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
138136
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Typhimurium
Application Date
Application Number
138136
Application Product Name
Salmonella Enterica ser. Typhimurium
Application details
Product name:
Salmonella Enterica ser. Typhimurium
Product number:
93163
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138142
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application Date
Application Number
138142
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application details
Product name:
AviPro Salmonella Vac E Live Vaccine
Product number:
93166
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction
with approval of an active constituent.
Description of data provided:
Data no
248722
Title
In-use stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248699
Title
Appendix 1-0 Part 1 overview AviPro Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248710
Title
Starting materials of biological origin
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248716
Title
Batch record-A059400
Study date
09 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248702
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261823
Title
Residual moisture VR Salm VacE
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248719
Title
Stability overview and conclusion
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248713
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248708
Title
Validation report 0-0060-vr-ba01
Study date
03 Jan 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248714
Title
Batch to batch consistency
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248725
Title
Batch record-6093700
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248705
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248717
Title
Batch record-A059500
Study date
10 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248711
Title
Master seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248703
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248726
Title
Appendix 8-0 Part 8 overview Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261822
Title
Batch record Salm VacE
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248720
Title
Long term stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248706
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248712
Title
Working seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248723
Title
Stress stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248700
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248709
Title
Validation report 0-0060-vr-91998-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248701
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248724
Title
Batch record-6093500
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248718
Title
Batch record-G033600
Study date
29 November 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248704
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248721
Title
Relocation stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248707
Title
Validation report 0-0063-vr-110-01-01
Study date
21 March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248715
Title
Batch record-5062300
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138146
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application Date
Application Number
138146
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application details
Product name:
AviPro Salmonella Vac T Live Vaccine
Product number:
93168
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of an active constituent (secondary application).
Description of data provided:
Data no
248676
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248693
Title
Batch record-5077000
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248667
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248673
Title
Starting materials of biological origin
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248679
Title
Batch record-9101100
Study date
9 May 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248687
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248690
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248670
Title
Validation report 0-0060-vr-92059-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248674
Title
Master seed S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248682
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261824
Title
Residual moisture VR Salm VacT
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248691
Title
Batch record-5076600
Study date
1 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248688
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248665
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248671
Title
Validation report 0-0060-vr-ba01
Study date
03 January 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248694
Title
Part 8 overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248685
Title
Intermediate storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248662
Title
Part 1 application overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248668
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248680
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248686
Title
In-use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248669
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248663
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248677
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248683
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248692
Title
Batch record-5076800
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248689
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248666
Title
Product development
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248678
Title
Batch record-6005400
Study date
26 April 2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248684
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261825
Title
Batch-record Salm VacT
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248675
Title
Working see S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248681
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248672
Title
Validation report 0-0063-vr-111-01
Study date
29 March 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248664
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
134834
Product/Active constituent Name
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application Date
Application Number
134834
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application details
Product name:
Royal Canin Recovery Liquid Canine Feline
Product number:
92202
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Recovery Liquid Canine Feline', indicated for 'vet only' use in a critical care environment for dogs and cats.
Description of data provided:
Data no
234945
Title
Finished product batch analysis
Study date
September 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246306
Title
Claim substantiation - Renal Feline
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234936
Title
Certificates of Analysis_exempt active constituents
Study date
2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246309
Title
Claim substantiation - Recovery
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234942
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246303
Title
Kerry Inc. potable water source
Study date
October 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234933
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234953
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234939
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246300
Title
Recovery 15 month stability
Study date
November 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234928
Title
Release & expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234934
Title
Certificate of Analysis_finished product
Study date
October 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234940
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246301
Title
Gastrointestinal 14.5 month stability
Study date
April 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234948
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234931
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234951
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246312
Title
Ingredient classification outcome
Study date
May 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234937
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234949
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234932
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246313
Title
Silliker site certification
Study date
July 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234952
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234946
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246307
Title
Vet education webinar
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234935
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234929
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246310
Title
Claim substantiation - Gastrointestinal
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234943
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246304
Title
Lutein CoA documentation
Study date
2018
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234947
Title
Stability data
Study date
August 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246308
Title
GIT tract scientific presentation
Study date
April 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234930
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246299
Title
Renal Canine 15.25 month stability
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246311
Title
PAA advice - DCPAA2-07426157A
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234938
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234944
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246305
Title
Claim substantiation - Renal Canine
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234950
Title
AAFCO 2020 Nutritional Profiles
Study date
2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234941
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246302
Title
Appendix 2-11 replacement documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134836
Product/Active constituent Name
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application Date
Application Number
134836
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application details
Product name:
Royal Canin Gastrointestinal Low Fat Liquid Canine
Product number:
92204
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Gastrointestinal Low Fat Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Description of data provided:
Data no
235005
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234999
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235002
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235008
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234996
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235014
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235003
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234997
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234991
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234994
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235011
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235000
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234995
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235012
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235009
Title
Stability data
Study date
March 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235015
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235006
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234998
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234992
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234993
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235010
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235007
Title
Finished product batch analysis
Study date
April 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235001
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235013
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235004
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234990
Title
Release and expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134837
Product/Active constituent Name
Application Product Name
Royal Canin Renal Support Liquid Canine
Application Date
Application Number
134837
Application Product Name
Royal Canin Renal Support Liquid Canine
Application details
Product name:
Royal Canin Renal Support Liquid Canine
Product number:
92205
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Renal Support Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Description of data provided:
Data no
235022
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235016
Title
Release and expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235028
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235036
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235019
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235025
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235039
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235020
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235034
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235040
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235017
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235023
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235031
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235037
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235018
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235026
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235032
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235038
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235029
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235035
Title
Stability data
Study date
April 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235041
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235024
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235030
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235021
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235027
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235033
Title
Finished product batch analysis
Study date
March 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134838
Product/Active constituent Name
Application Product Name
Royal Canin Renal Support Liquid Feline
Application Date
Application Number
134838
Application Product Name
Royal Canin Renal Support Liquid Feline
Application details
Product name:
Royal Canin Renal Support Liquid Feline
Product number:
92206
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Renal Support Liquid Feline', indicated for 'vet only' use in a critical care environment for cats.
Description of data provided:
Data no
235062
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235056
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235048
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235042
Title
Release & expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235059
Title
Finished product batch analysis
Study date
March 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235065
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235045
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235060
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235066
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235054
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235057
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235063
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235051
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235043
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235058
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235052
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235046
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235061
Title
Stability data
Study date
October 2018
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235049
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235055
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235064
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235050
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235044
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235067
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235053
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235047
Title
Critical care liquid diets product information
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application No
Application Number
152765
Product/Active constituent Name
Application Product Name
PoolRx+ Mineral Algaecide
Application Number
152765
Application Product Name
PoolRx+ Mineral Algaecide
Application details
Product name:
PoolRx+ Mineral Algaecide
Product number:
97337
Applicant Name:
PoolRx Worldwide, Inc.
Application purpose and description of use:
Registration of a 216.7 g/kg COPPER present as COPPER SULFATE PENTAHYDRATE granular product for boosting the control of algae in chlorinated pools and spas.
Reference details:
89173 - Eezipool Smart Pool Booster Conditioner
40224 - POOL BLOCKS ALL SEASONS ALGICIDE
Description of data provided:
Data no
304897
Title
Laboratory Report
Study date
28/02/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304903
Title
Antimicrobial testing
Study date
13/4/2020
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304906
Title
Pool Blocks All Seasons Algicide 40224/1.5/0805
Study date
17/10/2005
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304900
Title
Antimicrobial testing
Study date
09/10/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304901
Title
Antimicrobial testing
Study date
12/12/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304892
Title
Information on ingredients
Study date
19/03/2026
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304898
Title
Part 2 Summary
Study date
April 2026
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304904
Title
PoolRx+ EPA registration number 79817-4
Study date
26/06/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304895
Title
Pool Units
Study date
13/11/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304907
Title
Part 8 Summary
Study date
April 2026
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304899
Title
Algaecide swimming pool field study
Study date
28/09/2021
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304896
Title
Safety Data Sheet
Study date
04/04/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304893
Title
Manufacturing process
Study date
13/11/2025
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304905
Title
Eezipool Smart Pool Booster Conditioner 89173/135515
Study date
30/05/2022
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304894
Title
Final study report for the analysis of PoolRx+ for accelerated storage stability and corrosion characteristics.
Study date
12/10/2021
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304902
Title
Antimicrobial testing
Study date
29/10/2019
Auth party contact address
1120 Via Callejon San Clemente United States
Data no
304891
Title
Certificate of analysis
Study date
08/12/2024
Auth party contact address
1120 Via Callejon San Clemente United States
Date
Application No
Application Number
154487
Product/Active constituent Name
Application Product Name
EARTHCORE GLYPHOSATE 360 WEED KILL SUITABLE AROUND PONDS
Application Number
154487
Application Product Name
EARTHCORE GLYPHOSATE 360 WEED KILL SUITABLE AROUND PONDS
Application details
Product name:
EARTHCORE GLYPHOSATE 360 WEED KILL SUITABLE AROUND PONDS
Applicant Name:
HOME TIMBER & HARDWARE GROUP PTY LTD
Application purpose and description of use:
Registration of a 360 g/L aqueous concentrate product for control of annual and perennial weeds and grasses in the home garden, including around ponds.
Date
Application No
Application Number
154489
Product/Active constituent Name
Application Product Name
EARTHCORE READY TO USE GLYPHOSATE WEED KILL SUITABLE AROUND PONDS
Application Number
154489
Application Product Name
EARTHCORE READY TO USE GLYPHOSATE WEED KILL SUITABLE AROUND PONDS
Application details
Product name:
EARTHCORE READY TO USE GLYPHOSATE WEED KILL SUITABLE AROUND PONDS
Applicant Name:
HOME TIMBER & HARDWARE GROUP PTY LTD
Application purpose and description of use:
Registration of a 7.2 g/L glyphosate liquid product for control of weeds around the home, including around ponds.
Date
Application No
Application Number
153358
Product/Active constituent Name
Application Product Name
Rappa Pyroxasulfone 850 WG Herbicide
Application Number
153358
Application Product Name
Rappa Pyroxasulfone 850 WG Herbicide
Application details
Product name:
Rappa Pyroxasulfone 850 WG Herbicide
Product number:
97513
Applicant Name:
RAPPA CROP PROTECTION PTY LTD
Application purpose and description of use:
Registration of a 850 g/kg Water Dispersible Granule WG product for the pre-emergence control of annual ryegrass,
barley grass, annual phalaris, silver grass and toad rush and suppression of certain grass weeds in wheat (not durum wheat), triticale and certain winter legume crops.
Reference details:
91028 - Eureka! Pyroxasulfone 850 Herbicide WG
63998 - SAKURA 850 WG HERBICIDE
Active constituents:
Active constituent name
90545 - Pyroxasulfone
Description of data provided:
Data no
310004
Title
Letter of Access
Study date
May 2006
Auth party contact address
13 Milroy Street BRIGHTON EAST Australia
Data no
310005
Title
SDS Combined
Study date
May 2026
Auth party contact address
13 Milroy Street BRIGHTON EAST Australia
Date
Application No
Application Number
153359
Product/Active constituent Name
Application Product Name
RCP Pyroxasulfone 850 WG Herbicide
Application Number
153359
Application Product Name
RCP Pyroxasulfone 850 WG Herbicide
Application details
Product name:
RCP Pyroxasulfone 850 WG Herbicide
Product number:
97514
Applicant Name:
RAPPA CROP PROTECTION PTY LTD
Application purpose and description of use:
Registration of a 850 g/kg Water Dispersible Granule WG product for the pre-emergence control of annual ryegrass,
barley grass, annual phalaris, silver grass and toad rush and suppression of certain grass weeds in wheat (not durum wheat), triticale and certain winter legume crops.
Reference details:
91028 - Eureka! Pyroxasulfone 850 Herbicide WG
63998 - SAKURA 850 WG HERBICIDE
Active constituents:
Active constituent name
90545 - Pyroxasulfone
Description of data provided:
Data no
310002
Title
Letter of Access
Study date
May 2006
Auth party contact address
13 Milroy Street BRIGHTON EAST Australia
Data no
310003
Title
SDSs
Study date
May 2026
Auth party contact address
13 Milroy Street BRIGHTON EAST Australia