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
141453
Product/Active constituent Name
Application Product Name
Azoxystrobin
Application Date
Application Number
141453
Application Product Name
Azoxystrobin
Application details
Product name:
Azoxystrobin
Active name:
Azoxystrobin
Applicant Name:
AGOCEANIA PTY LTD
Application purpose and description of use:
Approval of Azoxystrobin for use in agricultural chemical products.
Description of data provided:
Data no
259334
Title
Five Batches Analysis of Azoxystrobin TC
Study date
January 11, 2016
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259335
Title
DoC of Azoxystrobin TC
Study date
July 5, 2023
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259336
Title
Manufacture Process of Azoxystrobin Technical
Study date
July 5, 2023
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259339
Title
The Justification of Impurities of Azoxystrobin Technical
Study date
July 5, 2023
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259340
Title
The statement of batch size of Azoxystrobin technical in 5-batch report
Study date
July 5, 2023
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
271307
Title
Test QC results of Azoxystrobin in the random samples produced in January 2022 to May 2023
Study date
April 19, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259337
Title
Physical and chemical properties of Azoxystrobin
Study date
July 5, 2023
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259338
Title
Registration Data of Azoxystrobin
Study date
July 5, 2023
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Date
Application Date
Application No
Application Number
143286
Product/Active constituent Name
Application Product Name
Amoxyclav Suspension
Application Date
Application Number
143286
Application Product Name
Amoxyclav Suspension
Application details
Product name:
Amoxyclav Suspension
Product number:
94716
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Registration of a 50 mg/mL amoxycillin (as amoxycillin trihydrate) and 12.5 mg/mL clavulanic acid (as clavulanate potassium) powder for reconstitution as an oral suspension product for treatment of infections sensitive to clavulanic acid / amoxycillin in dogs and cats.
Reference details:
35843 - CLAVULOX PALATABLE DROPS BROAD SPECTRUM ANTIBIOTIC
Active constituents:
Active constituent name
81892 - AMOXYCILLIN TRIHYDRATE
Active constituent name
84750 - CLAVULANIC ACID (AS POTASSIUM SALT)
Description of data provided:
Data no
273858
Title
<2> Oral Drug Products ? Product Quality Tests
Study date
June 2024
Auth party contact address
-
Data no
273859
Title
<905> Uniformity of Dosage Units
Study date
June 2024
Auth party contact address
-
Data no
273860
Title
<698> Deliverable Volume
Study date
June 2024
Auth party contact address
-
Data no
268857
Title
Specification
Study date
March 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
268858
Title
Certificate of GMP Compliance of a Manufacturer
Study date
20 January 2023
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
273857
Title
Response to s159(1)(a) notice of requirement of information, report or sample
Study date
July 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
273861
Title
Permit to import conditionally non-prohibited goods
Study date
16 May 2022
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
273862
Title
List of Approved Ingredients for Retail Packaged Veterinary Therapeutics and Cosmetics for Animals
Study date
8 February 2023
Auth party contact address
-
Data no
277375
Title
Permit Application: 0009272784
Study date
5 August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
277376
Title
Tax Invoice / Receipt
Study date
5 August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Date
Application Date
Application No
Application Number
143534
Product/Active constituent Name
Application Product Name
Mesotrione
Application Date
Application Number
143534
Application Product Name
Mesotrione
Application details
Product name:
Mesotrione
Active name:
Mesotrione
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Mesotrione for use in agricultural products.
Description of data provided:
Data no
270198
Title
Mesotrione Technical (ZA1296) - Analytical Method SA-63/1
Study date
13 November 2012
Data no
270199
Title
Determination of Impurities in Mesotrione Manufacturing Use Product (ZA1296) - Analytical Method AK-225/3
Study date
18 March 2013
Data no
270196
Title
Mesotrione Technical (ZA1296) ??? Analysis of Five Representative Batches
Study date
04 April 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270197
Title
Analysis of Dimethylformamide in five Representative Batches
Study date
30 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270194
Title
Manufacturing Process Mesotrione
Study date
31 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270195
Title
Declaration of Composition
Study date
14 March 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270192
Title
Part 2 - Chemistry and Manufacture
Study date
01 April 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270193
Title
Statement on UV wavelength screening of Mesotrione (ZA1296) by Diode array
Study date
04 April 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270200
Title
Mesotrione (ZA1296) ??? Validation of analytical method SA-63/1
Study date
19 November 2013
Data no
270201
Title
Mesotrione Technical (ZA1296) ??? Revalidation of analytical method AK-225/3
Study date
24 March 2020
Date
Application Date
Application No
Application Number
143599
Product/Active constituent Name
Application Product Name
Pymetrozine
Application Date
Application Number
143599
Application Product Name
Pymetrozine
Application details
Product name:
Pymetrozine
Active name:
Pymetrozine
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of Pymetrozine Technical for use in agricultural chemical products.
Description of data provided:
Data no
270025
Title
Pymetrozine Technical: Complete Analysis of Five Batch Samples
Study date
11/10/2022
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270028
Title
Doc
Study date
25/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270029
Title
The Statement of Batch Size of Gibberellic acid Technical in 5-Batch Report
Study date
25/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270026
Title
MANUFACTURE PROCESS OF Pymetrozine TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270024
Title
Chemistry &Manufacturing Dossier
Study date
08/04/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270027
Title
THE JUSTIFICATION OF IMPURITIES OF Pymetrozine TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
143600
Product/Active constituent Name
Application Product Name
Agro-Essence Proxafone 500 SC Herbicide
Application Date
Application Number
143600
Application Product Name
Agro-Essence Proxafone 500 SC Herbicide
Application details
Product name:
Agro-Essence Proxafone 500 SC Herbicide
Product number:
94770
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 500 g/L pyroxasulfone suspension concentrate (SC) product for 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:
90907 - KENSO AGCARE KUDOS 500 SC HERBICIDE
Active constituents:
Active constituent name
88915 - pyroxasulfone
Description of data provided:
Data no
270032
Title
Pyroxosulfone - CoA
Study date
1 June 2023
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270030
Title
Part 2 - C&M - A-E proxafone 500 SC Herbicide
Study date
March 2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270033
Title
Excipient - SDSs
Study date
2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270031
Title
Accelerated Storage Stability Study of Pyroxasulfone 500 g/L SC
Study date
21 February 2023
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270034
Title
Evaluate of Agro-Essence Proxafone 500 SC Herbicide for the control of Annual Ryegrass (Lolium rigidum) in Wheat
Study date
2 February 2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270035
Title
Evaluate of Agro-Essence Proxafone 500 SC Herbicide for the control of Annual Ryegrass (Lolium rigidum) in Wheat
Study date
20 January 2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
276742
Title
Evaluate of Agro-Essence Proxafone 500 SC Herbicide for the control of Annual Ryegrass (Lolium rigidum) in lupins
Study date
7/8/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
276743
Title
PART 8 - EFFICACY AND SAFETY
Study date
09/08/2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
143083
Product/Active constituent Name
Application Product Name
MAC Slay Natural
Application Date
Application Number
143083
Application Product Name
MAC Slay Natural
Application details
Product name:
MAC Slay Natural
Product number:
94646
Applicant Name:
Arandee Limited
Application purpose and description of use:
Registration of 9 g/kg Pyrethrins aerosol with 45 g/kg piperonyl Butoxide as a synergist for the control of various Lepidopteran pests.
Reference details:
85526 - The Fly Lady Insect Spray
Active constituents:
Active constituent name
65954 - PIPERONYL BUTOXIDE
Description of data provided:
Data no
268413
Title
Certificate of Analysis - Piperonyl Butoxide
Study date
21/12/2022
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268410
Title
Certificate of Analysis - Pale Refined Pyrethrins
Study date
21/05/2020
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268411
Title
Batch Analysis Resutls - Pale refined pyrethrins
Study date
13/11/2020
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268412
Title
Batch Analysis Results - Piperonyl butoxide
Study date
17/10/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268409
Title
Chemistry & Manufacture
Study date
14/12/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268414
Title
ISO 9001:2015 Certification
Study date
05/01/2021
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268415
Title
ISO 9001:2015 Certification
Study date
27/09/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268416
Title
Product Specification
Study date
18/12/2023
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268417
Title
Quality Control Record
Study date
2024
Auth party contact address
108 Rockfield Road Penrose New Zealand
Date
Application Date
Application No
Application Number
143581
Product/Active constituent Name
Application Product Name
Tribenuron-methyl
Application Date
Application Number
143581
Application Product Name
Tribenuron-methyl
Application details
Product name:
Tribenuron-methyl
Active name:
Tribenuron-methyl
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of Tribenuron-methyl Technical for use in agricultural chemical products.
Description of data provided:
Data no
269975
Title
Study Title: Five Batch Analysis of Spiroxamine Technical
Study date
14/10/2021
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269978
Title
Doc
Study date
20/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269979
Title
2 5 The Statement of Batch Size of Spiroxamine Technical in 5-Batch Report
Study date
20/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269980
Title
CoA
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269976
Title
MANUFACTURE PROCESS OF TRIBENURON-METHYL TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269974
Title
Chemistry &Manufacturing Dossier
Study date
14/12/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269977
Title
THE JUSTIFICATION OF IMPURITIES OF TRIBENURON-METHYL TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
143585
Product/Active constituent Name
Application Product Name
Chlormequat Chloride
Application Date
Application Number
143585
Application Product Name
Chlormequat Chloride
Application details
Product name:
Chlormequat Chloride
Active name:
Chlormequat Chloride
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of Chlormequat ChlorideTechnical for use in agricultural chemical products.
Description of data provided:
Data no
269988
Title
FIVE BATCH ANALYSIS OF CHLORMEQUAT CHLORIDE TECHNICAL-Non confidential Attachment
Study date
29/06/2022
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269989
Title
FIVE BATCH ANALYSIS OF CHLORMEQUAT CHLORIDE TECHNICAL- confidential Attachment
Study date
29/06/2022
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269992
Title
Doc
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269993
Title
The Statement of Batch Size of Gibberellic acid Technical in 5-Batch Report
Study date
25/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269990
Title
MANUFACTURE PROCESS OF CHLORMEQUAT CHLORIDE TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269987
Title
Chemistry &Manufacturing Dossier
Study date
08/04/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269991
Title
THE JUSTIFICATION OF IMPURITIES OF CHLORMEQUAT CHLORIDE TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
143263
Product/Active constituent Name
Application Product Name
Mortein Freeze & Kill Multi Insect Killer
Application Date
Application Number
143263
Application Product Name
Mortein Freeze & Kill Multi Insect Killer
Application details
Product name:
Mortein Freeze & Kill Multi Insect Killer
Product number:
94705
Applicant Name:
RB (HYGIENE HOME) AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of an insecticide spray in liquid trigger format, containing 19.2g/L polyether modified polysiloxane as the active constituent, for the control of a range of insects for domestic indoor applications.
Description of data provided:
Data no
268993
Title
Method Validation Report - Quantification via HPLC-UV
Study date
25.01.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268987
Title
Supporting chemistry & manufacturing documents
Study date
12.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269003
Title
Stability Report
Study date
13.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268990
Title
Appendix 4 - Claim Support Justification
Study date
28.10.2023
Auth party contact address
680 George Street Sydney Australia
Data no
268991
Title
Appendix 2 - Certificate of Analysis
Study date
11.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268992
Title
Efficacy Substantiation Report
Study date
06.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268995
Title
Appendix 3 - Mode of Action Support
Study date
18.01.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268996
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against German Cockroach
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268997
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Trigger Formulations Against a Black Ant
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268998
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against a Brown Ant
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268999
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against House Flies
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269000
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Culex quinquefasciatus Mosquitoes
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269001
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against American Cockroach
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269002
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Aedes aegypti Mosquitoes
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268994
Title
Pre-application Assistance
Study date
2021
Auth party contact address
680 George Street Sydney Australia
Data no
268988
Title
Health Module Documents
Study date
19.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
268989
Title
Justification for the claim
Study date
14.03.2024
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
143264
Product/Active constituent Name
Application Product Name
Mortein Freeze & Kill Cockroach & Ant Killer
Application Date
Application Number
143264
Application Product Name
Mortein Freeze & Kill Cockroach & Ant Killer
Application details
Product name:
Mortein Freeze & Kill Cockroach & Ant Killer
Product number:
94706
Applicant Name:
RB (HYGIENE HOME) AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of an insecticide spray in liquid trigger format, containing 24 g/L polyether modified polysiloxane as the active constituent, for the control of a range of insects for domestic indoor applications.
Description of data provided:
Data no
269005
Title
Method Validation Report - Quantification via HPLC-UV
Study date
25.01.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269006
Title
Supporting Chemistry & Manufacturing Documents
Study date
12.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269004
Title
Stability Report
Study date
13.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269009
Title
Efficacy Substantiation Report
Study date
06.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269010
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Trigger Formulations Against a Black Ant
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269011
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against a Brown Ant
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269012
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against American Cockroach
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269013
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against German Cockroach
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269014
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Culex quinquefasciatus Mosquitoes
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269015
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against House Flies
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269016
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Aedes aegypti Mosquitoes
Study date
16.02.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269017
Title
Appendix 2 - Certificate of Analysis
Study date
11.04.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269018
Title
Appendix 3 - Mode of Action Support
Study date
18.01.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269019
Title
Appendix 4 - Claim Support Justification
Study date
28.10.2023
Auth party contact address
680 George Street Sydney Australia
Data no
269020
Title
Pre-application Assistance
Study date
2021
Auth party contact address
680 George Street Sydney Australia
Data no
269007
Title
Health module documents
Study date
19.03.2024
Auth party contact address
680 George Street Sydney Australia
Data no
269008
Title
Justification for the claim
Study date
14.03.2024
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
143528
Product/Active constituent Name
Application Product Name
Fosetyl-aluminium
Application Date
Application Number
143528
Application Product Name
Fosetyl-aluminium
Application details
Product name:
Fosetyl-aluminium
Active name:
Fosetyl-aluminium
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of Fosetyl-aluminium Technical for use in agricultural chemical products.
Description of data provided:
Data no
269873
Title
Fosetyl-aluminium Technical: Complete Analysis of Five Batch Samples
Study date
September 23, 2022
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269876
Title
Doc
Study date
19/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269877
Title
The Statement of Batch Size of Fosetyl-aluminium Technical in 5-Batch Report
Study date
19/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269878
Title
CoA
Study date
20/01/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269874
Title
MANUFACTURE PROCESS OF FOSETYL-ALUMINIUM TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269872
Title
Chemistry &Manufacturing Dossier
Study date
14/12/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269875
Title
THE JUSTIFICATION OF IMPURITY OF FOSETYL-ALUMINIUM TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
143530
Product/Active constituent Name
Application Product Name
Bromoxynil heptanoate
Application Date
Application Number
143530
Application Product Name
Bromoxynil heptanoate
Application details
Product name:
Bromoxynil heptanoate
Active name:
Bromoxynil heptanoate
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Approval of a new source of bromoxynil heptanoate for use in agricultural chemical products.
Description of data provided:
Data no
269882
Title
Analysis of Active Ingredient and Impurities in Five Batches Bromoxynil Heptanoate TC - Part 1
Study date
5 January 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269883
Title
Analysis of Active Ingredient and Impurities in Five Batches Bromoxynil Heptanoate TC - Part 2
Study date
5 January 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269888
Title
Bromoxynil Heptanoate Chemistry 3
Study date
March 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269884
Title
Bromoxynil Heptanoate Discussion of Formation of Impurities
Study date
April 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269885
Title
Bromoxynil Heptanoate Manufacturing Process
Study date
April 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269886
Title
Bromoxynil Heptanoate SDS
Study date
April 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269887
Title
Bromoxynil Heptanoate Declaration of Composition
Study date
26 March 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
142938
Product/Active constituent Name
Application Product Name
Chromium methionine complex
Application Date
Application Number
142938
Application Product Name
Chromium methionine complex
Application details
Product name:
Chromium methionine complex
Product number:
94610
Applicant Name:
FEEDWORKS PTY LTD
Application purpose and description of use:
Registration of Availa Chromium powder product as a nutritional supplement to improve productivity of ruminants, pigs, poultry and fin fish, in conjunction with approval of chromium methionine(active constituent).
Description of data provided:
Data no
277250
Title
Method of Analysis
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277259
Title
AOAC 2006.03 ICP-OES
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277260
Title
AOAC 999.13- Methionine
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277251
Title
Batch to Batch - Availa Cr
Study date
3 January 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277252
Title
SAL Chromium CoA_AvCr1000_5 lots
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277253
Title
SAL Methionine CoA_AvCr1000_5 lots
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277254
Title
CoA_Availa Cr Active Substance_EPL16207A
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277255
Title
CoA_Availa Cr Active Substance_EPL 16207C
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277256
Title
CoA_Availa Cr Active Substance_EPL 16207D
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277258
Title
CoA_Availa Cr Active Substance_EPL 16207E
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277243
Title
IFF Availa Cr PSD (partcile size distribution)
Study date
27 June 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277244
Title
Availa Cr 3 PSD & dust
Study date
21 December 2022
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277245
Title
Availa Cr 3 - Heavy metals
Study date
27 January 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277246
Title
CoA heavy Metals Availa Cr 1000
Study date
13 March 2019
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277247
Title
ISO Certificate Issue 15 2021-2024
Study date
23 January 2021
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277248
Title
HACCP Certificate Garner November 22nd 2023
Study date
20 September 2022
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277249
Title
FAMI-QS Certificate 2020-2023
Study date
1 October 2020
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277335
Title
OECD 471 BioRel_Bacterial Reverse Mutation
Study date
Dec 2008
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277336
Title
OECD 487 CERB_In Vitro micronucleus test_Cr-DL-Meth
Study date
Nov 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277337
Title
OECD 474 BioRel_Mouse bone marrow
Study date
Nov 2008
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277338
Title
Interactions between chromium(III) and iron(III), molybdenum(III) or nickel(II): Cytotoxicity, genotoxicity and mutagenicity studies
Study date
2018
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277339
Title
The genotoxicity of physiological concentrations of chromium (Cr(III) and Cr(VI)) and cobalt (Co(II)): An in vitro study
Study date
2010
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277340
Title
Chromium-Induced Genotoxicity and Interference in Human Lymphoblastoid Cell (TK6) Repair Processes
Study date
2011
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277341
Title
Genotoxicity assessment of chromium(III) propionate complex in the rat model using the comet assay
Study date
2010
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277342
Title
Genotoxicity of Tri- and Hexavalent Chromium Compounds In Vivo and Their Modes of Action on DNA Damage In Vitro
Study date
2014
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277343
Title
Cr-(III)-organic compounds treatment causes genotoxicity and changes in DNA and protein level in Saccharomyces cerevisiae
Study date
2010
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277344
Title
Intracellular and Extracellular Factors Influencing Cr(VI) and Cr(III) Genotoxicity
Study date
2012
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Date
Application Date
Application No
Application Number
143500
Product/Active constituent Name
Application Product Name
BENAZEMAV FLAVOURED 20MG TABLETS FOR DOGS
Application Date
Application Number
143500
Application Product Name
BENAZEMAV FLAVOURED 20MG TABLETS FOR DOGS
Application details
Product name:
BENAZEMAV FLAVOURED 20MG TABLETS FOR DOGS
Product number:
69454
Applicant Name:
CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED
Application purpose and description of use:
Variation of product registration and label approval to update relevant particulars.
Description of data provided:
Data no
275660
Title
Benazemav 20 - FPS v2
Study date
2024
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269385
Title
Comparative Table
Study date
2024
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269376
Title
Benazemav 20 - FPS
Study date
2024
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269377
Title
2a-qual-quant-partic-proposed
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269378
Title
2f2-fin-prod
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269379
Title
Stability Data 1
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269380
Title
Stability Data 2
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269381
Title
Stability Data 3
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269382
Title
Stability Data 4
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269383
Title
Stability Commitment
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269384
Title
2c3-cont-clos-sys
Study date
2023
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Date
Application Date
Application No
Application Number
142939
Product/Active constituent Name
Application Product Name
Availa Chromium
Application Date
Application Number
142939
Application Product Name
Availa Chromium
Application details
Product name:
Availa Chromium
Product number:
94611
Applicant Name:
FEEDWORKS PTY LTD
Application purpose and description of use:
Registration of Availa Chromium powder product as a nutritional supplement to improve productivity of ruminants, pigs, poultry and fin fish, in conjunction with approval of chromium methionine(active constituent).
Description of data provided:
Data no
267412
Title
MSS Chromium & Methionine CoA_AvCr_HPA17165
Study date
July 2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267423
Title
Complexed Chromium analytical method
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267418
Title
Homogeneity AvCr final report ws 20161028
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267384
Title
Manufacturing process
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267401
Title
SAL Dioxin CoA AvCr1000
Study date
26 September 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267402
Title
SAL Dioxin CoA_ AvCr1000_HPA16142
Study date
22 January 2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267403
Title
Availa Cr 3 - Dioxins
Study date
27/01/2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267404
Title
SAL Micro & Fluoride_AvCR1000_3 lots
Study date
26/09/2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267405
Title
Availa Cr 3 -Microbiology
Study date
19/12/2022
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267406
Title
SAL Mycotoxin CoA_AvCr1000 3 lots
Study date
26/09/2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267407
Title
IFF_Availa Cr_Density
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267408
Title
Availa Cr 3-Bulka Density
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267409
Title
IFF supplementary PSD & chromium content of dust
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267419
Title
Homogeneity of Availa Cr in pelleted feeds_final report
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277178
Title
II.3.1 Availa Cr
Study date
20/6/2013
Data no
277179
Title
II.3.2 Availa Cr
Study date
24/5/2012
Data no
277180
Title
II.3.3 Availa Cr
Study date
7/6/2012
Data no
277181
Title
II.3.4 Availa Cr
Study date
17/1/2012
Data no
277182
Title
II.3.5 Availa Cr
Study date
19/6/2015
Data no
267400
Title
Atability Availa Cr
Study date
20 October 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276500
Title
Effects of diets high in simple sugars on urinary chromium losses.
Study date
June 1986
Auth party contact address
-
Data no
275528
Title
esfa Safety and efficacy of chromium methionine Availa Cr as feed additive for all species.
Study date
29 April 2009
Auth party contact address
-
Data no
267437
Title
Efficacy of Chromium-DL-Methionine in Dairy Cows
Study date
2 November 2016
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267438
Title
Efficacy study of Availa-Cr in Broilers
Study date
18 March 2020
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267439
Title
Efficacy of Availa Cr in Atlantic Salmon
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267440
Title
Efficacy of chromium DL-methionine in Rainbow Trout
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267441
Title
Application dossier for Australia. Chromium Chelate of DL Methionine Efficay- edited Summary
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267442
Title
Effects of Cr methionine of supplementation on grower-finisher pigs
Study date
2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276592
Title
Carcass characteristics and tissue-mineral contents of steers fed supplemental chromium.
Study date
1992
Auth party contact address
-
Data no
267392
Title
Safety for consumers
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267391
Title
Safety for target animals
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267424
Title
Efficacy & tolerance Availa Cr rainbow trout
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267425
Title
Tolerance of Dairy Cows to Availa-Cr
Study date
March 2018
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267426
Title
Efficacy & Tolerance studyof Availa-Cr in Broilers
Study date
March 2020
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276501
Title
Production and carcase traits in broiler chickens given diets supplemented with inorganic trivalent chromium and an organic acid blend.
Study date
March 2008
Auth party contact address
-
Data no
276502
Title
Effects of starch, sucrose, fructose and glucose on chromium absorption and tissue concentrations in obese and lean mice.
Study date
Oct 1989
Auth party contact address
-
Data no
276498
Title
Dietary Chromium-methionine Chelate Supplementation and Animal Performance
Study date
16 Aug, 2022
Auth party contact address
-
Data no
267394
Title
Safety for environment
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267395
Title
Efficacy
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267414
Title
CoA_Availa Cr Active Substance_EPL 16207B
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277176
Title
Manufacturing Process and Site Declaration
Study date
13 Aug, 2024
Data no
277177
Title
Australia APVMA Supplementary information request letter May2024
Study date
9 May, 2024
Data no
267383
Title
Application Australia - Chromiun Chelate of DL Methionine
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267390
Title
Conditions of Use
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
275529
Title
5- Availa Cr - related to point 5
Study date
3 July 2024
Data no
275530
Title
6- Availa Cr 1000 and Availa Cr 3%
Study date
3 July 2024
Data no
275531
Title
7- Availa Cr- related to point 7
Study date
3 july 2024
Data no
275532
Title
8- 20190904 FDA Inspection report and closing letter Garner received 20200413
Study date
4 Sep 2019
Data no
276700
Title
Current Good manufacturing Practice Certificate (CGMP)Manufacturing
Study date
March 28, 2024
Data no
276576
Title
Anti-diabetic properties of chromium citrate complex in alloxan-induced diabetic rats.
Study date
December 2011
Auth party contact address
-
Data no
276503
Title
Distribution in the rat of physiological amounts of injected Cr51(III) with time.
Study date
1 Oct 1965
Auth party contact address
-
Data no
276504
Title
Biological activity and fate of trace quantities of intravenous chromium (III) in the rat
Study date
1 September 1965
Auth party contact address
-
Data no
276493
Title
Estimation of chromium bioavailability from the diet by an in vitro method.
Study date
July 2001
Auth party contact address
-
Data no
276494
Title
Determination of daily dietary intake of chromium by duplicate diet sampling: in vitro availability study
Study date
12 September 2007
Auth party contact address
-
Data no
276496
Title
Dietary chromium effects on tissue chromium concentrations and chromium absorption in rats.
Study date
July 1996
Auth party contact address
-
Data no
276508
Title
The time-dependent transport of chromium in adult rats from the bloodstream to the urine.
Study date
27 April, 2005
Auth party contact address
-
Data no
276512
Title
Compartment analysis of metabolism of chromium(III) in rats of various ages.
Study date
01 May, 1977
Auth party contact address
-
Data no
276524
Title
Tissue chromium exchange in the rat.
Study date
October, 1981
Auth party contact address
-
Data no
276525
Title
Transport of methionine hydroxy analog across the brush border membrane of rat jejunum.
Study date
July 1987
Auth party contact address
-
Data no
276522
Title
Study on the metabolism of physiological amounts of Cr(III) intragastrical administration in normal rats using activable enriched stable isotope Cr-50 compound as a tracer.
Study date
21 January, 1998
Auth party contact address
-
Data no
276549
Title
Absorption, excretion and retention of 51Cr from labelled Cr-(III)-picolinate in rats
Study date
Apr 2009
Auth party contact address
-
Data no
276562
Title
Lack of toxicity of chromium chloride and chromium picolinate in rats.
Study date
1997
Auth party contact address
-
Data no
276563
Title
Efficacy of chromium(III) supplementation on growth, body composition, serum parameters, and tissue chromium in rats
Study date
Oct 2007
Auth party contact address
-
Data no
276567
Title
Bioavailability of chromium(III)-supplements in rats and humans
Study date
Oct 2012
Auth party contact address
-
Data no
276573
Title
Effects of Chromium Histidinate on Renal Function, Oxidative Stress, and Heat-Shock Proteins in Fat-Fed and Streptozotocin-Treated Rats.
Study date
March 2010
Auth party contact address
-
Data no
276574
Title
Chromium dinicocysteinate supplementation can lower blood glucose, CRP, MCP-1, ICAM-1, creatinine, apparently mediated by elevated blood vitamin C and adiponectin and inhibition of NFkB, Akt, and Glut-2 in livers of Zucker diabetic fatty rats
Study date
Sep 2010
Auth party contact address
-
Data no
276579
Title
Impact of chromium histidinate on high fat diet induced obesity in rats.
Study date
May 2011
Auth party contact address
-
Data no
276580
Title
Interactions between chromium(III) and iron(III), molybdenum(III) or nickel(II): Cytotoxicity, genotoxicity and mutagenicity studies
Study date
June 2018
Auth party contact address
-
Data no
276581
Title
The genotoxicity of physiological concentrations of chromium (Cr(III) and Cr(VI)) and cobalt (Co(II)): an in vitro study.
Study date
June 2010
Auth party contact address
-
Data no
276582
Title
Chromium-induced genotoxicity and interference in human lymphoblastoid cell (TK6) repair processes.
Study date
2011
Auth party contact address
-
Data no
276583
Title
Genotoxicity assessment of chromium(III) propionate complex in the rat modelusing the comet assay
Study date
January, 2010
Auth party contact address
-
Data no
276575
Title
Insulin and chromium picolinate induce translocation of CD36 to the plasma membrane through different signaling pathways in 3T3-L1 adipocytes, and with a differential functionality of the CD36.
Study date
Sep 2011
Auth party contact address
-
Data no
276560
Title
The Effect of Supplemental Dietary Chromium on Performance, Some Blood Parameters and Tissue Chromium Contents of Some Blood Parameters and Tissue Chromium Contents of Rabbits .
Study date
1 January 2001
Auth party contact address
-
Data no
276568
Title
Safe Upper Levels for Vitamins and Minerals
Study date
May 2003
Auth party contact address
-
Data no
276569
Title
Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc.
Study date
2001
Auth party contact address
-
Data no
276570
Title
RDA Workshop: New Approaches, Endpoints and Paradigms for RDAs of Mineral Elements.- Safety Limits for Nutrients1'2
Study date
1996
Auth party contact address
-
Data no
276571
Title
Toxicological Profile for Manganese
Study date
Sep 2012
Auth party contact address
-
Data no
276572
Title
Collate literature data on toxicity of Chromium (Cr) and Nickel (Ni) in experimental animals and humans.
Study date
12 February, 2015
Auth party contact address
-
Data no
276564
Title
Selected trace and ultratrace elements: Biological role, content in feed and requirements in animal nutrition ? Elements for risk assessment.
Study date
28 July, 2010
Auth party contact address
-
Data no
276565
Title
Recommended Dietary Allowances: 10th Edition
Study date
1989
Auth party contact address
-
Data no
276566
Title
Improved glucose control associated with i.v. chromium administration in two patients receiving enteral nutrition
Study date
Apr 2010
Auth party contact address
-
Data no
276554
Title
Beneficial effects of chromium on glucose and lipid variables in control and somatotropin-treated pigs are associated with increased tissue chromium and altered tissue copper, iron, and zinc.
Study date
3 March 1997
Auth party contact address
-
Data no
276539
Title
Assessment of blood chemistry normal ranges in rainbow trout.
Study date
23 May 2006
Auth party contact address
-
Data no
276540
Title
In vitro oxidative decarboxylation of L-2-hydroxy-4-methylthiobutanoic acid by L-2-hydroxy acid oxidase A from chicken liver.
Study date
1995
Auth party contact address
-
Data no
276543
Title
The in vivo sparing of methionine by cysteine in sulfur amino acid requirements in animal models and adult humans.
Study date
June, 2006
Auth party contact address
-
Data no
276544
Title
Biochemistry of sulfur-containing amino acids.
Study date
1983
Auth party contact address
-
Data no
276545
Title
Methionine transamination in vivo.
Study date
1 Sep 1989
Auth party contact address
-
Data no
276546
Title
The sulfur-containing amino acids: an overview.
Study date
June, 2006
Auth party contact address
-
Data no
276547
Title
The effect of methanethiol and methionine toxicity on the activities of cytochrome c oxidase and enzymes involved in protection from peroxidative damage
Study date
Feb, 1986
Auth party contact address
-
Data no
276523
Title
Bioavailability of lysine in L-lysine.HCl
Study date
Oct 1988
Auth party contact address
-
Data no
276528
Title
Absorption and Bioavailability of DL-Methionine Hydroxy Analog Compared to DL-Methionine.
Study date
1 February, 1990
Auth party contact address
-
Data no
276531
Title
Monocarboxylate transporter 1 mediates DL-2-Hydroxy-(4-methylthio)butanoic acid transport across the apical membrane of Caco-2 cell monolayers.
Study date
Jan 2007
Auth party contact address
-
Data no
276513
Title
The trail of Chromium (III) in vivo from the blood to the urine: the roles of transferrin and chromodulin.
Study date
21 April, 2001
Auth party contact address
-
Data no
276516
Title
Acute and chronic resistive exercise increase urinary chromium excretion in men as measured with an enriched chromium stable isotope.
Study date
Jan 1998
Auth party contact address
-
Data no
276517
Title
Essentiality of chromium in humans.
Study date
Oct 1989
Auth party contact address
-
Data no
276518
Title
Renal excretion of chromium-51 chloride in the dog.
Study date
June 1984
Auth party contact address
-
Data no
276519
Title
Chromium (III) metabolism by the kidney.
Study date
1981
Auth party contact address
-
Data no
276520
Title
Biochemistry of the Essential Ultratrace Elements.
Study date
1984
Auth party contact address
-
Data no
276521
Title
The Nutritional Biochemistry of Chromium(III)
Study date
21 March, 2007
Auth party contact address
-
Data no
276509
Title
Reduced chromium retention in patients with hemochromatosis, a possible basis of hemochromatotic diabetes.
Study date
January 1979
Auth party contact address
-
Data no
276510
Title
Effects of over-the-counter drugs on 51chromium retention and urinary excretion in rats
Study date
February 1995
Auth party contact address
-
Data no
276511
Title
Evidence for synergism between chromium and nicotinic acid in the control of glucose tolerance in elderly humans
Study date
September, 1987
Auth party contact address
-
Data no
276497
Title
Opinion of the Scientific Committee on food on the tolerable upper intake level of trivalent chromium.
Study date
4 April, 2003
Auth party contact address
-
Data no
276499
Title
Comparison of acute absorption of commercially available chromium supplements.
Study date
26 January, 2007
Auth party contact address
-
Data no
276495
Title
Chromium intake, absorption and excretion of subjects consuming self-selected diets
Study date
June 1985
Auth party contact address
-
Data no
276505
Title
Study of chromium-containing proteins in subcellular fractions of rat liver by enriched stable isotopic tracer technique and gel filtration chromatography.
Study date
16 January, 2003
Auth party contact address
-
Data no
276506
Title
Chromium (III) binding to serum proteins, specifically siderophilin
Study date
4 September, 1964
Auth party contact address
-
Data no
276507
Title
Kinetics of trace element chromium(III) in the human body.
Study date
April, 1983
Auth party contact address
-
Data no
276481
Title
Interactions between chromium (ii) and Iron(iii), molybdenum (iii) or nickel (ii): Cytotoxicity,, genotoxicity and mutagenicity studies.
Study date
14 January 2018
Auth party contact address
-
Data no
276482
Title
The genotoxicity of physiological concentrations of chromium (Cr(iii) and Cr(vi)) and Cobalt (Co(ii)): An in vitro study.
Study date
2010
Auth party contact address
-
Data no
276484
Title
Genotoxicity assessment of chromium (iii) propionate complex in the rat model using the comet assay.
Study date
11 Sep 2009
Auth party contact address
-
Data no
276485
Title
Evaluation of the safety a Chromium (iii) Phosphate suspension for radiosynoviorthesis.
Study date
9 April, 2013
Auth party contact address
-
Data no
276486
Title
Genotoxicity of tri- and hexavalent chromium compounds In vivo and their modes of action on DNA damage in vitro.
Study date
26 June 2014
Auth party contact address
-
Data no
276487
Title
Cr-(iii) - organic compounds treatment causes genotoxicity and changes in DNA and protein level in Saccharomyces cerevisiae.
Study date
14 September, 2009
Auth party contact address
-
Data no
276488
Title
Intracellular and extracellular factors influencing Cr (vi) and Cr (iii) genotoxicity.
Study date
21 Oct 2011
Auth party contact address
-
Data no
276489
Title
Chronic toxicity and carcinogenicity studies of chromium picolinate monohydrate administered in feed to F344/N rats and B6C3F1 mice for 2 years.
Study date
8 Jan, 2009
Auth party contact address
-
Data no
276490
Title
Safety and efficacy of chromium methionine (Availa Cr) as feed additive for all species.
Study date
1 April 2009
Auth party contact address
-
Data no
276491
Title
Effect of chelating agents on chromium absorption in rats.
Study date
Aug 1973
Auth party contact address
-
Data no
276492
Title
Absorption of inorganic, trivalent chromium from the vascularly perfused rat small intestine.
Study date
Aug 1989
Auth party contact address
-
Data no
276577
Title
Effects of carbohydrate and chromium ingestion during intermittent high-intensity exercise to fatigue.
Study date
Dec 2000
Auth party contact address
-
Data no
276578
Title
Scientific Opinion on ChromoPrecise? cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source
Study date
23 November, 2012
Auth party contact address
-
Data no
276591
Title
Evaluation of Bioavalability of Chromium from various organic sources.
Study date
2002
Data no
267443
Title
Application dossier for Australia. Chromium Chelate of DL Methionine. Metabolism and Kinetics
Study date
October 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
276514
Title
Scientific Opinion on DL-methionine, DL-methionine sodium salt, the hydroxy analogue of methionine and the calcium salt of methionine hydroxy analogue in all animal species; on the isopropyl ester of methionine hydroxy analogue and DL-methionine technically pure protected with copolymer vinylpyridine/styrene in dairy cows; and on DL-methionine technically pure protected with ethylcellulose in rumi
Study date
30 March, 2012
Auth party contact address
-
Data no
276515
Title
Invited review: Amino acid bioavailability and digestibility in pig feed ingredients: Terminology and application
Study date
12 March, 2015
Auth party contact address
-
Data no
276532
Title
Partial Na+ Dependence of dl-2-Hydroxy-4-(Methylthio)Butanoic Acid Uptake in the Chicken Small Intestine.
Study date
1 July, 2008
Auth party contact address
-
Data no
276533
Title
Absorption of methionine and 2-hydroxy-4-methylthiobutoanic acid in conventional and germ-free chickens
Study date
1 July, 2003
Auth party contact address
-
Data no
276534
Title
Apparent absorption of methionine and 2-hydroxy-4-methylthiobutanoic acid from gastrointestinal tract of conventional and gnotobiotic pigs.
Study date
Oct 2009
Auth party contact address
-
Data no
276535
Title
Conversion of 2-hydroxy-4-(methylthio)butanoic acid to L-methionine in the chick: a stereospecific pathway
Study date
September 1984
Auth party contact address
-
Data no
276536
Title
Comparative in vitro and in vivo absorption of 2-hydroxy-4(methylthio) butanoic acid and methionine in the broiler chicken.
Study date
1 September, 2005
Auth party contact address
-
Data no
276537
Title
Conversion of Methionine Hydroxy Analogue to Methionine in the Chick.
Study date
1 May, 1965
Auth party contact address
-
Data no
276538
Title
Oxidation of methionine and 2-hydroxy 4-methylthiobutanoic acid stereoisomers in chicken tissues.
Study date
July, 1989
Auth party contact address
-
Data no
276529
Title
Methionine and 2-hydroxy-4-methylthiobutanoic acid are transported by distinct Na(+)-dependent and H(+)-dependent systems in the brush border membrane of the chick intestinal epithelium.
Study date
Feb, 1996
Auth party contact address
-
Data no
276530
Title
Oligomers Are Not the Limiting Factor in the Absorption of DL-2-Hydroxy-4-(methylthio)butanoic Acid in the Chicken Small Intestine.
Study date
1 January, 2006
Auth party contact address
-
Data no
276526
Title
Na+-independent and nonstereospecific transport of 2-hydroxy 4-methylthiobutanoic acid by brush border membrane vesicles from chick small intestine.
Study date
1989
Auth party contact address
-
Data no
276527
Title
Apparent and true amino acid digestibility of a crystalline amino acid mixture and of casein: comparison of values obtained with ileal-cannulated pigs and cecectomized cockerels.
Study date
Dec 1992
Auth party contact address
-
Data no
276548
Title
Effect of chromium source on tissue concentration of chromium in pigs
Study date
Nov 2008
Auth party contact address
-
Data no
276541
Title
Conversion of the Methionine Hydroxy Analogue dl-2-Hydroxy-(4-Methylthio) Butanoic Acid to Sulfur-Containing Amino Acids in the Chicken Small Intestine.
Study date
1 November, 2006
Auth party contact address
-
Data no
276542
Title
Transamination of 2-oxo-4-[methylthio]butanoic acid in chicken tissues
Study date
Jan 1998
Auth party contact address
-
Data no
276555
Title
Effect of Chromium Nanoparticle on Growth Performance, Carcass Characteristics, Pork Quality and Tissue Chromium in Finishing Pigs.
Study date
2004
Auth party contact address
-
Data no
276556
Title
Chromium supplementation of turkeys: effects on tissue chromium.
Study date
1 January, 1989
Auth party contact address
-
Data no
276557
Title
Effects of dietary chromium picolinate supplementation on serum and tissue mineral contents of laying Japanese Quails.
Study date
12 July, 2002
Auth party contact address
-
Data no
276558
Title
Effects of dietary chromium supplementation on performance, carcass traits, serum metabolites, and tissue chromium levels of Japanese quails.
Study date
2005
Auth party contact address
-
Data no
276559
Title
The effect of dietary supplementation with trivalent chromium on production performance of laying hens and the chromium content in the yolk.
Study date
21 April, 2003
Auth party contact address
-
Data no
276550
Title
Effect of supplemental chromium on tissue chromium concentrations in cattle.
Study date
January 2004
Auth party contact address
-
Data no
276551
Title
Effect of chromium supplementation on production and metabolic parameters in periparturient dairy cows.
Study date
May 2001
Auth party contact address
-
Data no
276552
Title
Oxidation of the supplemental methionine source L-2-hydroxy-4-methylthiobutanoic acid by pure L-2-hydroxy acid oxidase from chicken liver.
Study date
Oct 1990
Auth party contact address
-
Data no
276553
Title
A regional evaluation of chromium tripicolinate supplementation of diets fed to reproducing sows.
Study date
October 2004
Auth party contact address
-
Data no
276561
Title
Effects of dietary chromium picolinate supplementation on serum glucose, cholesterol and minerals of rainbow trout (Oncorhynchus mykiss).
Study date
10 December, 2005
Auth party contact address
-
Data no
276589
Title
Effects of Chromium Methionine Supplementation with Different Sources of Zinc on Growth Performance, Carcass Traits, Meat Quality, Serum Metabolites, Endocrine Parameters, and the Antioxidant Status in Growing-Finishing Pigs
Study date
Jan 2021
Auth party contact address
-
Data no
276590
Title
Dietary chromium supplementation for Pigs and Chickens.
Study date
1995
Auth party contact address
-
Data no
267420
Title
MSDS Availa Cr v1.0
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267393
Title
Safety for Users
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267452
Title
Cr Position Statement
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267430
Title
OECD 476 BioRel_In Vitro gene mutation test_Cr-DL-Meth
Study date
Dec 2008
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267436
Title
Availa Cr 3 - Acute eye irritation OECD 405
Study date
7 March 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267433
Title
Availa Cr 1000 - Acute eye irritation OECD 405
Study date
13 December 2017
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267432
Title
Availa Cr 1000 -Acute skin irritation OECD 404
Study date
2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267434
Title
Availa Cr 1000 - Skin sensitisation OECD 406
Study date
10 April 2019
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267435
Title
Availa Cr 3 - Acute skin irritation OECD 404
Study date
7 March 2023
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267451
Title
Chronic Toxicity and Carcinogenicity Studies of Chromium Picolinate Monohydrate Administered in Feed to F344/N Rats and B6C3F1 Mice for 2 Years
Study date
2009
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
267431
Title
OECD 408 ATPL_90 day Repeat Dose Toxicity tudy
Study date
Jan 2009
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Date
Application Date
Application No
Application Number
143103
Product/Active constituent Name
Application Product Name
Molidustat sodium
Application Date
Application Number
143103
Application Product Name
Molidustat sodium
Application details
Product name:
Molidustat sodium
Active name:
Molidustat sodium
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Approval of molidustat for use in veterinary chemical products.
Description of data provided:
Data no
267754
Title
Validation of test methods - Residual solvents.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267755
Title
Validation of test for microbial purity.
Study date
25 May 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267756
Title
Validation of test methods - other methods.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267757
Title
Method development.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267752
Title
Validation of test for assay and impurities.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267786
Title
Batch analysis for intermediates.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267787
Title
Batch analysis for intermediates.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267788
Title
Batch analysis for intermediates.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267758
Title
Batch analyses.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267759
Title
Batch analyses - development.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267777
Title
Certificate of analysis.
Study date
20 February 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267778
Title
Certificate of analysis.
Study date
20 February 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267779
Title
Certificate of analysis.
Study date
20 February 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267735
Title
Control of materials - Starting materials - Batch analyses.
Study date
7 June 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267736
Title
Control of materials - Starting materials - Batch analyses.
Study date
6 June 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267737
Title
Control of materials - Starting materials - Batch analyses.
Study date
6 June 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267738
Title
Quality reference.
Study date
31 March 2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267739
Title
Raw material specification.
Study date
9 May 2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267740
Title
Raw material specification.
Study date
31 March 2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267741
Title
Raw material specification.
Study date
2 May 2008
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267742
Title
Raw material specification.
Study date
22 December 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267743
Title
Raw material specification.
Study date
9 June 2010
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267744
Title
Manufacturing process development.
Study date
8 September 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267713
Title
Manufacturing process - Flow diagram.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267714
Title
Manufacturing process - Description.
Study date
5 July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267715
Title
Manufacturing process - Description.
Study date
5 July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267716
Title
Manufacturing process - Description.
Study date
5 July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267717
Title
Manufacturing process - Physical treatment.
Study date
22 June 202
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267718
Title
Raw materials.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267719
Title
Raw material - specification.
Study date
30 October 2013
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267720
Title
Raw material - specification.
Study date
7 September 2015
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267721
Title
Raw material - specification.
Study date
15 February 2016
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267722
Title
Raw material - specification.
Study date
29 April 2016
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267723
Title
Raw material - specification.
Study date
4 December 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267724
Title
Raw material - specification.
Study date
15 July 2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267725
Title
Raw material - specification.
Study date
15 November 2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267726
Title
Raw material - specification.
Study date
15 November 2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267727
Title
Raw material - specification.
Study date
12 December 2019
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267728
Title
Justification of starting materials.
Study date
8 September 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267729
Title
Flow chart of the starting material.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267730
Title
Flow chart of the starting material.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267731
Title
Flow chart of the starting material.
Study date
6 July 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267732
Title
Control of materials - starting materials - specification.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267733
Title
Control of materials - starting materials - specification.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267734
Title
Control of materials - starting materials - specification.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267781
Title
Discussion and control of critical steps.
Study date
8 September 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267782
Title
List of intermediates.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267783
Title
Control of intermediates.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267784
Title
Control of intermediates.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267785
Title
Control of intermediates.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267780
Title
Certificate of Composition.
Study date
1 March 2024
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267706
Title
Quality overall summary on the Pharmaceutical Documentation Module 2.3.S.
Study date
July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267707
Title
TSE assessment - substance.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267708
Title
Labeling of the immediate/shipping container for the bulk drug substance.
Study date
28 June 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267709
Title
General information - Nomenclature.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267710
Title
General information - Structure.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267711
Title
General information - General properties.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267712
Title
Manufacturer(s).
Study date
25 September 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267772
Title
Specification.
Study date
4 May 2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267773
Title
Test procedure.
Study date
4 May 2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267774
Title
Description of the primary packaging material.
Study date
20 July 2017
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267775
Title
Release results of several batches.
Study date
20 July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267760
Title
Justification of specification.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267761
Title
Reference standard.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267762
Title
Reference standards - impurities.
Study date
12 July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267763
Title
Packaging materials.
Study date
29 June 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267745
Title
Structure elucidation and other characteristics.
Study date
12 July 2021
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267746
Title
Information on polymorphism.
Study date
22 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267747
Title
Impurities.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267748
Title
Impurities - Residual solvents.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267749
Title
Risk assessment of elemental impurities.
Study date
30 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267750
Title
Specification.
Study date
10 October 2022
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267751
Title
Test procedure.
Study date
25 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267753
Title
Validation of test for particle size determination.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267764
Title
Stability summary and conclusion.
Study date
1 September 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267765
Title
Stability summary and conclusion.
Study date
1 September 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267766
Title
Post-approval stability protocol and stability commitment.
Study date
1 September 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267767
Title
Retest period.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267768
Title
Post-approval stability protocol and stability commitment.
Study date
1 September 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267769
Title
Stability data.
Study date
11 September 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267770
Title
Stability data - stress tests.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267771
Title
Stability data - photostability.
Study date
29 June 2020
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267776
Title
Safety data Sheet: Molidustat sodium.
Study date
24 January 2023
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
143504
Product/Active constituent Name
Application Product Name
BUPRELIEVE INJECTION
Application Date
Application Number
143504
Application Product Name
BUPRELIEVE INJECTION
Application details
Product name:
BUPRELIEVE INJECTION
Product number:
69057
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of a product registration (Buprelieve Injection) vary the approved shelf life.
Active constituents:
Active constituent name
80831 - BUPRENORPHINE HYDROCHLORIDE
Active constituent name
69057 - BUPRELIEVE INJECTION
Active constituent name
80831 - BUPRENORPHINE HYDROCHLORIDE
Description of data provided:
Data no
269402
Title
PART 2 Chemistry 4a Buprelieve Injection
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
269406
Title
Attachment 2 - Registered Specifications
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
277058
Title
Buprelieve Injection Application 69057_143504 S159 response
Study date
August 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276997
Title
Attachment 8A-1 - Statistical Analysis
Study date
Jan 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276998
Title
Attachment s159-1 - VICH GL51
Study date
Feb 2013
Auth party contact address
-
Data no
269403
Title
PART 2 - Attachment 2-8v2
Study date
January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
269404
Title
PART 2 - Attachment 2-9v2
Study date
November 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
269405
Title
Attachment 1 - DAFF BICON Permit
Study date
16 January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
143281
Product/Active constituent Name
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Application Date
Application Number
143281
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Application details
Product name:
PROMECTIN PLUS LV ALLWORMER PASTE FOR HORSES (300 KG - 600 KG)
Product number:
62378
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to make a minor variation to the registered formulation
Active constituents:
Active constituent name
83910 - PRAZIQUANTEL
Active constituent name
85708 - IVERMECTIN
Description of data provided:
Data no
268863
Title
Attachment 1-4
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268861
Title
Attachment 1-2
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268862
Title
Attachment 1-3
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276140
Title
Attachment 2-3 Draft PV Protocol
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268860
Title
Attachment 1-1
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276144
Title
Attachment 2-1 Raw Material Specification
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276138
Title
Part 2 Chemistry 3
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276139
Title
Attachment 2-2 Routine stability
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276141
Title
Part 8 Efficacy and Safety
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276142
Title
Attachment 8-1 VP extract
Study date
2007
Auth party contact address
-
Data no
276143
Title
Attachment 8-2 Figure 39.8
Study date
2018
Auth party contact address
-
Data no
268864
Title
Attachment 2 - DAFF List
Study date
11 January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268865
Title
Attachment 3 - Extract 1 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268866
Title
Attachment 4 - Extract 2 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
143282
Product/Active constituent Name
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR FOALS AND PONIES (150KG - 300KG)
Application Date
Application Number
143282
Application Product Name
PROMECTIN PLUS LV ALLWORMER PASTE FOR FOALS AND PONIES (150KG - 300KG)
Application details
Product name:
PROMECTIN PLUS LV ALLWORMER PASTE FOR FOALS AND PONIES (150KG - 300KG)
Product number:
64400
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to make a minor variation to the registered formulation
Active constituents:
Active constituent name
83910 - PRAZIQUANTEL
Active constituent name
85708 - IVERMECTIN
Description of data provided:
Data no
268871
Title
Attachment 1-4
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268869
Title
Attachment 1-2
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268870
Title
Attachment 1-3
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268868
Title
Attachment 1-1
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268872
Title
Attachment 2 - DAFF List
Study date
11 January 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268873
Title
Attachment 3 - Excerpt 1 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
268874
Title
Attachment 4 - Excerpt 2 HBoPEv9
Study date
March 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
143492
Product/Active constituent Name
Application Product Name
Spinosad
Application Date
Application Number
143492
Application Product Name
Spinosad
Application details
Product name:
Spinosad
Active name:
Spinosad
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Approval of spinosad for use in agricultural chemical products.
Description of data provided:
Data no
269363
Title
Validation of Analytical Methodology for the Assay of Active Ingredients of Spinosad TC for Solubility and Hydrolysis.
Study date
2016
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269371
Title
Validation of Analytical Methodology for the Assay of Active Ingredients of Spinosad TC.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269372
Title
Spinosad 90%: Validation of the Analytical method for the Determination of the active Ingredient Content.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269373
Title
Spinosad 90%: Validation of the Analytical method for the Determination of the Significant Impurities Content.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269367
Title
Declaration of Composition, Spinosad Technical
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269368
Title
Declaration of Batch Sizes of Spinosad TC in 5 Batch Analysis Report
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269369
Title
Spinosad 90%: Complete Analysis of Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269370
Title
Spinosad 90%: HPLC/MS/DAD Screening for Impurities Content in Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269366
Title
Manufacturing Process of Spinosad Technical.
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269374
Title
Spinosad CoA.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269364
Title
Chemical and Physical Characterization of Spinosad TC: Color, Physical State, Odor, Melting Point, Partition Coefficient, Solubility and Active Ingredient Content.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269365
Title
Chemical and Physical Characterization of Spinosad TC: pH, Density, Explodability, Dissociation Constant, Corrosiveness to Packaging Materia, Hydrolysis Rate, Surface Tension and Corrosion Characteristics to Metal.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269360
Title
Spinosad 90%: Spectroscopic Characterization of Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269361
Title
Final Report Spinosad 90%: Spectroscopic Characterization of Five Batch Samples.
Study date
2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269362
Title
Determination of the Vapour Pressure of Spinosad TC according to OECD 104 resp. EU A.4 using the effusion method: Knudsen Cell.
Study date
2020
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269359
Title
DC17-39423393- ITEM 17, CHEMISTRY 3 SPINOSAD TGAC ??? NEW SOURCE
Study date
27 March 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia