48)
Study date
30 April 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306390
Author
Anon
Title
TSE statement no TSE risk
Study date
18 May 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306310
Author
J. Pearce
Title
CoA antigen #1897
Study date
2 July 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306347
Author
Anon
Title
CoA batch 6193722
Study date
26 July 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306304
Author
J. Pearce
Title
CoA antigen CPC106S
Study date
11 November 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306353
Author
Anon
Title
CEP 2000-089
Study date
25 January 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306371
Author
Anon
Title
CEP 2001-137
Study date
13 September 2011
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306325
Author
Anon
Title
CoA batch 22301119
Study date
22 November 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306331
Author
Anon
Title
CoA batch RNBG0655
Study date
5 June 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306391
Author
MSD Animal Health
Title
Certificates of suitability
Study date
Feb 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306319
Author
M. van den Berg
Title
Data sheet A2F8-INT
Study date
29 July 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306362
Author
Anon
Title
CEP 2000-309
Study date
27 February 2007
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306368
Author
Anon
Title
CEP 2001-031
Study date
13 November 2006
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306342
Author
Anon
Title
CoO batch 091M7012V and CEP
Study date
27 October 2014
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306299
Author
MSD
Title
Move from product to active was data item 253487
Study date
24 November 2015
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306311
Author
B. Cook
Title
CAP-E/0071/13: Report sequence determination CPV masterseed virus
Study date
15 August 2013
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306348
Author
Anon
Title
CoA batch 145948
Study date
14 February 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306305
Author
J. Pearce
Title
CoA antigen #1894
Study date
2 July 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306236
Author
C. Aben
Title
14R/0010: Report validation of thermal inactivation for various virus families in suspension
Study date
13 January 2014
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306228
Author
J. Pearce
Title
Memo 03042020 - over-attenuation of antigen strain at higher passages in cell culture
Study date
3 April 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306322
Author
M. van den Ilerik
Title
CoA Q-AB138486
Study date
30 March 2020
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306328
Author
Anon
Title
CoA batch K52534476
Study date
2 February 2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306388
Author
Anon
Title
TSE statement AS 5X59039
Study date
13 December 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306296
Author
MSD
Title
SOP/EXP.2190E: In-house clinical scoring system
Study date
7 February 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306339
Author
Anon
Title
Product specification P6463
Study date
October 2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306365
Author
Anon
Title
CEP 2000-392
Study date
11 August 2017
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306345
Author
Anon
Title
CoA batch 7H2161
Study date
12 December 1997
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306359
Author
Anon
Title
CEP 2000-188
Study date
10 March 2006
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306302
Author
J. Pearce
Title
CoA 22E18
Study date
11 September 2018
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306351
Author
Anon
Title
CEP 2000-076
Study date
25 November 2016
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

139403
Product/Active constituent Name

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 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 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.