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

145693
Product/Active constituent Name

Application Product Name

Randlab Vitamin B1 Injection

Application details

Product name:

Randlab Vitamin B1 Injection

Product number:

95439

Applicant Name:

RANDLAB AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a Randlab vitamin B1 injection containing 125mg/mL thiamine hydrochloride as supplement for horses and dogs.

Reference details:

49860 - NV VITAMIN B1 INJECTION

Active constituents:

Active constituent name
57667 - VITAMIN B1

Description of data provided:

Data no
278740
Author
Anon
Title
Finished Product Specification
Study date
03 Oct 2024
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Date

Application Date

Application No

Application Number

145309
Product/Active constituent Name

Application Product Name

Daxocox 15mg tablets for dogs

Application details

Product name:

Daxocox 15mg tablets for dogs

Product number:

95332

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 15mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.

Active constituents:

Active constituent name
95331 - Enflicoxib (INN)

Description of data provided:

Data no
277501
Author
N. Booden et al
Title
Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277485
Author
Virbac
Title
Chemistry and Manufacture Summary Product
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277491
Author
Anon
Title
Certificate of GMP
Study date
Dec 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277492
Author
Anon
Title
Certificate of GMP
Study date
June 2022
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277493
Author
Anon
Title
Quality Documentation Part 2A Qualitative Particulars
Study date
January 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277494
Author
Anon
Title
Quality Documentation Part 2B Manufacture
Study date
December 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277496
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
277497
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
277500
Author
Anon
Title
Quality Documentation Part 2E Finished Product Tests
Study date
November 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
278365
Author
Anon
Title
GMP Certificate 2023
Study date
2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277498
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
277499
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
277495
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
277503
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
277504
Author
Anon
Title
Certificates of Analysis
Study date
January 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277505
Author
L. Saavedra
Title
Detailed and Critical Summary on the Pharmaceutical Documentation
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277502
Author
Anon
Title
Quality Documentation Part 2F2 Stability Finished Product
Study date
October 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277486
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
277488
Author
Virbac
Title
Efficacy Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277604
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
277605
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
277606
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
277587
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
277588
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
277589
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
277590
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
277591
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
277592
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
277593
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
277594
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
277595
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
277596
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
277597
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
277598
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
277599
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
277600
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
277601
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
277602
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
277603
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
277570
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
277571
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
277572
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
277573
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
277574
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
277575
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
277576
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
277578
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
277579
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
277580
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
277581
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
277582
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
277583
Author
M. Salichs
Title
Report 123119
Study date
December 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277584
Author
M. Salichs
Title
Report 123219
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277585
Author
M. Salichs
Title
Report 123019
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277586
Author
M. Salichs
Title
Report 136720
Study date
July 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277607
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
277535
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
277528
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
277530
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
277532
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
277537
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
277538
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
277539
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
277540
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
277546
Author
A. Barlagne
Title
Report A186725
Study date
May 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277547
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
277556
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
277557
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
277558
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
277559
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
277560
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
277561
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
277562
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
277563
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
277564
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
277565
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
277566
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
277567
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
277568
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
277548
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
277549
Author
J. Sola
Title
Report 118419
Study date
November 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277550
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
277551
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
277552
Author
J. Sola
Title
Report 113518
Study date
November 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277553
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
277554
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
277555
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
277541
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
277542
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
277543
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
277544
Author
O. Peris
Title
Report S27766
Study date
July 2010
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277545
Author
L. Llames
Title
Report TH180077
Study date
January 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277533
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
277534
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
277531
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
277529
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
277506
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
277507
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
277508
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
277509
Author
D. Romenov
Title
Report 284110
Study date
February 2000
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277510
Author
P. Mendoza
Title
Report S40772
Study date
October 2013
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277511
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
277512
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
277513
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
277514
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
277515
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
277516
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
277517
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
277518
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
277519
Author
O. Szkuta
Title
Report A113483
Study date
October 2012
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277520
Author
O. Szkuta
Title
Report A123936
Study date
December 2012
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277521
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
277522
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
277523
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
277524
Author
J. Sola
Title
Report 111018
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277525
Author
J. Sola
Title
Report 112318
Study date
October 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277526
Author
J. Sola
Title
Report 112218
Study date
July 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277527
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
277536
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
277577
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
277487
Author
Virbac
Title
Safety Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277569
Author
H. Williams
Title
Report VX05LK
Study date
September 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277490
Author
Virbac
Title
Environment Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277609
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
277483
Author
Virbac
Title
Cover Letter
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277484
Author
Virbac
Title
Application Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277611
Author
European Medicines Agency
Title
Summary of Product Characteristics
Study date
February 2021
Authorising party
Public
Auth party contact address
-
Data no
277610
Author
European Medicines Agency
Title
Summary of Opinion
Study date
February 2021
Authorising party
Public
Auth party contact address
-
Data no
277608
Author
Chemwatch
Title
Safety Data Sheet
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277489
Author
Virbac
Title
Health Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date

Application Date

Application No

Application Number

145313
Product/Active constituent Name

Application Product Name

Daxocox 45mg tablets for dogs

Application details

Product name:

Daxocox 45mg tablets for dogs

Product number:

95334

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 45mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.

Active constituents:

Active constituent name
95331 - Enflicoxib (INN)
Date

Application Date

Application No

Application Number

145320
Product/Active constituent Name

Application Product Name

Daxocox 70mg tablets for dogs

Application details

Product name:

Daxocox 70mg tablets for dogs

Product number:

95340

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 70mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.

Active constituents:

Active constituent name
95331 - Enflicoxib (INN)
Date

Application Date

Application No

Application Number

145321
Product/Active constituent Name

Application Product Name

Daxocox 100mg tablets for dogs

Application details

Product name:

Daxocox 100mg tablets for dogs

Product number:

95341

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 100mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.

Active constituents:

Active constituent name
95331 - Enflicoxib (INN)
Date

Application Date

Application No

Application Number

145547
Product/Active constituent Name

Application Product Name

Foison Clopyralid 750SG Herbicide

Application details

Product name:

Foison Clopyralid 750SG Herbicide

Product number:

86395

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Variation of product registration to change the net contents from 2kg to 1kg-1000kg.

Active constituents:

Active constituent name
53536 - CLOPYRALID
Date

Application Date

Application No

Application Number

145548
Product/Active constituent Name

Application Product Name

Foison Clopyralid 300 SL Herbicide

Application details

Product name:

Foison Clopyralid 300 SL Herbicide

Product number:

89077

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Variation of product registration to change the net content from 5L, 20L to 1L-1000L.

Active constituents:

Active constituent name
53536 - CLOPYRALID
Date

Application Date

Application No

Application Number

145450
Product/Active constituent Name

Application Product Name

Radial Opti Fungicide

Application details

Product name:

Radial Opti Fungicide

Product number:

92937

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of Radial Opti Fungicide product (APVMA No. 92937) label approval to amend the adjuvant statement on the label.

Active constituents:

Active constituent name
70434 - AZOXYSTROBIN
Active constituent name
82937 - Epoxiconazole

Description of data provided:

Data no
279126
Author
Rita Kulkarni
Title
Justification of Adjuvant amendment statement
Study date
21 Sep 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
279127
Author
Rita Kulkarni
Title
Proposed highlighted draft label- Radial Opti Fungicide
Study date
28 Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
279128
Author
Rita Kulkarni
Title
Proposed unhighlighted draft label- Radial Opti Fungicide
Study date
28 Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date

Application Date

Application No

Application Number

145546
Product/Active constituent Name

Application Product Name

Foison Triclopyr 600EC Herbicide

Application details

Product name:

Foison Triclopyr 600EC Herbicide

Product number:

86392

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Variation of product registration to change the net contents from 10L, 20L, 110L, 1000L to 1L-1000L.

Active constituents:

Active constituent name
53667 - TRICLOPYR BUTOXYETHYL ESTER
Date

Application Date

Application No

Application Number

145448
Product/Active constituent Name

Application Product Name

DIAFENTHIURON

Application details

Product name:

DIAFENTHIURON

Active name:

DIAFENTHIURON

Applicant Name:

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of Diafenthiuron for use in agricultural chemical products.

Description of data provided:

Data no
279120
Author
ANON
Title
Analysis Method - Diafenthiuron
Study date
2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279122
Author
ANON
Title
Five Batch Analysis of Diafenthiuron TC - Study No. R-23-533 (1~5)
Study date
08/01/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279119
Author
ANON
Title
Method of Manufacture - Diafenthiuron Tech
Study date
04/09/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279121
Author
ANON
Title
Declaration of Composition (DoC) - Diafenthiuron
Study date
30/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279123
Author
ANON
Title
Certificate of Analysis (CoA) - Diafenthiuron Tech Commercial Batches
Study date
Feb 2023
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279124
Author
ANON
Title
MSDS for Diafenthiuron 97% TC
Study date
March 2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279118
Author
N/A
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
19/09/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
279125
Author
ANON
Title
Letter of Support / Authorisation from Source - Diafenthiuron Technical
Study date
30/08/2024
Authorising party
Applicant
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date

Application Date

Application No

Application Number

145451
Product/Active constituent Name

Application Product Name

Conquest Magnitude 100 EC Selective Herbicide

Application details

Product name:

Conquest Magnitude 100 EC Selective Herbicide

Product number:

92377

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

To vary the scheduled solvent concentrations in the current formulation

Active constituents:

Active constituent name
91686 - Pyrasulfotole
Active constituent name
59970 - MEFENPYR-DIETHYL

Description of data provided:

Data no
279134
Author
Anon
Title
Appendix 2.4 ??? Active constituents??? certificate of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279132
Author
Anon
Title
Appendix 2.2 - Analysis Method and Validation Data
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279130
Author
Flora Bavand
Title
Part 2 - Chemistry and Manufacture
Study date
September 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279133
Author
Anon
Title
Appendix 2.3 - Safety Data Sheets
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279131
Author
Anon
Title
Appendix 2.1- Stability and Batch Analysis Data
Study date
August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279135
Author
Flora Bavand
Title
Part 8 - Efficacy and crop safety
Study date
September 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279136
Author
Anon
Title
Appendix 8.1 - Magnitude efficacy and safety in wheat
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279138
Author
Anon
Title
Appendix 8.3 - Magnitude efficacy and safety in barley
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279139
Author
Anon
Title
Appendix 8.4 - Magnitude efficacy and safety in barley
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279137
Author
Anon
Title
Appendix 8.2 - Magnitude efficacy and safety in wheat
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
279129
Author
Flora Bavand
Title
Conquest Magnitude 100 EC
Study date
September 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

142476
Product/Active constituent Name

Application Product Name

1,4-dimethylnaphthalene

Application details

Product name:

1,4-dimethylnaphthalene

Product number:

94459

Applicant Name:

1,4 GROUP, INC.

Application purpose and description of use:

Registration of a 980 g/L liquid formulation of 1,4-dimethylnapthalene to enhance dormancy of potatoes in storage as per the Directions For Use Table (product 94460-142477

Description of data provided:

Data no
265007
Author
D. Foster-Clark, R.L. Van Hoven
Title
Description and Validation of an Enforcement Analytical Method for the Determination of the Active Ingredient and Significant Impurities in the Technical Grade 1,4- dimethylnapthaleneetermination and Characterisation of 1,4-dimethylnapthalene (2020)
Study date
26 August 2020
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265006
Author
D. Foster-Clark, R.L. Van Hoven
Title
Determination and Characterisation of 1,4-dimethylnapthalene in Five Production Batches (2019)
Study date
23 May 2023
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265004
Author
anon
Title
Manufacturing process
Study date
2022
Authorising party
Sinonchem Hebei Fuheng Co Ltd
Auth party contact address
No 12 Fuqiang Road, Economic Development Zone of CI County, Handan City, Hebei 056500 China
Data no
265005
Author
A. Vachon
Title
Declaration of Composition
Study date
December 2023
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
286060
Author
anon
Title
Process Flow Chart & Quality Control
Study date
April 2025
Authorising party
Sinochem Hebei Fuheng Co Ltd
Auth party contact address
NO.12 FUQIANG ROAD, ECONOMIC DEVELOPMENT ZONE OF CI COUNTY, HANDAN CITY, HEBEI 056500, CHINA
Data no
286061
Author
Anon
Title
Impurities Discussion
Study date
April 2025
Authorising party
SINOCHEM HEBEI FUHENG CO., LTD.
Auth party contact address
NO.12 FUQIANG ROAD, ECONOMIC DEVELOPMENT ZONE OF CI COUNTY, HANDAN CITY, HEBEI 056500, CHINA
Data no
265086
Author
The Netherlands
Title
Final Addendum to the Draft Assessment Report (DAR) 1,4-Dimethylnapthalene
Study date
April 2013
Authorising party
Public
Auth party contact address
-
Data no
264996
Author
J.A. Pelton
Title
1,4-DMN Batch H5510 -Clor, Physical Statment, Odor, Boiling Point, Specific Gravity, pH, Flammability, Impact Explodability, Viscosity
Study date
12 November 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264997
Author
L.D. Vargyas, J.R. Marsh, S.J. Yoder
Title
1,4-DMN Vapor Pressure
Study date
14 December 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264998
Author
P.J. Lorence, L.D. Vargyas, J.R. Marsh
Title
1,4-DMN Solubility
Study date
16 December 2023
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264999
Author
T.Z. Kendall, W.B. Nixon
Title
Determination of the Solubility of 1,4-Dimethylnapthalene in Organic Solvents by the Shake Glass Method
Study date
1 December 2005
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265000
Author
P.J.J.M Weterings
Title
Determination of explosive properties and oxidizing properties for 1,4-Dimethylnapthalene (expert statement)
Study date
18 November 2003
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265001
Author
A. Tunink
Title
1,4-DMN Determination of Surface Tension
Study date
19 February 2021
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265002
Author
P.J.J.M Weterings
Title
Calculation of Henry's Law Constant for 1,4-Dimethylnapthalene
Study date
18 November 2003
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265003
Author
-
Title
Henrys Law Calculation 14DMN and impurities
Study date
2024
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
286062
Author
J.M. Sanders
Title
1,4-DMN Stability
Study date
10 December 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264995
Author
anon
Title
Executive Summary
Study date
November 2023
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265018
Author
W.D. Johnson
Title
Acute Dermal Toxicity of 1,4-dimethylnapthalene (1,4-DMN) in Rabbits (Limit Test)
Study date
October 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265019
Author
N. Rajendran
Title
Acute Inhalation Toxicity of 1,4-dimethylnapthalene (1,4-DMN) in Rats
Study date
October 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265017
Author
S.K. Shults, A.V. Brock, J. Laveglia
Title
S.K. Shults, A.V. Brock, J. Laveglia
Study date
27 October 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265025
Author
T.E. Lawler
Title
Mutagenicity Test of 1,4-Dimethylnaphthane in the Salmonella/Mammalian-Microsome Reverse Mutation Assay (Ames Test)
Study date
21 September 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265026
Author
P. Weterings
Title
Reverse Mutation in 5ive histidine-requiring strains of Salmonella typhimurium
Study date
July 2007
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265027
Author
H. Murli
Title
Mutagenicity Test on 1,4-dimethylnapthalene in vivo mouse micronucleus assay
Study date
24 August 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265028
Author
A.L. Ham
Title
Genotoxicity Test on 1,4-dimethylnapthalene in the assay for unscheduled DNA synthesis in Rat Liver primary cell cultures
Study date
28 September 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265029
Author
P. Weterings
Title
Measurement of Unscheduled DNA synthesis in rat liver using an in vivo/in vitro procedure
Study date
November 2007
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265020
Author
W.D. Johnson
Title
Dermal Sensitization Study of 1,4-dimethylnapthalene (1,4-DMN) in Guinea Pigs using the modified Buehler Method
Study date
October 1993
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265023
Author
E. Mallett
Title
Oral (Diet Admixture) Combined Chronic Toxicity/ Carcinogenicity Study of 1,4- Dimethylnapthalene in Rats
Study date
3 March 2011
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265024
Author
B. Ryan, N. Haloum
Title
Oral Developmental Toxicity Study of 1,4-Dimethylnaphthalene in Rabbits
Study date
31 March 2011
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265016
Author
anon
Title
Part 3 Toxicology
Study date
December 2023
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265030
Author
W.J.M. Mass
Title
In vitro percutaneous absorption of 1,4-dimethlynapthalene through human skin
Study date
23 April 2009
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265021
Author
E.J. Mallett
Title
90 Day Oral Toxicity Study of 1,4-Dimethylnapthalene in Rats
Study date
25 September 2003
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265022
Author
B. Ryan, N. Haloum
Title
Extended One Generation Reproductive Toxicity Study of 1,4-DMN Administered Orally to Rats
Study date
31 March 2011
Authorising party
Applicant
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Date

Application Date

Application No

Application Number

145308
Product/Active constituent Name

Application Product Name

Enflicoxib (INN)

Application details

Product name:

Enflicoxib (INN)

Product number:

95331

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 15mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.

Description of data provided:

Data no
277614
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
277615
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
277616
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
277617
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
277618
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
Date

Application Date

Application No

Application Number

145545
Product/Active constituent Name

Application Product Name

Foison Epoxiconazole 125 SC Fungicide

Application details

Product name:

Foison Epoxiconazole 125 SC Fungicide

Product number:

86391

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Variation of product registration to change the net contents from 5L, 10L, 20L to 1L-1000L.

Active constituents:

Active constituent name
64042 - EPOXICONAZOLE
Date

Application Date

Application No

Application Number

145543
Product/Active constituent Name

Application Product Name

Foison Diquat 200SL Herbicide

Application details

Product name:

Foison Diquat 200SL Herbicide

Product number:

88796

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Variation of product registration to change the net contents from 5L-110L to 1L-1000L.

Reference details:

88796 - Foison Diquat 200SL Herbicide

Active constituents:

Active constituent name
67123 - DIQUAT DIBROMIDE
Date

Application Date

Application No

Application Number

145544
Product/Active constituent Name

Application Product Name

Foison Fluroxypyr 200EC Herbicide

Application details

Product name:

Foison Fluroxypyr 200EC Herbicide

Product number:

86388

Applicant Name:

Foison Scitech Co., Limited

Application purpose and description of use:

Variation of product registration to change the net contents from 1L, 5L, 20L to 1-1000L

Active constituents:

Active constituent name
59455 - FLUROXYPYR-MEPTYL
Date

Application Date

Application No

Application Number

145563
Product/Active constituent Name

Application Product Name

HEADWAY SELAMECTIN SPOT-ON FOR CATS

Application details

Product name:

HEADWAY SELAMECTIN SPOT-ON FOR CATS

Product number:

95417

Applicant Name:

HEADWAY INVESTMENTS PTY LTD

Application purpose and description of use:

Registration of a 60mg/mL selamectin spot on product for cats and rabbits.

Reference details:

50881 - REVOLUTION FOR CATS

Active constituents:

Active constituent name
94645 - Selamectin

Description of data provided:

Data no
279062
Author
Not Identified
Title
Justification for New Product
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
2 Kippax St GREYSTONES Australia
Data no
279060
Author
Not Identified
Title
Finished Product Specifications
Study date
Sep 2024
Authorising party
Applicant
Auth party contact address
2 Kippax St GREYSTONES Australia
Data no
279061
Author
APVMA
Title
Confirmation: Overseas Site GMP Compliance
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
2 Kippax St GREYSTONES Australia
Date

Application Date

Application No

Application Number

145357
Product/Active constituent Name

Application Product Name

Saflufenacil

Application details

Product name:

Saflufenacil

Active name:

Saflufenacil

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Approval of a new source of saflufenacil for use in agricultural products.

Description of data provided:

Data no
278673
Author
Anon
Title
Five-Batch Analysis of Saflufenacil
Study date
August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
278672
Author
Anon
Title
Manufacturing Process of Saflufenacil Technical
Study date
August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
278671
Author
Flora Bavand
Title
Part 2 - Chemistry and Manufacture
Study date
September 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
278674
Author
Anon
Title
Declaration of Composition for Saflufenacil
Study date
September 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
278675
Author
Anon
Title
Certificate of Analysis
Study date
Feb 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

145542
Product/Active constituent Name

Application Product Name

Potassium Bicarbonate

Application details

Product name:

Potassium Bicarbonate

Active name:

Potassium Bicarbonate

Applicant Name:

AGRONATURALIS LIMITED

Application purpose and description of use:

Approval of Potassium Bicarbonate for use in agricultural chemical products.

Description of data provided:

Data no
279103
Author
Anon
Title
Potassium Hydrogen Carbonate Titration Method Specification.
Study date
2012
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279104
Author
Campbell, N.
Title
KHCO3 - Titration Method (including HCl Standardisation).
Study date
2015
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279105
Author
Anon
Title
Analytical Methods for the Determination of the Active Substance Potassium Hydrogen Carbonate in the Formulated Product.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279106
Author
Olexa, S.
Title
Validation of the Analytical Method for the Quantitation of Potassium Bicarbonate Active Ingredient.
Study date
1997
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279111
Author
Anon
Title
Potassium Bicarbonate Document J#1 Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279112
Author
Anon
Title
Potassium Bicarbonate Document J#2 Sep 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279113
Author
Anon
Title
Potassium Bicarbonate Document J#2a Sep 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279114
Author
Anon
Title
Potassium Bicarbonate Document J#3 Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279115
Author
Anon
Title
Potassium Bicarbonate Document J#3a Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279083
Author
Anon
Title
Potassium Bicarbonate Specification.
Study date
2016
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279093
Author
Campbell, N..
Title
Potassium Hydrogen Carbonate - AnalysIs of 5 Batches of Technical Material for Active Ingredient and Potassium Carbonate Impurity.
Study date
2018
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279094
Author
Sowle, J.
Title
Analysis of 5 Batches of Potassium Hydrogen Carbonate Technical Material to Determine the Content of the Active Ingredient and Specified Impurities, in Compliance with Good Laboratory Practice.
Study date
2017
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279095
Author
Sowle, J.
Title
Validation of the Method of Determination of the Active Ingredient and Specified Impurities in Potassium Hydrogen Carbonate Technical Materia, in Compliance with Good Laboratory Practice.
Study date
2017
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279096
Author
Cheng, K. M.
Title
Analyses of Five Batches of Potassium Hydrogen Carbonate (Food Grade) Technical Material to Include the Determination of Relevant Impurities ??? Part 1.
Study date
2013
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279099
Author
Cheng, K. M.
Title
Analyses of Five Batches of Potassium Hydrogen Carbonate (Food Grade) Technical Material to Include the Determination of Relevant Impurities ??? Part 4.
Study date
2013
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279100
Author
Gandhi, J. S. G.
Title
Analyses of Five Batches of Potassium Hydrogen Carbonate (Food Grade) Technical Material to Include the Determination of Relevant Impurities.
Study date
2018
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279101
Author
Hair, L.
Title
Potassium Hydrogen Carbonate ??? 5 Batch Analysis.
Study date
2022
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279102
Author
Hair, L.
Title
Potassium Hydrogen Carbonate - Validation of the Analytical Method Used to Analyse Impurities Arsenic and Lead.
Study date
2022
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279097
Author
Cheng, K. M.
Title
Analyses of Five Batches of Potassium Hydrogen Carbonate (Food Grade) Technical Material to Include the Determination of Relevant Impurities ??? Part 2.
Study date
2013
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279098
Author
Cheng, K. M.
Title
Analyses of Five Batches of Potassium Hydrogen Carbonate (Food Grade) Technical Material to Include the Determination of Relevant Impurities ??? Part 3.
Study date
2013
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279084
Author
Anon
Title
Product Chemistry: Armicarb Potassium Bicarbonate, F.C.C.
Study date
1994
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279085
Author
Anon
Title
Conclusion on the Peer Review of the Pesticide Risk Assessment of the Active Substance Potassium Hydrogen Carbonate. Appendix A ??? List of End Points for the Active Substance and the Representative Formulation.
Study date
2021
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279086
Author
Anon
Title
Bicarbonate, Salts of (Potassium) Volume 4 Annex C to the Draft Report and Proposed Decision - First Inclusion.
Study date
2006
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279087
Author
Anon
Title
Bicarbonate, Salts of (Potassium) Volume 4 Annex C to the Draft Report and Proposed Decision - Revised Inclusion.
Study date
2011
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279088
Author
Anon
Title
Bicarbonate, Salts of (Potassium) Volume 4 Annex C to the Draft Report and Proposed Decision - Revised Inclusion - Addendum.
Study date
2011
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279089
Author
Anon
Title
Potassium Hydrogen Carbonate - Volume 4 - Confidential Information - Agronaturalis Ltd.
Study date
2021
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279090
Author
Walker, F.
Title
Potassium Hydrogen Carbonate Equivalence of Technical Material According to Article 38 of Regulation (EU) No 1107/2009.
Study date
2014
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279091
Author
Anon
Title
Evaluation Report on the Equivalence of Technical Material for the Active Substance Potassium Hydrogen Carbonate.
Study date
2019
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279092
Author
Anon
Title
Evaluation Report on the Equivalence of Technical Material for the Active Substance Potassium Hydrogen Carbonate.
Study date
2022
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279081
Author
Anon
Title
Potassium Hydrogen Carbonate Specification.
Study date
2017
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279082
Author
Anon
Title
Potassium Bicarbonate USP Monograph.
Study date
2019
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279107
Author
Anon
Title
Potassium Bicarbonate Document J#4 Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279108
Author
Anon
Title
Potassium Bicarbonate Document J#5 Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279109
Author
Anon
Title
Potassium Bicarbonate Document J#6 Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279110
Author
Anon
Title
Potassium Bicarbonate Document J#7 Jul 24.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279116
Author
Anon
Title
Potassium Bicarbonate New Source Part 2 Chemistry August 2024.
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Data no
279080
Author
Anon
Title
Potassium Bicarbonate New Source Part 2 Chemistry August 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
Suite 2 Crown House 2 Southampton Road Ringwood United Kingdom
Date

Application Date

Application No

Application Number

145440
Product/Active constituent Name

Application Product Name

FireHawk Bioherbicide Super Concentrate

Application details

Product name:

FireHawk Bioherbicide Super Concentrate

Product number:

95387

Applicant Name:

CONTACT BIOSOLUTIONS PTY LTD

Application purpose and description of use:

Registration of a 777g/L nonanoic acid emulsifiable concentrate non-selective herbicide for the control of weeds in public areas including parks, curbs, verges, playgrounds, gardens, schools, sporting grounds, nurseries, bushland, fence lines, and other situations as per the Directions for Use.

Description of data provided:

Data no
278721
Author
OQ Chemicals Corporation
Title
Appendix 2 OQ Chemicals Nonanoic Acid/ / Pelargonic Acid Certificate of Analysis Batch P0621430AP
Study date
24 May 2021
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278722
Author
APVMA
Title
Appendix 3 Exempt Status of Nonanoic Acid
Study date
26 November 2020
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278720
Author
OQ Chemicals Corporation
Title
Appendix 1 Sales Specification Pelargonic acid
Study date
15 May 2020
Authorising party
Public
Auth party contact address
-
Data no
278724
Author
Roger Franklin
Title
Appendix 5 Determination of Nonanoic Acid in EC Formulations ( 700 - 800 gL Nonanoic acid)
Study date
16 July 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278718
Author
Roger Franklin
Title
FireHawk Bioherbicide Super Concentrate PART 2 Chemistry and Manufacture
Study date
15 July 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278719
Author
Roger Franklin
Title
FireHawk Bioherbicide Super Concentrate STABILITY DATA
Study date
15 July 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278728
Author
Mitchell Faint and Phillip Frost
Title
Evaluation of FireHawk Bioherbicide Super Concentrate and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for the control of seedling, broadleaf and grass weed,s Sharon, Queensland, 2024
Study date
8 May 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278729
Author
Phillip Frost, Stuart Johnson and David Kohler
Title
Evaluation of FireHawk Bioherbicide Super Concentrate and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for seedling weed control in fallow, Forth, Tasmania, 2024
Study date
15 May 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278730
Author
Ross Holding
Title
Evaluation of FireHawk Bioherbicide Super Concentrate herbicide (777g/L Nonanoic Acid) and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for control of seedling broadleaf and grass weeds.
Study date
May 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
287593
Author
Roger Franklin and Richard Hall
Title
FireHawk Bioherbicide Super Concentrate PART 8 Efficacy and Crop Safety
Study date
20 June 2025
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
287594
Author
Roger Franklin
Title
FireHawk Bioherbicide SC S159 Response
Study date
20 June 2025
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278727
Author
D J Bealing
Title
Derivation of Ecotoxicology Endpoints for FireHawk Bioherbicide Super Concentrate
Study date
3 June 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278723
Author
Not stated
Title
Appendix 4 Active and Excipient SDS
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
278725
Author
APVMA
Title
91093-130918 & 91097-130925 Contact Organics LocalSafe & FarmSafe Weed Terminator N - HHRA FTR
Study date
11 February 2022
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278726
Author
H. Eixarch
Title
Derivation of Mammalian Toxicity Classifications for FireHawk Bioherbicide Super Concentrate
Study date
30 May 2024
Authorising party
Applicant
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia