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

154188
Product/Active constituent Name

Application Product Name

Impala Fungicide

Application details

Product name:

Impala Fungicide

Product number:

80146

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

To update and add additional descriptive text to label.

Reference details:

80146 - Impala Fungicide

Active constituents:

Active constituent name
63782 - AZOXYSTROBIN
Active constituent name
69141 - TRITICONAZOLE
Date

Application Date

Application No

Application Number

154861
Product/Active constituent Name

Application Product Name

XYLAZINE HYDROCHLORIDE

Application details

Product name:

XYLAZINE HYDROCHLORIDE

Active name:

XYLAZINE HYDROCHLORIDE

Applicant Name:

AUSRICHTER PTY LTD

Application purpose and description of use:

Approval of xylazine hydrochloride for use in veterinary chemical products.

Description of data provided:

Data no
308805
Author
Not identified
Title
Elemental impurities risk assessment
Study date
2024
Authorising party
Applicant
Auth party contact address
CAMPERDOWN MEWS 2/21 CHESTER ST CAMPERDOWN Australia
Data no
308803
Author
Anon
Title
Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
CAMPERDOWN MEWS 2/21 CHESTER ST CAMPERDOWN Australia
Data no
308804
Author
Anon
Title
Certificate
Study date
2015
Authorising party
Applicant
Auth party contact address
CAMPERDOWN MEWS 2/21 CHESTER ST CAMPERDOWN Australia
Date

Application Date

Application No

Application Number

153159
Product/Active constituent Name

Application Product Name

VANIVA 450SC TYMIRIUM technology Nematicide

Application details

Product name:

VANIVA 450SC TYMIRIUM technology Nematicide

Product number:

91437

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of label approval to include use on carrots and sweet potato, add disease claims, vary the plant back period for all rotational crops and revise label instructions.

Active constituents:

Active constituent name
91435 - CYCLOBUTRIFLURAM

Description of data provided:

Data no
309912
Author
Dart, I. and Faint, M
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2021/22.
Study date
21 July 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309935
Author
Kirchner, G.
Title
Evaluation of a nematicide in tomato. Childers, Queensland. 2020.
Study date
20 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309881
Author
Banman, C.
Title
SYN549522 SC (A22011B) - Magnitude of the Residue in Cucumber as a Representative Fruiting Vegetable Rotational Crop USA 2022
Study date
27 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309958
Author
Chen, J., Ma, J., Gao, F.,Tang, W., Yang, D., Zhang, C., Liang, Z., Xie, Y. and Sun, H.
Title
Evaluation of nematicides for Meloidogyne enterolobii management in sweetpotato.
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
309927
Author
Coster, S. Villalta, O. and Lopresti, J.
Title
Evaluation of a nematicide in zucchini. Farraday, Victoria. 2022/23.
Study date
27 June 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309918
Author
Faint, M.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2024/25.
Study date
6 June 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309921
Author
Tancred, S.
Title
Evaluation of a nematicide in tomato. Stanthorpe, Queensland. 2022/23.
Study date
13 June 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309898
Author
McDougall, L.
Title
Evaluation of a nematicide in carrot. Myalup, Western Australia. 2020.
Study date
11 January 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309892
Author
Paula Piedade Rabello
Title
SYN549522 - Validation of Analytical Methods GRM076.07A and GRM076.11A for the Determination of Residues of SYN549522 and Its Metabolites SYN510275, SYN510260 and Conjugated SYN549104 in Crops by LC-MS/MS
Study date
23 September 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309904
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in carrot. Guatemala. 2023/24.
Study date
4 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309941
Author
Fazza, A.
Title
Evaluation of a nematicide in carrot. Brazil. 2019.
Study date
31 August 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309947
Author
Hodgson-Kratky. K. and Pengelly, S.
Title
Evaluation of a nematicide in rockmelon. Gatton, Queensland. 2022/23.
Study date
3 August 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309884
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Magnitude of the Residues in or on Potatoes, Canada 2021
Study date
28 May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309955
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in capsicum. Guatemala. 2021.
Study date
23 December 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309915
Author
Myer. A. and Pengelly, S.
Title
Evaluation of a nematicide in sweet potato. Esk, Queensland. 2021/22.
Study date
22 May 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309878
Author
Syngenta
Title
Cyclobutrifluram ??? Appendix 1 ??? Rotational Crop Summaries
Study date
2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309924
Author
Myer. A. and Pengelly, S.
Title
Evaluation of a nematicide in zucchini. Moolboolaman, Queensland. 2020.
Study date
29 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309875
Author
C Banman
Title
SYN549522 FS (A22417B) and SYN549522 SC (A22011B) - Magnitude of the Residues in or on Carrot, Radish and Sugar Beet and Processed Commodities as Representative Crops of Root Vegetables Crop Subgroup 1A. USA 2021.
Study date
31 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309901
Author
Sargeant, M.
Title
Evaluation of a nematicide in carrot. Deniliquin, New South Wales. 2020/21.
Study date
28 October 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309938
Author
Allan, C.
Title
Evaluation of a nematicide in tomato. Manjimup, Western Australia. 2021.
Study date
22 July 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309895
Author
Vitelli, R.
Title
Part 8 ??? Efficacy and Crop Safety
Study date
30 January 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309944
Author
Cookson, L. and Watson, C.
Title
Evaluation of a nematicide in rockmelon. Bowen, Queensland. 2021.
Study date
29 April 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309933
Author
Faint, M
Title
Evaluation of a nematicide in tomato. Childers, Queensland. 2023.
Study date
6 September 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309910
Author
Themsen, C and Parker, D.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2021.
Study date
10 March 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309887
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Cereal Grains (Crop Groups 15 and 16) as Rotational Crops, USA 2021
Study date
24 May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309956
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in capsicum. Guatemala. 2021.
Study date
9 March 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309879
Author
Banman, C.
Title
SYN549522 SC (A22011B) ??? Magnitude of the Residue in or on Strawberries Following Soil Application, USA 2021
Study date
28 September 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309916
Author
Faint, M.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2024/25.
Study date
13 February 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309876
Author
T Ranchodbhai
Title
Determination of residues of SYN549522 and metabolites in sweet potatoes following applications of A22011B
Study date
21 August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309939
Author
Xiao, S.
Title
Evaluation of a nematicide in carrot. Lancelin, Western Australia. 2022.
Study date
18 January 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309890
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Non-Grass Animal Feed Crops as Rotational Crops, USA 2021
Study date
26 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309896
Author
Xiao, S.
Title
Evaluation of a nematicide in carrot. Myalup, Western Australia. 2020.
Study date
10 June 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309930
Author
McLean, H.
Title
Evaluation of a nematicide in squash. United States of America. 2018.
Study date
9 August 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309936
Author
Hitchner, E.
Title
Evaluation of a nematicide in watermelon. United States of America. 2019.
Study date
28 October 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309953
Author
Aryl, S.
Title
Evaluation of a nematicide in tomato. United States of America. 2023.
Study date
27 November 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309959
Author
Flemming, A., Guest, M., Luksch, T., O????????Sullivan, A., Screpanti, C., Dumeunier, R., Gaberthuel, M., Godineau, E., Harlow, P., Jeanguenat, A., Kurtz, B., Maienfisch, P., Mondiere, R., Pierce, A., Slaats, B., Smejkal, T. and Loiseleur, O.
Title
TYMIRIUM???? technology: the discovery of Cyclobutrifluram,
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
309907
Author
Cordingly, N.
Title
Evaluation of a nematicide in carrot. Woodridge, Western Australia. 2024.
Study date
19 December 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309913
Author
Themsen, C and Parker, D.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2023.
Study date
16 February 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309919
Author
Tancred, S.
Title
Evaluation of a nematicide in tomato. Stanthorpe, Queensland. 2019/20.
Study date
3 June 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309873
Author
K Patterson
Title
Part 5A ??? Residues
Study date
15 March 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309922
Author
Landmeter, D.
Title
Evaluation of a nematicide in tomato. Thyra, New South Wales. 2021/22.
Study date
6 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309899
Author
McDougall, L.
Title
Evaluation of a nematicide in carrot. Myalup, Western Australia. 2021.
Study date
23 March 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309950
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in rockmelon. Guatemala. 2020.
Study date
8 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309942
Author
Coster, S. Braybrook, D. and Lopresti, J.
Title
Evaluation of a nematicide in zucchini. Farraday, Victoria. 2020/21.
Study date
8 June 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309893
Author
L Mayer
Title
Trifluoroacetic Acid - Analytical Method GRM092.02A for the Determination of Trifluoroacetic Acid in Crops
Study date
8 June 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309885
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Legume Vegetables as Rotational Crops, USA 2021
Study date
26 August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309954
Author
Ramirez, H.
Title
Evaluation of a nematicide in tomato. United States of America. 2023.
Study date
12 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309908
Author
Myer. A. and Pengelly, S.
Title
Evaluation of a nematicide in sweet potato. Windermere, Queensland. 2020/21.
Study date
10 May 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309931
Author
Faint, M
Title
Evaluation of a nematicide in tomato. Childers, Queensland. 2021.
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309914
Author
Themsen, C and Parker, D.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2023.
Study date
6 March 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309925
Author
Landmeter, D.
Title
Evaluation of a nematicide in zucchini. Shepperton, Victoria. 2022.
Study date
17 May 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309874
Author
T Ranchodbhai
Title
Determination of residues of SYN549522 and metabolites in carrots following applications of A22011B
Study date
21 August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309945
Author
Cookson, L. and Watson, C.
Title
Evaluation of a nematicide in rockmelon. Bowen, Queensland. 2021.
Study date
21 April 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309951
Author
Chen, J-W.
Title
Evaluation of a nematicide in cucumber. Taiwan. 2020.
Study date
13 April 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309902
Author
Sargeant, M.
Title
Evaluation of a nematicide in carrot. Deniliquin, New South Wales. 2021/22.
Study date
15 December 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309937
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in rockmelon. Guatemala. 2021.
Study date
13 September 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309894
Author
C Schoen, N Bullock, D Martyn
Title
Validation of Syngenta Analytical Method GRM092.02A for the Determination of Trifluoroacetic Acid in Crops
Study date
21 March 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309957
Author
Themsen, C and Parker, D.
Title
Evaluation of a nematicide crop safety in sweet potato. Bundaberg, Queensland. 2024.
Study date
8 August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309934
Author
English, P
Title
Evaluation of a nematicide in tomato. Bowen, Queensland. 2021.
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309911
Author
Faint, M.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2020.
Study date
19 June 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309888
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Oilseeds as Rotational Crops, USA, 2021
Study date
29 August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309905
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in carrot. Guatemala. 2023/24.
Study date
4 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309882
Author
Banman, C.
Title
SYN549522 FS (A22417B) and SYN549522 SC (A22011B) - Magnitude of the Residues in or on Carrot, Radish and Sugar Beet and Processed Commodities as Representative Crops of Root Vegetables Crop Subgroup 1A USA 2021
Study date
31 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309928
Author
Putra, B.
Title
Evaluation of a nematicide in cucumber. Indonesia. 2020.
Study date
15 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309891
Author
L Mayer
Title
SYN549522 - Analytical Method GRM076.11A for the Determination of Conjugated Metabolite SYN549104 in Crops
Study date
14 October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309948
Author
Tancred, S.
Title
Evaluation of a nematicide in tomato. Stanthorpe, Queensland. 2022/23.
Study date
24 July 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309883
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Magnitude of the Residues in or on Potatoes, USA 2021
Study date
2 May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309929
Author
Wu, C.
Title
Evaluation of a nematicide in cucumber. Taiwan. 2020.
Study date
12 June 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309906
Author
Ambridge, L.
Title
Evaluation of a nematicide in carrot. Amiens, Queensland. 2024/25.
Study date
23 January 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309920
Author
Tancred, S.
Title
Evaluation of a nematicide in tomato. Stanthorpe, Queensland. 2021/22.
Study date
9 July 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309923
Author
Cookson, L. and Watson, C.
Title
Evaluation of a nematicide in capsicum. Bowen, Queensland. 2021.
Study date
4 April 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309900
Author
Allingame, M.
Title
Evaluation of a nematicide in carrot. Myalup, Western Australia. 2019.
Study date
10 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309949
Author
Eguizabal, A. R.
Title
Evaluation of a nematicide in rockmelon. Guatemala. 2020.
Study date
8 March 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309943
Author
Coster, S. Villalta, O. and Lopresti, J.
Title
Evaluation of a nematicide in zucchini. Farraday, Victoria. 2021/22.
Study date
14 July 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309886
Author
Banman, C.
Title
SYN549522 FS (A22417B) Magnitude of the Residue in Celery as a Representative Bulb and Stem Vegetable Rotational Crop USA 2022
Study date
30 October 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309909
Author
Kirchner, G.
Title
Evaluation of a nematicide in sweet potato. Gooburrum, Queensland. 2019/20.
Study date
6 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309932
Author
Dart, I. and Faint, M
Title
Evaluation of a nematicide in tomato. Childers, Queensland. 2022.
Study date
11 October 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309880
Author
Banman, C.
Title
SYN549522 SC (A22011B) - Magnitude of the Residue in Head Lettuce, Cabbage and Broccoli as Representative Leafy Vegetable and Brassica Rotational Crops USA 2022
Study date
5 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309926
Author
Coster, S. Villalta, O. and Lopresti, J.
Title
Evaluation of a nematicide in zucchini. Farraday, Victoria. 2022/23.
Study date
29 June 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309917
Author
Themsen, C and Parker, D.
Title
Evaluation of a nematicide in sweet potato. Bundaberg, Queensland. 2024/25.
Study date
12 March 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309897
Author
Xiao, S.
Title
Evaluation of a nematicide in carrot. Myalup, Western Australia. 2021.
Study date
13 July 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309946
Author
Hinton, S.
Title
Evaluation of a nematicide in cucumber. North McLean, Queensland. 2022.
Study date
27 July 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309877
Author
A Thiel
Title
SYN549522 SC (A22011B) - Magnitude of the Residues in or on Sweet Potato Roots and Processed Commodities Following Soil Applications ??? USA and Canada, 2021
Study date
13 January 2025
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309903
Author
Sargeant, M.
Title
Evaluation of a nematicide in carrot. Deniliquin, New South Wales. 2019/20.
Study date
1 August 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309940
Author
Dellacqua, R.
Title
Evaluation of a nematicide in carrot. Brazil. 2019.
Study date
8 August 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309952
Author
Carrillo, J.
Title
Evaluation of a nematicide in watermelon. United States of America. 2023.
Study date
3 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
309889
Author
Baillargeon, M.
Title
SYN549522 SC (A22011B) ??? Grass Animal Feed Crops as Rotational Crops, USA 2021
Study date
3 May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

153676
Product/Active constituent Name

Application Product Name

SIMODIS PLINAZOLIN technology Insecticide

Application details

Product name:

SIMODIS PLINAZOLIN technology Insecticide

Product number:

89460

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add additional crops and pests.

Active constituents:

Active constituent name
89440 - ISOCYCLOSERAM

Description of data provided:

Data no
310319
Author
Australian Environment Agency Pty Ltd
Title
Revised modelling for risk to aquatic and sediment organisms in the Mackay/Whitsunday region
Study date
August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310313
Author
Laura Seastrum
Title
Isocycloseram (A21550L) ??? magnitude of the residues in or on raw agricultural commodities of celery, USA 2022
Study date
2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310333
Author
Stephen Tancred
Title
Evaluation of insecticide in mini capsicum, Stanthorpe, Queensland, 2020
Study date
Apr 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310310
Author
Sara Pengelly
Title
Determination of residues of SYN547407 and metabolites SYN549431 and SYN548569 in cucurbits following foliar applications of A21708E, Australia, 2019/2020
Study date
2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310316
Author
Jodie Pedrana
Title
APVMA - Pre-Application Assistance (PAA) Request Tier 2
Study date
2019
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310322
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in Gai Lan, Lefthand Branch, Queensland, 2025
Study date
Aug 2025
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310330
Author
Amr Hamed
Title
Evaluation of insecticide in kidney bean, Qalyubia, Egypt, 2021
Study date
Nov 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310317
Author
APVMA
Title
Pre-application Assistance - APVMA Written Assistance
Study date
2019
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310311
Author
Sara Pengelly
Title
Determination of residues of SYN547407 and metabolites SYN549431 and SYN548569 in fruiting vegetable fruit, juice, pomace and paste following foliar applications of A21708E, Australia, 2019/2020
Study date
2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310325
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in spinach, Lefthand Branch, Queensland, 2025
Study date
Jul 2025
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310331
Author
Saleh Medhat
Title
Evaluation of insecticide in kidney bean, Qalyubia, Egypt, 2022
Study date
Nov 2022
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310308
Author
Magdel Mellet
Title
HIA letter of consent
Study date
Apr 2026
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060 Australia
Data no
310314
Author
Chris Banman
Title
SYN547407 DC (A21708F) ??? magnitude of the residue in or on head lettuce, leaf lettuce, spinach, and mustard greens as representative crops of the leafy vegetable group, (crop group 4-16), USA 2017
Study date
2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310328
Author
Ryan Humann
Title
Evaluation of insecticide in celery, California, United States of America, 2017
Study date
Sep 2017
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310334
Author
Trinh Nguyen
Title
Evaluation of insecticide in eggplant, Angle Vale, South Australia, 2022
Study date
Apr 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310309
Author
Kathryn Adams
Title
Part 5A - Residues
Study date
Jun 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310323
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in pak choi, Lefthand Branch, Queensland, 2024
Study date
Aug 2024
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310329
Author
Chuanming Xu
Title
Evaluation of insecticide in celery, Yuxi, China, 2019
Study date
Oct 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310320
Author
Rob Vitelli
Title
Part 8 - Efficacy & Crop Safety
Study date
May 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310312
Author
Sara Pengelly
Title
Determination of Residues of SYNFOI21 (SYN547407) and its Metabolites following Three Foliar Applications in Celery, Australia, 2021-2023
Study date
2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310326
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in spinach, Lefthand Branch, Queensland, 2023
Study date
Mar 2024
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310332
Author
Tien Hoang Nguyen
Title
Evaluation of insecticide in tomato, Vinh Phuc, Vietnam, 2019
Study date
May 2019
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310307
Author
Kathryn Adams
Title
SIMODIS draft label - highlighted
Study date
May 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310315
Author
Chris Banman
Title
SYN547407 DC (A21708F) ??? magnitude of the residue in or on spinach processed commodities, USA 2019
Study date
2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310321
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in celery, Lefthand Branch, Queensland, 2022
Study date
Jun 2022
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310327
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in spinach, Lefthand Branch, Queensland, 2024
Study date
Jan 2025
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Data no
310335
Author
Trinh Nguyen
Title
Evaluation of insecticide in capsicum, Angle Vale, South Australia, 2022
Study date
Apr 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310318
Author
Kathryn Adams
Title
Part 7.2 - Ecotox
Study date
May 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
310324
Author
Chris Themsen and Dale Parker
Title
Evaluation of insecticide in silverbeet, Lefthand Branch, Queensland, 2023
Study date
Aug 2024
Authorising party
Horticulture Innovation Australia Limited
Auth party contact address
Level 7, 141 Walker Street, North Sydney NSW 2060, Australia
Date

Application Date

Application No

Application Number

154422
Product/Active constituent Name

Application Product Name

Garden Basics Weed Kill Concentrate

Application details

Product name:

Garden Basics Weed Kill Concentrate

Product number:

86968

Applicant Name:

PINEGRO PRODUCTS PROPRIETARY LIMITED

Application purpose and description of use:

Variation of product registration to change the formulation. Also a Notifiable Variation to update the list of manufacturing sites for the product (updating names and addresses of manufacturing sites).

Active constituents:

Active constituent name
62532 - GLYPHOSATE

Description of data provided:

Data no
310854
Author
Anon
Title
2.0 Chemistry Dossier
Study date
July 2026
Authorising party
Applicant
Auth party contact address
137 Main street Bacchus Marsh Australia
Data no
310857
Author
Anon
Title
Information List
Study date
July 2026
Authorising party
Applicant
Auth party contact address
137 Main street Bacchus Marsh Australia
Data no
310855
Author
Anon
Title
8.0 Efficacy & Safety Dossier
Study date
July 2026
Authorising party
Applicant
Auth party contact address
137 Main street Bacchus Marsh Australia
Data no
310853
Author
Anon
Title
1.0 Executive Summary
Study date
July 2026
Authorising party
Applicant
Auth party contact address
137 Main street Bacchus Marsh Australia
Data no
310856
Author
Anon
Title
1.1 List of Manufacturers
Study date
July 2026
Authorising party
Applicant
Auth party contact address
137 Main street Bacchus Marsh Australia
Date

Application Date

Application No

Application Number

154999
Product/Active constituent Name

Application Product Name

F10 Ready To Use Disinfectant

Application details

Product name:

F10 Ready To Use Disinfectant

Applicant Name:

HEALTH AND HYGIENE (PTY) LTD

Application purpose and description of use:

Registration of a 0.22 g/L benzalkonium chloride Ready-to-Use (already diluted) aqueous solution for use as cleaning and disinfection of hard surfaces, nonporous surfaces, air spaces, equipment, utensils and instruments in food, industrial, domestic and institutional areas.
Date

Application Date

Application No

Application Number

153182
Product/Active constituent Name

Application Product Name

Daxocox 200mg tablets for dogs

Application details

Product name:

Daxocox 200mg tablets for dogs

Product number:

97444

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 200mg enflicoxib tablet product for use in dogs.

Active constituents:

Active constituent name
95331 - Enflicoxib (INN)

Description of data provided:

Data no
305095
Author
L. Martinez
Title
Report BM-98/21
Study date
June 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305072
Author
M. Colombo
Title
Report AI-99/01-SN
Study date
October 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305118
Author
J. Sola
Title
Report 113518
Study date
November 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305089
Author
M. Serafini
Title
Report BM-01/18-SN
Study date
March 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305055
Author
Anon
Title
Quality Documentation Part 2A Qualitative Particulars
Study date
February 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305049
Author
Virbac
Title
Safety Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305149
Author
M. Salichs
Title
Report 123119
Study date
December 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305178
Author
Virbac
Title
Cover Letter
Study date
6 February 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305129
Author
I. Demestre
Title
Report T-99/05
Study date
March 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305086
Author
O. Szkuta
Title
Report A123936
Study date
December 2012
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305109
Author
R. Farran
Title
Report BM-10/24-SN
Study date
October 2011
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305158
Author
S. Puig
Title
Report BM-10/28
Study date
October 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305135
Author
H. Williams
Title
Report VX05LK
Study date
September 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305172
Author
Lees et al
Title
Pharmacokinetics, pharmacodynamics, toxicology and therapeutics of mavacoxib in the dog: a review
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
305066
Author
Anon
Title
Certificate of GMP
Study date
November 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305078
Author
I. Alvarez
Title
Report AI-99/12-SN
Study date
September 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305046
Author
Virbac
Title
Chemistry and Manufacture Summary Product
Study date
April 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305069
Author
Anon
Title
Quality Documentation Part 2C3 Packaging
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305092
Author
J. Sola
Title
Report 112218
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305115
Author
J. Sola
Title
Report 118419
Study date
November 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305138
Author
J. Zapatero
Title
Report CD-98/6369T
Study date
May 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305161
Author
J. Cendros
Title
Report PK_001_2018
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305098
Author
L. Martinez
Title
Report BM-99/03
Study date
July 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305152
Author
M. Salichs
Title
Report 136720
Study date
July 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305052
Author
Virbac
Title
Environment Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305132
Author
A.Guzman
Title
Report T-00/08
Study date
March 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305106
Author
L. Salgado et al
Title
Chirality, 16: 302-308
Study date
2004
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305155
Author
Toutin et al
Title
A pharmacokinetic / pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
305181
Author
Brown, D. C et al
Title
Power of treatment success definitions when the Canine Brief Pain Inventory is used to evaluate carprofen treatment for the control of pain and inflammation in dogs with osteoarthritis
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
305063
Author
Anon
Title
Quality Documentation Part 2D Control Tests
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305112
Author
A. Barlagne
Title
Report A186725
Study date
May 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305169
Author
H. Noguer
Title
Report EV-19/01-SN
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305175
Author
VICH
Title
Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products (VMPS) - Phase I
Study date
June 2000
Authorising party
Public
Auth party contact address
-
Data no
305126
Author
I. Demestre
Title
Report T-98/05
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305075
Author
D. Romenov
Title
Report 284110
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305047
Author
Virbac
Title
Chemistry and Manufacture Summary Active
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305070
Author
Anon
Title
Certificates of Analysis
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305141
Author
I. Demestre
Title
Report T-98/08
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305093
Author
M. Escriche
Title
Report BM-12/14
Study date
June 2014
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305187
Author
Anon
Title
Raw Data
Study date
2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305164
Author
P. Sarasola
Title
Report DA/197/C
Study date
December 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305101
Author
L. Martinez
Title
Report BM-00/02
Study date
April 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305147
Author
A. Arano
Title
Report CD-99/6507FD
Study date
April 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305107
Author
L. Martinez
Title
Report CD-98/6419FC
Study date
January 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305084
Author
M. Colombo
Title
Report FI-00/01-SN
Study date
January 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305058
Author
Anon
Title
Quality Documentation Part 2C1 Active
Study date
February 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305156
Author
A. Gomez
Title
Report BM-12/09-SN
Study date
April 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305133
Author
J. Zapatero
Title
Report CD-98/6359T
Study date
September 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305064
Author
Anon
Title
Quality Documentation Part 2G Other Information
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305113
Author
L. Martinez
Title
Report BM-98/22
Study date
July 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305184
Author
KuKanich, B et al
Title
Clinical pharmacology of nonsteroidal anti-inflammatory drugs in dogs
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
305121
Author
L. Martinez
Title
Report BM-00/16
Study date
March 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305127
Author
I. Demestre
Title
Report T-99/04
Study date
December 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305170
Author
M. Salichs
Title
Report EV-18/18
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305176
Author
European Medicines Agency
Title
Summary of Opinion
Study date
February 2021
Authorising party
Public
Auth party contact address
-
Data no
305144
Author
A. Arano
Title
Report CD-98/6397FD
Study date
March 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305167
Author
J. Cendros
Title
Report PK_001_2020
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305090
Author
J. Sola
Title
Report 111018
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305044
Author
Virbac
Title
Cover Letter
Study date
April 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305104
Author
L. Martinez
Title
Report BM-01/31-SN
Study date
April 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305150
Author
M. Salichs
Title
Report 123219
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305050
Author
Virbac
Title
Efficacy Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305153
Author
Sanderson et al
Title
Systematic review of the management of canine osteoarthritis
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
305081
Author
M. Colombo
Title
Report AI-99/04-SN
Study date
January 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305130
Author
I. Demestre
Title
Report T-99/03
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305110
Author
O. Peris
Title
Report S27766
Study date
July 2010
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305061
Author
Anon
Title
Quality Documentation Part 2C2 Starting Materials
Study date
February 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305087
Author
L. Martinez
Title
Report BM-99/19-SN
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305067
Author
Anon
Title
Quality Documentation Part 2F1 Stability Active
Study date
May 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305073
Author
I. Alvarez
Title
Report FBIO-01/01-SN
Study date
October 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305124
Author
A. Arano
Title
Report CD-98/6399FD
Study date
February 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305173
Author
European Medicines Agency
Title
CVMP assessment report for Daxocox (EMEA/V/C/005354/0000)
Study date
April 2021
Authorising party
Public
Auth party contact address
-
Data no
305168
Author
P. Sarasola
Title
Report ONDAX (DA/184/C and DA/197/C)
Study date
July 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305116
Author
M. Escriche
Title
Report BM-00/29-SN
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305139
Author
A. Rodriguez
Title
Report T-13/02
Study date
May 2015
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305162
Author
P. Sarasola
Title
Report DA/184/C
Study date
January 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305185
Author
KuKanich, B
Title
Geriatric Veterinary Pharmacology
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
305053
Author
Anon
Title
Certificate of GMP
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305045
Author
Virbac
Title
Application Summary
Study date
April 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305145
Author
A. Arano
Title
Report CD-98/6396FD
Study date
February 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305151
Author
M. Salichs
Title
Report 123019
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305099
Author
L. Martinez
Title
Report BM-00/01-SN
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305082
Author
M. Colombo
Title
Report AI-99/03-SN
Study date
June 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305105
Author
L. Martinez
Title
Report BM-01/20
Study date
December 2004
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305182
Author
Rausch-Derra, L et al
Title
A Prospective, Randomized, Masked, Placebo-Controlled Multisite Clinical Study of Grapiprant, an EP4 Prostaglandin Receptor Antagonist (PRA), in Dogs with Osteoarthritis
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
305088
Author
L. Martinez
Title
Report BM-01/16-SN
Study date
February 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305062
Author
Anon
Title
Quality Documentation Part 2C4 Starting Materials
Study date
December 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305125
Author
L. Martinez
Title
Report BM-99/30-SN
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305076
Author
P. Mendoza
Title
Report S40772
Study date
October 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305119
Author
L. Martinez
Title
Report BM-99/08
Study date
June 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305096
Author
L. Martinez
Title
Report BM-98/20
Study date
May 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305165
Author
S. Puig
Title
Report BM-16/39
Study date
October 2017
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305142
Author
A. Rodriguez
Title
Report T-13/01
Study date
April 2015
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305188
Author
Anon
Title
Raw Data
Study date
2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305102
Author
A. Rusca
Title
Report CRO-PK-01-48
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305056
Author
Anon
Title
Quality Documentation Part 2B Manufacture
Study date
February 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305148
Author
I. Hallett
Title
Report 0538/051-D6146
Study date
July 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305059
Author
Anon
Title
Appendix 2C.1-1 Active Substance Master File
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305108
Author
L. Martinez
Title
Report BM-99/16
Study date
April 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305179
Author
Carapeba, G.O.L et al
Title
Intra-Articular Hyaluronic Acid Compared to Traditional Conservative Treatment in Dogs with Osteoarthritis Associated with Hip Dysplasia
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
305085
Author
O. Szkuta
Title
Report A113483
Study date
October 2012
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305159
Author
J. Cendros
Title
Report BM-13/06-SN
Study date
May 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305136
Author
J. Zapatero
Title
Report CD-99/6639T
Study date
December 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305065
Author
Anon
Title
Quality Documentation Part 2E Finished Product Tests
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305079
Author
E. Andres
Title
Report SNEC-13/12-SN
Study date
May 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305122
Author
L. Martinez
Title
Report BM-00/09
Study date
March 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305128
Author
I. Demestre
Title
Report T-98/06
Study date
January 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305171
Author
Edamura et al
Title
Comparison of oral robenacoxib and carprofen for the treatment of osteoarthritis in dogs: a randomised clinical trial
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
305143
Author
A. Arano
Title
Report CD-98/6393FD
Study date
March 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305120
Author
A. Arano
Title
Report CD-98/6361FD
Study date
December 1998
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305166
Author
J. Cendros
Title
Report PK_001_2019
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305137
Author
J. Zapatero
Title
Report CD-99/6640T
Study date
December 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305091
Author
J. Sola
Title
Report 112318
Study date
October 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305103
Author
L. Martinez
Title
Report BM-01/24
Study date
August 2004
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305051
Author
Virbac
Title
Health Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305097
Author
L. Martinez
Title
Report BM-99-06-SN
Study date
October 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305060
Author
Anon
Title
Active Substance Master File
Study date
January 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305131
Author
J. Zapatero
Title
Report CD-98/6358T
Study date
December 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305180
Author
Brown, D. C et al
Title
Development and psychometric testing of an instrument designed to measure chronic pain in dogs with osteoarthritis
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
305154
Author
Innes et al
Title
Use of non-steroidal anti-inflammatory drugs for the treatment of canine osteoarthritis
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
305111
Author
L. Llames
Title
Report TH180077
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305160
Author
J. Cendros
Title
Report EV-013/09-SN
Study date
December 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305068
Author
Anon
Title
Quality Documentation Part 2F2 Stability Finished Product
Study date
November 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305080
Author
M. Colombo
Title
Report AI-99/13-SN
Study date
May 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305174
Author
Chemwatch
Title
Safety Data Sheet
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305074
Author
J. Buxens
Title
Report SNEC-13/11-SN
Study date
May 2014
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305123
Author
L. Martinez
Title
Report BM-99/15
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305048
Author
Virbac
Title
Efficacy and Safety Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305071
Author
L. Saavedra
Title
Detailed and Critical Summary on the Pharmaceutical Documentation
Study date
March 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305094
Author
S. Puig
Title
Report BM-12/13
Study date
June 2014
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305117
Author
L. Gombau
Title
Report AT18P2501-01
Study date
January 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305140
Author
A. Guzman
Title
Report T-98/07
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305163
Author
S. Puig
Title
Report BM-14/20
Study date
October 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305186
Author
Homedes, J et al
Title
A blinded, randomized and controlled multicenter field study investigating the safety and efficacy of long-term use of enflicoxib in the treatment of naturally occurring osteoarthritis in client-owned dogs
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
305054
Author
Anon
Title
Certificate of GMP
Study date
February 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305146
Author
A. Arano
Title
Report CD-98/6398FD
Study date
February 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305100
Author
L. Martinez
Title
Report BM-00/17
Study date
September 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305083
Author
M. Colombo
Title
Report AI-99/07-SN
Study date
March 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305177
Author
European Medicines Agency
Title
Summary of Product Characteristics
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
305057
Author
C.J.R. van Barneveld
Title
Appendic 2B.3-1
Study date
June 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305134
Author
J. Zapatero
Title
Report CD-98/6360T
Study date
January 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305157
Author
A. Gomez
Title
Report BM-12/10-SN
Study date
May 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305183
Author
Lascelles, B.D.X et al
Title
Guidelines for Safe and Effective Use of NSAIDs in Dogs
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
305077
Author
M. Colombo
Title
Report AI 99/06-SN
Study date
May 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305114
Author
M. Serafini
Title
Report BM-00/11
Study date
October 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

153183
Product/Active constituent Name

Application Product Name

Daxocox 140mg tablets for dogs

Application details

Product name:

Daxocox 140mg tablets for dogs

Product number:

97445

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 140mg enflicoxib tablet product for use in dogs.

Active constituents:

Active constituent name
95331 - Enflicoxib (INN)

Description of data provided:

Data no
305189
Author
Virbac
Title
Cover Letter
Study date
April 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305258
Author
L. Martinez
Title
Report BM-98/22
Study date
July 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305264
Author
L. Martinez
Title
Report BM-99/08
Study date
June 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305281
Author
J. Zapatero
Title
Report CD-99/6639T
Study date
December 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305212
Author
Anon
Title
Quality Documentation Part 2F1 Stability Active
Study date
May 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305235
Author
J. Sola
Title
Report 111018
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305195
Author
Virbac
Title
Efficacy Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305304
Author
J. Cendros
Title
Report BM-13/06-SN
Study date
May 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305241
Author
L. Martinez
Title
Report BM-98/20
Study date
May 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305252
Author
L. Martinez
Title
Report CD-98/6419FC
Study date
January 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305295
Author
M. Salichs
Title
Report 123219
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305298
Author
Sanderson et al
Title
Systematic review of the management of canine osteoarthritis
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
305201
Author
Anon
Title
Quality Documentation Part 2B Manufacture
Study date
February 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305278
Author
J. Zapatero
Title
Report CD-98/6359T
Study date
September 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305315
Author
M. Salichs
Title
Report EV-18/18
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305327
Author
Rausch-Derra, L et al
Title
A Prospective, Randomized, Masked, Placebo-Controlled Multisite Clinical Study of Grapiprant, an EP4 Prostaglandin Receptor Antagonist (PRA), in Dogs with Osteoarthritis
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
305221
Author
P. Mendoza
Title
Report S40772
Study date
October 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305272
Author
I. Demestre
Title
Report T-99/04
Study date
December 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305321
Author
European Medicines Agency
Title
Summary of Opinion
Study date
February 2021
Authorising party
Public
Auth party contact address
-
Data no
305261
Author
M. Escriche
Title
Report BM-00/29-SN
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305238
Author
M. Escriche
Title
Report BM-12/14
Study date
June 2014
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305215
Author
Anon
Title
Certificates of Analysis
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305192
Author
Virbac
Title
Chemistry and Manufacture Summary Active
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305209
Author
Anon
Title
Quality Documentation Part 2G Other Information
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305307
Author
P. Sarasola
Title
Report DA/184/C
Study date
January 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305284
Author
A. Rodriguez
Title
Report T-13/02
Study date
May 2015
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305255
Author
O. Peris
Title
Report S27766
Study date
July 2010
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305244
Author
L. Martinez
Title
Report BM-00/01-SN
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305292
Author
A. Arano
Title
Report CD-99/6507FD
Study date
April 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305301
Author
A. Gomez
Title
Report BM-12/09-SN
Study date
April 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305198
Author
Anon
Title
Certificate of GMP
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305232
Author
L. Martinez
Title
Report BM-99/19-SN
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305218
Author
I. Alvarez
Title
Report FBIO-01/01-SN
Study date
October 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305275
Author
I. Demestre
Title
Report T-99/03
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305318
Author
European Medicines Agency
Title
CVMP assessment report for Daxocox (EMEA/V/C/005354/0000)
Study date
April 2021
Authorising party
Public
Auth party contact address
-
Data no
305324
Author
Carapeba, G.O.L et al
Title
Intra-Articular Hyaluronic Acid Compared to Traditional Conservative Treatment in Dogs with Osteoarthritis Associated with Hip Dysplasia
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
305224
Author
E. Andres
Title
Report SNEC-13/12-SN
Study date
May 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305239
Author
S. Puig
Title
Report BM-12/13
Study date
June 2014
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305216
Author
L. Saavedra
Title
Detailed and Critical Summary on the Pharmaceutical Documentation
Study date
March 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305287
Author
A. Rodriguez
Title
Report T-13/01
Study date
April 2015
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305233
Author
L. Martinez
Title
Report BM-01/16-SN
Study date
February 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305310
Author
S. Puig
Title
Report BM-16/39
Study date
October 2017
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305210
Author
Anon
Title
Quality Documentation Part 2E Finished Product Tests
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305333
Author
Anon
Title
Raw Data
Study date
2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305256
Author
L. Llames
Title
Report TH180077
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305302
Author
A. Gomez
Title
Report BM-12/10-SN
Study date
May 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305193
Author
Virbac
Title
Efficacy and Safety Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305293
Author
I. Hallett
Title
Report 0538/051-D6146
Study date
July 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305247
Author
A. Rusca
Title
Report CRO-PK-01-48
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305250
Author
L. Martinez
Title
Report BM-01/20
Study date
December 2004
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305227
Author
M. Colombo
Title
Report AI-99/03-SN
Study date
June 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305313
Author
P. Sarasola
Title
Report ONDAX (DA/184/C and DA/197/C)
Study date
July 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305270
Author
L. Martinez
Title
Report BM-99/30-SN
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305276
Author
J. Zapatero
Title
Report CD-98/6358T
Study date
December 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305319
Author
Chemwatch
Title
Safety Data Sheet
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305190
Author
Virbac
Title
Application Summary
Study date
April 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305213
Author
Anon
Title
Quality Documentation Part 2F2 Stability Finished Product
Study date
November 2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305330
Author
KuKanich, B
Title
Geriatric Veterinary Pharmacology
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
305236
Author
J. Sola
Title
Report 112318
Study date
October 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305259
Author
M. Serafini
Title
Report BM-00/11
Study date
October 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305196
Author
Virbac
Title
Health Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305207
Author
Anon
Title
Quality Documentation Part 2C4 Starting Materials
Study date
December 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305253
Author
L. Martinez
Title
Report BM-99/16
Study date
April 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305290
Author
A. Arano
Title
Report CD-98/6396FD
Study date
February 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305299
Author
Innes et al
Title
Use of non-steroidal anti-inflammatory drugs for the treatment of canine osteoarthritis
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
305296
Author
M. Salichs
Title
Report 123019
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305273
Author
I. Demestre
Title
Report T-98/06
Study date
January 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305204
Author
Anon
Title
Appendix 2C.1-1 Active Substance Master File
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305267
Author
L. Martinez
Title
Report BM-00/09
Study date
March 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305279
Author
J. Zapatero
Title
Report CD-98/6360T
Study date
January 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305230
Author
O. Szkuta
Title
Report A113483
Study date
October 2012
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305316
Author
Edamura et al
Title
Comparison of oral robenacoxib and carprofen for the treatment of osteoarthritis in dogs: a randomised clinical trial
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
305322
Author
European Medicines Agency
Title
Summary of Product Characteristics
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
305285
Author
A. Guzman
Title
Report T-98/07
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305262
Author
L. Gombau
Title
Report AT18P2501-01
Study date
January 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305191
Author
Virbac
Title
Chemistry and Manufacture Summary Product
Study date
April 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305331
Author
Homedes, J et al
Title
A blinded, randomized and controlled multicenter field study investigating the safety and efficacy of long-term use of enflicoxib in the treatment of naturally occurring osteoarthritis in client-owned dogs
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
305308
Author
S. Puig
Title
Report BM-14/20
Study date
October 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305208
Author
Anon
Title
Quality Documentation Part 2D Control Tests
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305291
Author
A. Arano
Title
Report CD-98/6398FD
Study date
February 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305254
Author
R. Farran
Title
Report BM-10/24-SN
Study date
October 2011
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305199
Author
Anon
Title
Certificate of GMP
Study date
February 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305245
Author
L. Martinez
Title
Report BM-00/17
Study date
September 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305225
Author
M. Colombo
Title
Report AI-99/13-SN
Study date
May 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305274
Author
I. Demestre
Title
Report T-99/05
Study date
March 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305205
Author
Anon
Title
Active Substance Master File
Study date
January 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305219
Author
J. Buxens
Title
Report SNEC-13/11-SN
Study date
May 2014
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305231
Author
O. Szkuta
Title
Report A123936
Study date
December 2012
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305268
Author
L. Martinez
Title
Report BM-99/15
Study date
November 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305325
Author
Brown, D. C et al
Title
Development and psychometric testing of an instrument designed to measure chronic pain in dogs with osteoarthritis
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
305317
Author
Lees et al
Title
Pharmacokinetics, pharmacodynamics, toxicology and therapeutics of mavacoxib in the dog: a review
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
305211
Author
Anon
Title
Certificate of GMP
Study date
November 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305282
Author
J. Zapatero
Title
Report CD-99/6640T
Study date
December 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305288
Author
A. Arano
Title
Report CD-98/6393FD
Study date
March 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305305
Author
J. Cendros
Title
Report EV-013/09-SN
Study date
December 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305311
Author
J. Cendros
Title
Report PK_001_2019
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305234
Author
M. Serafini
Title
Report BM-01/18-SN
Study date
March 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305242
Author
L. Martinez
Title
Report BM-99-06-SN
Study date
October 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305294
Author
M. Salichs
Title
Report 123119
Study date
December 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305248
Author
L. Martinez
Title
Report BM-01/24
Study date
August 2004
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305202
Author
C.J.R. van Barneveld
Title
Appendic 2B.3-1
Study date
June 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305251
Author
L. Salgado et al
Title
Chirality, 16: 302-308
Study date
2004
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305228
Author
M. Colombo
Title
Report AI-99/07-SN
Study date
March 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305328
Author
Lascelles, B.D.X et al
Title
Guidelines for Safe and Effective Use of NSAIDs in Dogs
Study date
2005
Authorising party
Public
Auth party contact address
-
Data no
305265
Author
A. Arano
Title
Report CD-98/6361FD
Study date
December 1998
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305314
Author
H. Noguer
Title
Report EV-19/01-SN
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305222
Author
M. Colombo
Title
Report AI 99/06-SN
Study date
May 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305271
Author
I. Demestre
Title
Report T-98/05
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305214
Author
Anon
Title
Quality Documentation Part 2C3 Packaging
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305237
Author
J. Sola
Title
Report 112218
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305306
Author
J. Cendros
Title
Report PK_001_2018
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305312
Author
J. Cendros
Title
Report PK_001_2020
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305329
Author
KuKanich, B et al
Title
Clinical pharmacology of nonsteroidal anti-inflammatory drugs in dogs
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
305260
Author
J. Sola
Title
Report 118419
Study date
November 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305283
Author
J. Zapatero
Title
Report CD-98/6369T
Study date
May 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305243
Author
L. Martinez
Title
Report BM-99/03
Study date
July 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305289
Author
A. Arano
Title
Report CD-98/6397FD
Study date
March 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305300
Author
Toutin et al
Title
A pharmacokinetic / pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog
Study date
2001
Authorising party
Public
Auth party contact address
-
Data no
305197
Author
Virbac
Title
Environment Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305297
Author
M. Salichs
Title
Report 136720
Study date
July 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305203
Author
Anon
Title
Quality Documentation Part 2C1 Active
Study date
February 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305229
Author
M. Colombo
Title
Report FI-00/01-SN
Study date
January 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305280
Author
H. Williams
Title
Report VX05LK
Study date
September 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305266
Author
L. Martinez
Title
Report BM-00/16
Study date
March 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305217
Author
M. Colombo
Title
Report AI-99/01-SN
Study date
October 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305223
Author
I. Alvarez
Title
Report AI-99/12-SN
Study date
September 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305323
Author
Virbac
Title
Cover Letter
Study date
6 February 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305309
Author
P. Sarasola
Title
Report DA/197/C
Study date
December 2018
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305286
Author
I. Demestre
Title
Report T-98/08
Study date
April 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305263
Author
J. Sola
Title
Report 113518
Study date
November 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305240
Author
L. Martinez
Title
Report BM-98/21
Study date
June 2001
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305257
Author
A. Barlagne
Title
Report A186725
Study date
May 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305332
Author
Anon
Title
Raw Data
Study date
2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305303
Author
S. Puig
Title
Report BM-10/28
Study date
October 2016
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305194
Author
Virbac
Title
Safety Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305200
Author
Anon
Title
Quality Documentation Part 2A Qualitative Particulars
Study date
February 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305246
Author
L. Martinez
Title
Report BM-00/02
Study date
April 2002
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305226
Author
M. Colombo
Title
Report AI-99/04-SN
Study date
January 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305249
Author
L. Martinez
Title
Report BM-01/31-SN
Study date
April 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305206
Author
Anon
Title
Quality Documentation Part 2C2 Starting Materials
Study date
February 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305220
Author
D. Romenov
Title
Report 284110
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305277
Author
A.Guzman
Title
Report T-00/08
Study date
March 2003
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305326
Author
Brown, D. C et al
Title
Power of treatment success definitions when the Canine Brief Pain Inventory is used to evaluate carprofen treatment for the control of pain and inflammation in dogs with osteoarthritis
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
305269
Author
A. Arano
Title
Report CD-98/6399FD
Study date
February 1999
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
305320
Author
VICH
Title
ENVIRONMENTAL IMPACT ASSESSMENT (EIAS) FOR VETERINARY MEDICINAL PRODUCTS (VMPS) - PHASE I
Study date
June 2000
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

154875
Product/Active constituent Name

Application Product Name

FARMALINX THUNDERCAT 700 WG HERBICIDE

Application details

Product name:

FARMALINX THUNDERCAT 700 WG HERBICIDE

Product number:

67752

Applicant Name:

FARMALINX PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add the use on turf and add a manufacturing site

Active constituents:

Active constituent name
56083 - IMAZETHAPYR

Description of data provided:

Data no
310937
Author
Not identified
Title
Raw Material information
Study date
11 August 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310940
Author
Farmalinx Pty Ltd
Title
Proposed Draft label
Study date
11 August 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310934
Author
McCarthy J
Title
Evaluation herbicide products for control of sedges in bermuda grass situations
Study date
29 July 2024
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310935
Author
McCarthy J
Title
Evaluation herbicide products for control of sedges in bermuda grass situations
Study date
28 August 2024
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310938
Author
Farmalinx Pty Ltd
Title
Proposed label
Study date
11 August 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310932
Author
McCarthy J
Title
Evaluation herbicide products for control of Kikuyu in bermuda grass situations
Study date
25 July 2024
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310933
Author
McCarthy J
Title
Evaluation herbicide products for control of Kikuyu in bermuda grass situations
Study date
24 February 2024
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310930
Author
Farmalinx Pty Ltd
Title
Part 8 Efficacy and Crop Safety Overview
Study date
11 August 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310936
Author
Farmalinx Pty Ltd
Title
Health Dossier - Thundercat 700 WG Herbicide
Study date
August 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310931
Author
McCarthy J
Title
Evaluation herbicide products for control of Kikuyu in bermuda grass situations,
Study date
13 August 2024
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Data no
310939
Author
Farmalinx Pty Ltd
Title
Environment Dossier
Study date
11 August 2026
Authorising party
Applicant
Auth party contact address
Level 25 Suite 2506, Tower 2 101 Grafton Street BONDI JUNCTION Australia
Date

Application Date

Application No

Application Number

154419
Product/Active constituent Name

Application Product Name

DIATHOR BED BUG KILLER AEROSOL

Application details

Product name:

DIATHOR BED BUG KILLER AEROSOL

Product number:

70222

Applicant Name:

ENSYSTEX AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add a use to control cockroaches and change the product name.

Reference details:

94541 - Diathor Flowable Long-Term Insect Killer

Active constituents:

Active constituent name
60266 - AMORPHOUS SILICA

Description of data provided:

Data no
310847
Author
S Broadbent
Title
Cockroach efficacy trials ??? Diathor Flowable Long-Term Insect Killer
Study date
09/11/2023
Data no
310846
Author
Ensystex Australasia Pty Ltd
Title
Diathor Flowable Long-term Insect Killer (94541/142728)
Study date
11/2/2025
Authorising party
Applicant
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
310844
Author
S Broadbent
Title
Cockroach efficacy trials ??? Diathor Bed Bug Killer Aerosol
Study date
22/06/2026
Authorising party
Applicant
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
310845
Author
APVMA
Title
Agricultural chemicals efficacy and safety technical report
Study date
11/09/2024
Authorising party
Applicant
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Data no
310848
Author
F Johnston
Title
Part 8 Summary
Study date
July 2026
Authorising party
Applicant
Auth party contact address
Warehouse D Building 6 The Switchyard 161 Manchester Road AUBURN Australia
Date

Application Date

Application No

Application Number

154868
Product/Active constituent Name

Application Product Name

IMTRADE MOTTO RMR MITICIDE

Application details

Product name:

IMTRADE MOTTO RMR MITICIDE

Product number:

92373

Applicant Name:

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend uses for aerial application by fixed-wing aircraft in Cotton as specified in the Directions for Use table.

Active constituents:

Active constituent name
89349 - Etoxazole
Active constituent name
65954 - PIPERONYL BUTOXIDE

Description of data provided:

Data no
310926
Author
N/A
Title
Ciomments to Support Efficacy and Host Crop Safety Data submitted.
Study date
10/08/2026
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
310927
Author
N/A
Title
Imtrade MOTTO?? RMR?? Miticide - Draft RLP_V1 Marked Copy 11082026
Study date
11/08/2026
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
310924
Author
N/A
Title
Investigate the Efficacy of IMTRADE MIKADO?? 750 VeripHy?? EC MITICIDE for the control of Mites in Cotton as an aerial application. - One Trial, Coleambally, NSW
Study date
June 2026
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
310925
Author
N/A
Title
Investigate the Efficacy of IMTRADE MOTTO?? RMR?? MITICIDE for the control of Mites in Cotton as an aerial application. - One Trial, Coleambally, NSW
Study date
June 2026
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date

Application Date

Application No

Application Number

155148
Product/Active constituent Name

Application Product Name

imepitoin

Application details

Product name:

imepitoin

Active name:

imepitoin

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Approval of imepitoin for use in veterinary chemical products.

Description of data provided:

Data no
310737
Author
Boehringer Ingelheim
Title
12. Quality documentation - API
Study date
01/10/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310725
Author
Boehringer Ingelheim
Title
4. Control of critical steps and intermediates
Study date
30/01/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310731
Author
Boehringer Ingelheim
Title
10. batch analyses - imepitoin
Study date
27/03/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310728
Author
Boehringer Ingelheim
Title
7. Impurities in the drug substance
Study date
09/04/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310734
Author
withheld
Title
11.3 analytical method - particle size
Study date
12/05/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310723
Author
Boehringer Ingelheim
Title
2. specifications imepitoin
Study date
07/05/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310729
Author
withheld
Title
8. batch analyses - imepitoin
Study date
10/02/2019
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310726
Author
Boehringer Ingelheim
Title
5. manufacturing process development
Study date
05/06/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310732
Author
withheld
Title
11.1 analytical method - related substances and assay
Study date
16/05/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310727
Author
Boehringer Ingelheim
Title
6. Control of materials
Study date
22/06/2026
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310735
Author
withheld
Title
11.4 analytical method
Study date
16/05/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310738
Author
Boehringer Ingelheim
Title
13. Executive summary - imepitoin
Study date
20/08/2026
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310724
Author
Boehringer Ingelheim
Title
3. Description of manufacturing prcess and process controls
Study date
25/03/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310733
Author
withheld
Title
11.2 analytical method validation
Study date
16/05/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310722
Author
Boehringer Ingelheim
Title
1. GMP status of the manufacturer
Study date
30/08/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310736
Author
withheld
Title
11.5 analytical method validation - residual solvens
Study date
16/05/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
310730
Author
Boehringer Ingelheim
Title
9. imepitoin - master specifications
Study date
07/05/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

154423
Product/Active constituent Name

Application Product Name

MACSPRED VELMAC G GRANULAR HERBICIDE

Application details

Product name:

MACSPRED VELMAC G GRANULAR HERBICIDE

Product number:

45442

Applicant Name:

MACSPRED PTY. LTD.

Application purpose and description of use:

Variation of product registration to seek approval for minor formulation change and to revise the current manufacturing process.

Active constituents:

Active constituent name
44321 - HEXAZINONE
Active constituent name
48098 - HEXAZINONE

Description of data provided:

Data no
310869
Author
Nayyar, P.
Title
Part 2 - Chemistry and Manufacture
Study date
09 July 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

154769
Product/Active constituent Name

Application Product Name

ASTRALPOOL MINERAL GUARD

Application details

Product name:

ASTRALPOOL MINERAL GUARD

Product number:

93454

Applicant Name:

FLUIDRA GROUP AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of label approval to rectify the net contents supplied for the product and update associated 'Direction for Use'.

Active constituents:

Active constituent name
55410 - COPPER
Active constituent name
52230 - SILVER METAL

Description of data provided:

Data no
311227
Author
N/A
Title
Mineral Guard Label
Study date
2026
Authorising party
Applicant
Auth party contact address
1 Herbert Place SMITHFIELD Australia
Date

Application Date

Application No

Application Number

154782
Product/Active constituent Name

Application Product Name

Titan Titanium Herbicide

Application details

Product name:

Titan Titanium Herbicide

Product number:

92218

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add applications to malting barley to the directions for use

Active constituents:

Active constituent name
62532 - GLYPHOSATE
Date

Application Date

Application No

Application Number

154783
Product/Active constituent Name

Application Product Name

Mortein Freeze & Kill Cockroach & Ant Killer

Application details

Product name:

Mortein Freeze & Kill Cockroach & Ant Killer

Product number:

94706

Applicant Name:

AU PEST PTY LIMITED

Application purpose and description of use:

Variation of product registration and label approval to add a fragrance to the formulation and make several label changes, including to product name, statement of claims and a minor change to usage instructions.

Reference details:

94706 - Mortein Freeze & Kill Cockroach & Ant Killer
Date

Application Date

Application No

Application Number

154832
Product/Active constituent Name

Application Product Name

Macspred Trimac GR Granular Herbicide

Application details

Product name:

Macspred Trimac GR Granular Herbicide

Product number:

81670

Applicant Name:

MACSPRED PTY. LTD.

Application purpose and description of use:

Variation of product registration to seek approval for minor formulation change.

Active constituents:

Active constituent name
64443 - TERBACIL
Active constituent name
47043 - SULFOMETURON-METHYL
Date

Application Date

Application No

Application Number

153286
Product/Active constituent Name

Application Product Name

TERMINADE RESIDUAL TERMITICIDE AND INSECTICIDE

Application details

Product name:

TERMINADE RESIDUAL TERMITICIDE AND INSECTICIDE

Product number:

63502

Applicant Name:

PCT HOLDINGS PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to modify the Directions for Use,

Reference details:

80820 - Termidor HE Residual Termiticide

Active constituents:

Active constituent name
58418 - FIPRONIL

Description of data provided:

Data no
310227
Author
BASF Australia Ltd
Title
Termidor HE Residual Termiticide 80820/108128
Study date
31/05/2017
Authorising party
Public
Auth party contact address
-
Data no
310224
Author
S Kleinschmidt
Title
A field efficacy evaluation to determine if the existing hole spacings for Terminade can be increased when rodding through concrete
Study date
April 2026
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
310225
Author
M Keats
Title
Certificate of Analysis
Study date
09/04/2026
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
310228
Author
R Murray
Title
Part 8 Summary
Study date
May 2026
Authorising party
Applicant
Auth party contact address
51 Prosperity Place PARK RIDGE Australia
Data no
310226
Author
BASF Australia Ltd
Title
Termidor HE Residual Termiticide 80820/146381
Study date
25/02/2025
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

153643
Product/Active constituent Name

Application Product Name

RAID MAX ANT KILLER SURFACE SPRAY

Application details

Product name:

RAID MAX ANT KILLER SURFACE SPRAY

Product number:

68423

Applicant Name:

S.C. JOHNSON & SON PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend residual claims and extend pack sizes to a range. Update to the Labelling Code.

Reference details:

68421 - Raid MAX Outdoor Home Barrier & Spider Killer Surface Spray

Active constituents:

Active constituent name
55628 - DELTAMETHRIN
Active constituent name
50876 - IMIPROTHRIN MANUFACTURING CONCENTRATE

Description of data provided:

Data no
310300
Author
P F Miller
Title
Laboratory Study to Determine the Residual Efficacy of Raid MAX Outdoor Surface Spray and Raid MAX Ant Killer Surface Spray Against a Range of Arthropod Pests - 12 Month Outdoor Study
Study date
16/04/2026
Authorising party
Applicant
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
310301
Author
F Johnston
Title
Part 8 Summary 68423
Study date
June 2026
Authorising party
Applicant
Auth party contact address
160 EPPING RD LANE COVE Australia
Date

Application Date

Application No

Application Number

153645
Product/Active constituent Name

Application Product Name

SPRAYS 2 WAYS RAID MAX ANTIBACTERIAL FAST KILL CRAWLING INSECT KILLER

Application details

Product name:

SPRAYS 2 WAYS RAID MAX ANTIBACTERIAL FAST KILL CRAWLING INSECT KILLER

Product number:

65861

Applicant Name:

S.C. JOHNSON & SON PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend residual claims and update to the Labelling Code.

Active constituents:

Active constituent name
51810 - CYPERMETHRIN
Active constituent name
50876 - IMIPROTHRIN MANUFACTURING CONCENTRATE

Description of data provided:

Data no
310302
Author
P F Miller
Title
Laboratory Study to Determine the Residual Efficacy of Raid MAX Antibacterial Fast Kill Crawling Insect Killer Against a Range of Arthropod Pests - 12 Month Indoor Study
Study date
18/04/2026
Authorising party
Applicant
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
310303
Author
F Johnston
Title
Part 8 Summary 65861
Study date
June 2026
Authorising party
Applicant
Auth party contact address
160 EPPING RD LANE COVE Australia