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

143307
Product/Active constituent Name

Application Product Name

Kenso Agcare Pendi 455 CS Herbicide

Application details

Product name:

Kenso Agcare Pendi 455 CS Herbicide

Product number:

94719

Applicant Name:

KENSO CORPORATION (M) SDN. BHD.

Application purpose and description of use:

Registration of 455 g/L pendimethalin, capsule suspension product for the control of wireweed, annual grasses (including annual ryegrass) and certain broadleaf weeds in various crops

Reference details:

80856 - Fist HydroCap Herbicide

Active constituents:

Active constituent name
83462 - Pendimethalin

Description of data provided:

Data no
268932
Author
Kenso Corporation (M) Sdn Bhd
Title
2.1 COA of Active Ingredient
Study date
09/04/22
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268935
Author
Kenso Corporation (M) Sdn Bhd
Title
2.4 Analytical method and validation Pendi 455 CA
Study date
13/10/22
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268933
Author
Kenso Corporation (M) Sdn Bhd
Title
2.2 SDSs of Inert Ingredient
Study date
March 2024
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268931
Author
Kenso Corporation (M) Sdn Bhd
Title
2.0 Chemistry and Manufacture Pendi 455 CS
Study date
05/02/24
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
280900
Author
Kenso Corporation (M) Sdn Bhd
Title
2.3 Revised Stability Report Pendi 455 CS
Study date
13/10/22
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268934
Author
Kenso Corporation (M) Sdn Bhd
Title
2.3 Stability report Pendi 455 CS
Study date
March 2024
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268936
Author
Kenso Corporation (M) Sdn Bhd
Title
Part 8 Efficacy and Crop Safety Pendi 455 CS
Study date
09/02/24
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268937
Author
OptiAg
Title
The efficacy of Kenso Pendimethalin at controlling annual ryegrass and wire weed in a wheat crop
Study date
11/03/2022
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268938
Author
Kalyx
Title
Efficacy and safety of Kenso Pendimethalin in brassica crops
Study date
11/03/22
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268939
Author
Agreco
Title
Bioequivalence of Kenso Pendimethalin 455 with UPL Fist Hydrocap for control of weeds in maize
Study date
11/03/2022
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
268940
Author
Kalyx
Title
Bioequivalence and crop safety of Kenso Pendimethalin with UPL Fist Hydrocap for weed control in tree crops
Study date
22/09/23
Authorising party
Applicant
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Date

Application Date

Application No

Application Number

143191
Product/Active constituent Name

Application Product Name

SLEEP-EASY MOSQUITO & FLY CONTROL PLUG-IN UNIT

Application details

Product name:

SLEEP-EASY MOSQUITO & FLY CONTROL PLUG-IN UNIT

Product number:

94693

Applicant Name:

Lifeguard Sciences (Pty) Ltd

Application purpose and description of use:

Registration of a 6.8g/L Transfluthrin Liquid Emanator Device for the control of mosquitoes for up to 30 nights used 10 hours per night.

Reference details:

64992 - MORTEIN MOZZIE ZAPPER MOSQUITO & FLY CONTROL

Active constituents:

Active constituent name
47544 - TRANSFLUTHRIN

Description of data provided:

Data no
280120
Author
Environmental Science
Title
Certificate of analysis-transfluthrin
Study date
29 February 2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
285577
Author
Beth Patterson
Title
Confirmation of manufacturing site for the Active Ingredient Transfluthrin TC
Study date
14.04.2025
Authorising party
2022 Environmental Science AU Pty Ltd
Auth party contact address
Active ingredient manufacturer
Data no
285578
Author
SA Felt convertors
Title
Packing Document 04 Sleepeasy Mosquito and Fly Control
Study date
02.04.2025
Authorising party
SA Felt Convertors
Auth party contact address
Product Manufacturer
Data no
285579
Author
SA Felt Convertors
Title
SLEEPEASY MOZ AND FLY L.E.D WEIGHT REPORT
Study date
01.12.2022
Authorising party
SA Felt Convertors
Auth party contact address
Product Manufacturer
Data no
280121
Author
Lifeguard Sciences Pty Ltd
Title
SLEEP-EASY MOSQUITO AND FLY CONTROL PLUG-IN UNIT FORMULATION
Study date
15 October 2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
285580
Author
Bayer AG
Title
Safety Data Sheet_Transfluthrin TC
Study date
02.10.2019
Authorising party
Public
Auth party contact address
-
Data no
285581
Author
Sigma Aldrich
Title
Safety Data Sheet_Butylated hydroxytoluene
Study date
12.04.2023
Authorising party
Public
Auth party contact address
-
Data no
285582
Author
Sigma Aldrich
Title
Safety Data Sheet_Butyl stearate
Study date
06.09.2022
Authorising party
Public
Auth party contact address
-
Data no
285583
Author
Sigma Aldrich
Title
Safety Data Sheet_Tri (propylene glycol) methyl ether, mixture of Isomers
Study date
14.08.2023
Authorising party
Public
Auth party contact address
-
Data no
285584
Author
SA Felt Convertors
Title
Process Flow Diagram_Sleepeasy Mosquito and Fly Control Plug-In Unit
Study date
03.02.2025
Authorising party
SA felt Convertors
Auth party contact address
Product Manufacturer
Data no
268697
Author
Mike Van Schoor
Title
Letter of manufacture
Study date
10 November 2023
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268699
Author
Lifeguard Sciences (Pty) Ltd
Title
SLEEP-EASY MOSQUITO & FLY CONTROL PLUG-IN UNIT packaging informatio
Study date
2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268703
Author
Endura S.p.A
Title
Endura TFT Safety Data Sheet
Study date
20/08/2018
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
285585
Author
SA felt convertors
Title
Product packaging specification
Study date
25/04/2025
Authorising party
SA Felt Convertors
Auth party contact address
Product Manufacturer
Data no
285586
Author
Manuela Corazza
Title
Letter of Access to data on stability studies of a Liquid Emanator Device
Study date
11.04.2025
Authorising party
Endura
Auth party contact address
Supplier
Data no
268698
Author
Manuela Corazza
Title
Letter of access to data on stability studies of a liquid emanator device
Study date
29 January 2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268704
Author
Jan van Schoor
Title
A study to test the efficacy of DEADFAST SLEEP EASY (electric liquid dispenser) for the control of mosquitoes (Culicidae - Culex sp.)
Study date
13 December 2019
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268705
Author
C Linn
Title
Insecticidal efficacy of a Liquid Emanator Device Product against House Mosquitoes, Culex quinquefasciatus and Asian tiger mosquitoes
Study date
14/12/2017
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280117
Author
Lifeguard Sciences Pty Ltd
Title
EFFICACY AND SAFETY OVERVIEW:94693/143191 SLEEP-EASY MOSQUITO AND FLY CONTROL PLUG-IN UNIT
Study date
15 October 2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280118
Author
Lifeguard Sciences Pty Ltd
Title
JUSTIFICATION FOR THE PROPOSED CLAIMS OF FLIES ON THE SLEEP-EASY MOSQUITO & FLY CONTROL PLUG-IN UNIT LABEL
Study date
15 October 2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280119
Author
Lifeguard Sciences Pty Ltd
Title
RESPONSE TO SECTION 159 (1)(a) NOTICE: 94693/143191 SLEEP-EASY MOSQUITO AND FLY CONTROL PLUG-IN UNIT
Study date
15 October 2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268706
Author
ZOBELE
Title
SLEEP-EASY MOSQUITO & FLY CONTROL PLUG-IN UNIT ??? PACKAGING INFORMATION
Study date
2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268707
Author
Firefinch Holdings
Title
Deadfast Sleep-easy
Study date
2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268700
Author
Department of agriculture, land reform and rural development-SA
Title
Certificate of registration:Agricultural remedy
Study date
2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
285587
Author
Lifeguard sciences
Title
RESPONSE TO SECTION 159 (1)(a) NOTICE: 94693/143191 SLEEP-EASY MOSQUITO AND FLY CONTROL PLUG-IN UNIT
Study date
07/04/2025
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
285740
Author
Endura
Title
ENDURLED TFT Australia LoA Wefco validation studies 20250411
Study date
11/04/2025
Authorising party
Anon
Data no
285741
Author
Anon
Title
Mo5977 MV179 Transfluthrin in LED validation final report
Study date
22/08/2028
Authorising party
Anon
Data no
268702
Author
Lifeguard Sciences Pty Ltd
Title
SleepEasy LED Lifeguard WHS_AUS
Study date
2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
268701
Author
Lifeguard Sciences
Title
TOXICOLOGY REPORT FOR SLEEP-EASY MOSQUITO & FLY CONTROL PLUG-IN UNIT
Study date
2024
Authorising party
Applicant
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Date

Application Date

Application No

Application Number

143616
Product/Active constituent Name

Application Product Name

SELECT XTRA HERBICIDE

Application details

Product name:

SELECT XTRA HERBICIDE

Product number:

65513

Applicant Name:

ARYSTA LIFESCIENCE NORTH AMERICA LLC

Application purpose and description of use:

Variation of product registration and label approval to include control of grass weeds in fodder beet and forage brassica for animal feed.

Active constituents:

Active constituent name
51099 - CLETHODIM

Description of data provided:

Data no
270211
Author
Anon.
Title
Part 8: Efficacy and Safety Dossier
Study date
2024
Authorising party
Applicant
Data no
270203
Author
Anon.
Title
Letter of Consent
Study date
2023
Authorising party
Dairy Australia Limited
Auth party contact address
Level 3, HWT Tower, 40 City Road, Southbank, Vic, 3006
Data no
270202
Author
Anon.
Title
Centurion Xtra Herbicide - New Zealand label
Study date
2024
Authorising party
Applicant
Data no
270207
Author
Weissenburger, B., Kruplak, JF., Wilkes, LC.
Title
COW FEEDING STUDY: DETERMINATION OF RESIDUES OF CLETHODIM IN BOVINE TISSUES AND MILK
Study date
1989
Authorising party
Applicant
Data no
270208
Author
Fletcher, DW., Pedersen, CA.
Title
CLETHODIM (5%) & CLETHODIM SULFOXIDE (95%): MEAT AND EGG RESIDUE STUDY IN WHITE LEGHORN CHICKENS
Study date
1988
Authorising party
Applicant
Data no
270209
Author
Brielbeck, B., Marx, D.
Title
RESIDUE ANALYSIS OF CLETHODIM IN SUGAR BEETS
Study date
1996
Authorising party
Applicant
Data no
270210
Author
Etter, GE.
Title
CLETHODIM RESIDUES IN OILSEED RAPE, SUGAR AND FODDER BEETS RESIDUE TRIALS IN FRANCE
Study date
1988
Authorising party
Applicant
Data no
270205
Author
Pannu, A
Title
DETERMINATION OF CLETHODIM RESIDUES IN FODDER BEET FOLLOWING THE POST EMERGENCE APPLICATION OF SELECT XTRA
Study date
2020
Authorising party
Dairy Australia Limited
Auth party contact address
Level 3, HWT Tower, 40 City Road, Southbank, Vic, 3006
Data no
270206
Author
Collett, M
Title
DETERMINATION OF CLETHODIM RESIDUES IN FORAGE BRASSICAS
Study date
2021
Authorising party
Dairy Australia Limited
Auth party contact address
Level 3, HWT Tower, 40 City Road, Southbank, Vic, 3006
Data no
270204
Author
Anon.
Title
Part 5: Residues Dossier
Study date
2024
Authorising party
Applicant
Date

Application Date

Application No

Application Number

143634
Product/Active constituent Name

Application Product Name

PYRASULFOTOLE

Application details

Product name:

PYRASULFOTOLE

Active name:

PYRASULFOTOLE

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Approval of a new source of Pyrasulfotole technical for use in agricultural chemical products.

Description of data provided:

Data no
270238
Author
Yarnton, A
Title
Method Validation for the determination of Pyrasulfotole in a technical material (TC)
Study date
23-Jun-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
270240
Author
Yarnton, A
Title
Method Validation for the determination of cyanide in pyrasulfotole technical material (TC)
Study date
21-Nov-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
270237
Author
Yarnton, A
Title
5-Batch Analysis Report
Study date
21-Dec-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
270235
Author
Song Li
Title
Manufacturing process of pyrasulfotole technical
Study date
11-Apr-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
270236
Author
Yarnton, A
Title
Declaration of composition
Study date
21-Dec-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
270239
Author
Yarnton, A
Title
Impurity profile of Pyrasulfotole technical material (TC)
Study date
21-Dec-2023
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
281564
Author
Nutrien Ag Solutions Limited
Title
APP-2-1_Manufacturing process of pyrasulfotole technical_2024-11-28
Study date
Nov-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
281565
Author
Nutrien Ag Solutions Limited
Title
APP-2-3_5-batch analysis_2024-11-28
Study date
Nov-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
281566
Author
Nutrien Ag Solutions Limited
Title
APP-2-2_Declaration of composition_2024-11-28
Study date
Nov-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
281563
Author
Nutrien Ag Solutions Limited
Title
Response to Section 159(1)(a) notice for application 94779-143634
Study date
Dec-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
270234
Author
Miller S
Title
Part 2 Chemistry and Manufacture, Pyrasulfotole technical
Study date
11-Apr-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

143501
Product/Active constituent Name

Application Product Name

DUPLOCILLIN PROCAINE AND BENZATHINE PENICILLIN INJECTION

Application details

Product name:

DUPLOCILLIN PROCAINE AND BENZATHINE PENICILLIN INJECTION

Product number:

37266

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of product registration and label approval with regard to formulation, in-process testing and storage stability.

Active constituents:

Active constituent name
54748 - BENZATHINE PENICILLIN
Active constituent name
56227 - PROCAINE PENICILLIN
Active constituent name
84121 - BENZYLPENICILLIN BENZATHINE
Active constituent name
85730 - BENZYLPENICILLIN PROCAINE
Active constituent name
85730 - BENZYLPENICILLIN PROCAINE

Description of data provided:

Data no
269395
Author
MSD Animal Health
Title
CoA BN 22DU027/1
Study date
February 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269396
Author
MSD Animal Health
Title
CoA BN 23DU001/1
Study date
June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269397
Author
MSD Animal Health
Title
CoA BN 23DU008/1
Study date
November 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269388
Author
MSD Animal Health
Title
DUP-INT_VAR_Composition Change Variation summary
Study date
Feb 2006
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269389
Author
MSD Animal Health
Title
Formulation overview Duplocillin
Study date
March 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269401
Author
MSD Animal Health
Title
Finished product specifications
Study date
2004
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
283172
Author
Intervet Australia Pty Limited
Title
Applicant response s159(1)(a) 20 December 2024
Study date
20 December 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
284856
Author
Eudra- Anonymous (public domain)
Title
Certificate of GMP compliance of a manufacturer - NBF/40/2024V
Study date
11 Sep 2024
Authorising party
Public
Auth party contact address
-
Data no
269394
Author
MSD Animal Health
Title
EU Minor variation change description
Study date
March 2011
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269398
Author
P. Salomons
Title
GMP Site NL exp.31Aug2026.
Study date
22 January 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269399
Author
Anonymous
Title
GMP Site IT exp.17Feb2025.
Study date
4 April 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269390
Author
MSD Animal Health
Title
RTQ for application 37266/55524.
Study date
March 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269391
Author
MSD Animal Health
Title
2010 Stability batch results to 36 months.
Study date
July 2013
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269392
Author
MSD Animal Health
Title
2019 Stability batch results to 36 months.
Study date
September 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269387
Author
MSD Animal Health
Title
Notice on Application with reasons 37266/55524_s14(2).
Study date
18 June 2012
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269400
Author
MSD Animal Health
Title
Manufacturers Declaration template- No Import Permit required.
Study date
March 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269386
Author
MSD Animal Health
Title
Cover letter for application
Study date
March 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
269393
Author
MSD Animal Health
Title
Residues evaluation for Item 14.
Study date
March 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date

Application Date

Application No

Application Number

141453
Product/Active constituent Name

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
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Five Batches Analysis of Azoxystrobin TC
Study date
January 11, 2016
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259335
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
DoC of Azoxystrobin TC
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259336
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Manufacture Process of Azoxystrobin Technical
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259339
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
The Justification of Impurities of Azoxystrobin Technical
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259340
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
The statement of batch size of Azoxystrobin technical in 5-batch report
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
271307
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Test QC results of Azoxystrobin in the random samples produced in January 2022 to May 2023
Study date
April 19, 2024
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259337
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Physical and chemical properties of Azoxystrobin
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
259338
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Registration Data of Azoxystrobin
Study date
July 5, 2023
Authorising party
Applicant
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 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
Author
United States Pharmacoepoieal Commission
Title
<2> Oral Drug Products ? Product Quality Tests
Study date
June 2024
Authorising party
Public
Auth party contact address
-
Data no
273859
Author
United States Pharmacopoeial Commission
Title
<905> Uniformity of Dosage Units
Study date
June 2024
Authorising party
Public
Auth party contact address
-
Data no
273860
Author
United States Pharmacopoeial Commission
Title
<698> Deliverable Volume
Study date
June 2024
Authorising party
Public
Auth party contact address
-
Data no
268857
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Specification
Study date
March 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
268858
Author
Austrian Federal Office for Safety in Healthcare
Title
Certificate of GMP Compliance of a Manufacturer
Study date
20 January 2023
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
273857
Author
Dechra
Title
Response to s159(1)(a) notice of requirement of information, report or sample
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
273861
Author
J Teale
Title
Permit to import conditionally non-prohibited goods
Study date
16 May 2022
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
273862
Author
Department of Agriculture, Fisheries and Forestry
Title
List of Approved Ingredients for Retail Packaged Veterinary Therapeutics and Cosmetics for Animals
Study date
8 February 2023
Authorising party
Public
Auth party contact address
-
Data no
277375
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Permit Application: 0009272784
Study date
5 August 2024
Authorising party
Applicant
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
277376
Author
Department of Agriculture, Fisheries and Forestry
Title
Tax Invoice / Receipt
Study date
5 August 2024
Authorising party
Applicant
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 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
Author
Wu. E,
Title
Mesotrione Technical (ZA1296) - Analytical Method SA-63/1
Study date
13 November 2012
Data no
270199
Author
Wu. E, Emborsky. P, Thompson. J and Zhang. Y,
Title
Determination of Impurities in Mesotrione Manufacturing Use Product (ZA1296) - Analytical Method AK-225/3
Study date
18 March 2013
Data no
270196
Author
Zhang. Y,
Title
Mesotrione Technical (ZA1296) ??? Analysis of Five Representative Batches
Study date
04 April 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270197
Author
Zhang. Y,
Title
Analysis of Dimethylformamide in five Representative Batches
Study date
30 March 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270194
Author
Grosenick. H,
Title
Manufacturing Process Mesotrione
Study date
31 December 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270195
Author
Nayyar, P.
Title
Declaration of Composition
Study date
14 March 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270192
Author
Nayyar, P.
Title
Part 2 - Chemistry and Manufacture
Study date
01 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270193
Author
Zhang. Y,
Title
Statement on UV wavelength screening of Mesotrione (ZA1296) by Diode array
Study date
04 April 2023
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
270200
Author
Zhang Y,
Title
Mesotrione (ZA1296) ??? Validation of analytical method SA-63/1
Study date
19 November 2013
Data no
270201
Author
Zhang Y,
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 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
Author
Elena Rigamonti
Title
Pymetrozine Technical: Complete Analysis of Five Batch Samples
Study date
11/10/2022
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270028
Author
Anon
Title
Doc
Study date
25/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270029
Author
anon
Title
The Statement of Batch Size of Gibberellic acid Technical in 5-Batch Report
Study date
25/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270026
Author
Anon
Title
MANUFACTURE PROCESS OF Pymetrozine TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270024
Author
Yasser Sokeirik
Title
Chemistry &Manufacturing Dossier
Study date
08/04/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
270027
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF Pymetrozine TECHNICAL
Study date
2024
Authorising party
Applicant
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 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
Author
L Ye
Title
Pyroxosulfone - CoA
Study date
1 June 2023
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270030
Author
Agro-Allaince (Australia) Pty Ltd
Title
Part 2 - C&M - A-E proxafone 500 SC Herbicide
Study date
March 2024
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270033
Author
Various
Title
Excipient - SDSs
Study date
2024
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270031
Author
K Ayyavoo
Title
Accelerated Storage Stability Study of Pyroxasulfone 500 g/L SC
Study date
21 February 2023
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270034
Author
L Ye
Title
Evaluate of Agro-Essence Proxafone 500 SC Herbicide for the control of Annual Ryegrass (Lolium rigidum) in Wheat
Study date
2 February 2024
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
270035
Author
L Ye
Title
Evaluate of Agro-Essence Proxafone 500 SC Herbicide for the control of Annual Ryegrass (Lolium rigidum) in Wheat
Study date
20 January 2024
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
276742
Author
L. Ye
Title
Evaluate of Agro-Essence Proxafone 500 SC Herbicide for the control of Annual Ryegrass (Lolium rigidum) in lupins
Study date
7/8/2024
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
276743
Author
Agro-Alliance Australia Pty Ltd
Title
PART 8 - EFFICACY AND SAFETY
Study date
09/08/2024
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date

Application Date

Application No

Application Number

143581
Product/Active constituent Name

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
Author
Stephen Chen
Title
Study Title: Five Batch Analysis of Spiroxamine Technical
Study date
14/10/2021
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269978
Author
Anon
Title
Doc
Study date
20/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269979
Author
anon
Title
2 5 The Statement of Batch Size of Spiroxamine Technical in 5-Batch Report
Study date
20/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269980
Author
Anon
Title
CoA
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269976
Author
Anon
Title
MANUFACTURE PROCESS OF TRIBENURON-METHYL TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269974
Author
Shandong Rainbow International Co., Ltd.
Title
Chemistry &Manufacturing Dossier
Study date
14/12/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269977
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF TRIBENURON-METHYL TECHNICAL
Study date
2024
Authorising party
Applicant
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 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
Author
ANIL V.
Title
FIVE BATCH ANALYSIS OF CHLORMEQUAT CHLORIDE TECHNICAL-Non confidential Attachment
Study date
29/06/2022
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269989
Author
ANIL V.
Title
FIVE BATCH ANALYSIS OF CHLORMEQUAT CHLORIDE TECHNICAL- confidential Attachment
Study date
29/06/2022
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269992
Author
Anon
Title
Doc
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269993
Author
anon
Title
The Statement of Batch Size of Gibberellic acid Technical in 5-Batch Report
Study date
25/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269990
Author
Anon
Title
MANUFACTURE PROCESS OF CHLORMEQUAT CHLORIDE TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269987
Author
Shandong Rainbow International Co., Ltd.
Title
Chemistry &Manufacturing Dossier
Study date
08/04/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269991
Author
Anon
Title
THE JUSTIFICATION OF IMPURITIES OF CHLORMEQUAT CHLORIDE TECHNICAL
Study date
2024
Authorising party
Applicant
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

143083
Product/Active constituent Name

Application Product Name

MAC Slay with natural pyrethrins

Application details

Product name:

MAC Slay with natural pyrethrins

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
Author
MGK
Title
Certificate of Analysis - Piperonyl Butoxide
Study date
21/12/2022
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268410
Author
Botanical Resources Australia
Title
Certificate of Analysis - Pale Refined Pyrethrins
Study date
21/05/2020
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268411
Author
Sumitomo Chemical Australia
Title
Batch Analysis Resutls - Pale refined pyrethrins
Study date
13/11/2020
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268412
Author
Sumitomo Chemical Australia
Title
Batch Analysis Results - Piperonyl butoxide
Study date
17/10/2023
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268409
Author
Lee Nicholls
Title
Chemistry & Manufacture
Study date
14/12/2023
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268414
Author
SGS
Title
ISO 9001:2015 Certification
Study date
05/01/2021
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268415
Author
SGS
Title
ISO 9001:2015 Certification
Study date
27/09/2023
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268416
Author
Arandee
Title
Product Specification
Study date
18/12/2023
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Data no
268417
Author
Arandee
Title
Quality Control Record
Study date
2024
Authorising party
Applicant
Auth party contact address
108 Rockfield Road Penrose New Zealand
Date

Application Date

Application No

Application Number

143528
Product/Active constituent Name

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
Author
Elena Rigamonti
Title
Fosetyl-aluminium Technical: Complete Analysis of Five Batch Samples
Study date
September 23, 2022
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269876
Author
Anon
Title
Doc
Study date
19/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269877
Author
anon
Title
The Statement of Batch Size of Fosetyl-aluminium Technical in 5-Batch Report
Study date
19/03/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269878
Author
Anon
Title
CoA
Study date
20/01/2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269874
Author
Anon
Title
MANUFACTURE PROCESS OF FOSETYL-ALUMINIUM TECHNICAL
Study date
2024
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269872
Author
Shandong Rainbow International Co., Ltd.
Title
Chemistry &Manufacturing Dossier
Study date
14/12/2023
Authorising party
Applicant
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
269875
Author
Anon
Title
THE JUSTIFICATION OF IMPURITY OF FOSETYL-ALUMINIUM TECHNICAL
Study date
2024
Authorising party
Applicant
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 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
Author
Xie Peijin
Title
Analysis of Active Ingredient and Impurities in Five Batches Bromoxynil Heptanoate TC - Part 1
Study date
5 January 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269883
Author
Xie Peijin
Title
Analysis of Active Ingredient and Impurities in Five Batches Bromoxynil Heptanoate TC - Part 2
Study date
5 January 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269888
Author
C Kelly
Title
Bromoxynil Heptanoate Chemistry 3
Study date
March 2024
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269884
Author
Jiangsu Heben Biochemical Co. Ltd
Title
Bromoxynil Heptanoate Discussion of Formation of Impurities
Study date
April 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269885
Author
Jiangsu Heben Biochemical Co. Ltd
Title
Bromoxynil Heptanoate Manufacturing Process
Study date
April 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269886
Author
Jiangsu Heben Biochemical Co. Ltd
Title
Bromoxynil Heptanoate SDS
Study date
April 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
269887
Author
C Kelly
Title
Bromoxynil Heptanoate Declaration of Composition
Study date
26 March 2024
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date

Application Date

Application No

Application Number

143263
Product/Active constituent Name

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
Author
E Jones
Title
Method Validation Report - Quantification via HPLC-UV
Study date
25.01.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268987
Author
B Pendleton
Title
Supporting chemistry & manufacturing documents
Study date
12.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269003
Author
E Jones
Title
Stability Report
Study date
13.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268990
Author
B Peters
Title
Appendix 4 - Claim Support Justification
Study date
28.10.2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268991
Author
E Jones
Title
Appendix 2 - Certificate of Analysis
Study date
11.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268992
Author
A Pereira
Title
Efficacy Substantiation Report
Study date
06.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268995
Author
A Ahmad
Title
Appendix 3 - Mode of Action Support
Study date
18.01.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268996
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against German Cockroach
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268997
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Trigger Formulations Against a Black Ant
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268998
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against a Brown Ant
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268999
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against House Flies
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269000
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Culex quinquefasciatus Mosquitoes
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269001
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against American Cockroach
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269002
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Aedes aegypti Mosquitoes
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268994
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Pre-application Assistance
Study date
2021
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268988
Author
B Pendleton
Title
Health Module Documents
Study date
19.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
268989
Author
S Sharma
Title
Justification for the claim
Study date
14.03.2024
Authorising party
Applicant
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 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
Author
E Jones
Title
Method Validation Report - Quantification via HPLC-UV
Study date
25.01.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269006
Author
B Pendleton
Title
Supporting Chemistry & Manufacturing Documents
Study date
12.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269004
Author
E Jones
Title
Stability Report
Study date
13.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269009
Author
E Pereira
Title
Efficacy Substantiation Report
Study date
06.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269010
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Trigger Formulations Against a Black Ant
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269011
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against a Brown Ant
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269012
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against American Cockroach
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269013
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against German Cockroach
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269014
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Culex quinquefasciatus Mosquitoes
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269015
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against House Flies
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269016
Author
Insect Research Laboratory
Title
Laboratory Study to Determine the Direct Spray Knockdown & Kill of Two Spray Formulations Against Aedes aegypti Mosquitoes
Study date
16.02.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269017
Author
E Jones
Title
Appendix 2 - Certificate of Analysis
Study date
11.04.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269018
Author
A Ahmad
Title
Appendix 3 - Mode of Action Support
Study date
18.01.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269019
Author
B Peters
Title
Appendix 4 - Claim Support Justification
Study date
28.10.2023
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269020
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Pre-application Assistance
Study date
2021
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269007
Author
B Pendleton
Title
Health module documents
Study date
19.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Data no
269008
Author
S Sharma
Title
Justification for the claim
Study date
14.03.2024
Authorising party
Applicant
Auth party contact address
680 George Street Sydney Australia
Date

Application Date

Application No

Application Number

143500
Product/Active constituent Name

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
Author
Anon
Title
Benazemav 20 - FPS v2
Study date
2024
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269385
Author
Anon
Title
Comparative Table
Study date
2024
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269376
Author
Anon
Title
Benazemav 20 - FPS
Study date
2024
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269377
Author
Anon
Title
2a-qual-quant-partic-proposed
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269378
Author
Anon
Title
2f2-fin-prod
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269379
Author
Anon
Title
Stability Data 1
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269380
Author
Anon
Title
Stability Data 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269381
Author
Anon
Title
Stability Data 3
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269382
Author
Anon
Title
Stability Data 4
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269383
Author
Anon
Title
Stability Commitment
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Data no
269384
Author
Anon
Title
2c3-cont-clos-sys
Study date
2023
Authorising party
Applicant
Auth party contact address
Dublin Road LOUGHREA COUNTY GALWAY Ireland
Date

Application Date

Application No

Application Number

143103
Product/Active constituent Name

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
Author
Unland, F., Wiese, C. & Briskot, G.
Title
Validation of test methods - Residual solvents.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267755
Author
Daferner, M. & Kleban, W.
Title
Validation of test for microbial purity.
Study date
25 May 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267756
Author
Balzer, S., Wiese, C. & Briskot, G.
Title
Validation of test methods - other methods.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267757
Author
Balzer, S., Wiese, C. & Briskot, G.
Title
Method development.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267752
Author
Draksler, M., Balzer, S. & Briskot, G.
Title
Validation of test for assay and impurities.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267786
Author
Wiese, C., Spura, J. & Briskot, G.
Title
Batch analysis for intermediates.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267787
Author
Wiese, C., Spura, J. & Briskot, G.
Title
Batch analysis for intermediates.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267788
Author
Wiese, C., Spura, J. & Briskot, G.
Title
Batch analysis for intermediates.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267758
Author
Wiese, C., Spura, J. & Briskot, G.
Title
Batch analyses.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267759
Author
Weinberg, C., Balzer, S. & Briskot, G.
Title
Batch analyses - development.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267777
Author
Spura, J.
Title
Certificate of analysis.
Study date
20 February 2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267778
Author
Spura, J.
Title
Certificate of analysis.
Study date
20 February 2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267779
Author
Spura, J.
Title
Certificate of analysis.
Study date
20 February 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267735
Author
Selhorst, P., Mayer, M. & Dragut, A.
Title
Control of materials - Starting materials - Batch analyses.
Study date
7 June 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267736
Author
Selhorst, P., Mayer, M. & Dragut, A.
Title
Control of materials - Starting materials - Batch analyses.
Study date
6 June 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267737
Author
Selhorst, P., Mayer, M. & Dragut, A.
Title
Control of materials - Starting materials - Batch analyses.
Study date
6 June 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267738
Author
Renard, U. & Dragut, A.
Title
Quality reference.
Study date
31 March 2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267739
Author
Renard, U. & Reuter, T.
Title
Raw material specification.
Study date
9 May 2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267740
Author
Renard, U. & Dragut, A.
Title
Raw material specification.
Study date
31 March 2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267741
Author
Renard, U. & Dee, K.-H.
Title
Raw material specification.
Study date
2 May 2008
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267742
Author
Spura, J., Selhorst, P. & Wittich, S.
Title
Raw material specification.
Study date
22 December 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267743
Author
Renard, U. & Preuss, B.
Title
Raw material specification.
Study date
9 June 2010
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267744
Author
Nowakowski, M., Geraldy, M. & Pieper, N.
Title
Manufacturing process development.
Study date
8 September 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267713
Author
Grosse-Bley, M., Wiese, C. & Briskot, G.
Title
Manufacturing process - Flow diagram.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267714
Author
Grosse-Bley, M. & Kleban, W.
Title
Manufacturing process - Description.
Study date
5 July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267715
Author
Grosse-Bley, M. & Kleban, W.
Title
Manufacturing process - Description.
Study date
5 July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267716
Author
Grosse-Bley, M. & Kleban, W.
Title
Manufacturing process - Description.
Study date
5 July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267717
Author
Leugers, K. & Briskot, G.
Title
Manufacturing process - Physical treatment.
Study date
22 June 202
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267718
Author
Wiese, C., Grosse-Bley, M. & Briskot, G.
Title
Raw materials.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267719
Author
Renard, U. & Ossadnik, S.
Title
Raw material - specification.
Study date
30 October 2013
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267720
Author
Briskot, G. & Globisch, A.
Title
Raw material - specification.
Study date
7 September 2015
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267721
Author
Briskot, G. & Preuss, B.
Title
Raw material - specification.
Study date
15 February 2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267722
Author
Renard, U. & Globisch, A.
Title
Raw material - specification.
Study date
29 April 2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267723
Author
Renard, U. & Wolbold, R.
Title
Raw material - specification.
Study date
4 December 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267724
Author
Wiese, C. & Li, J.
Title
Raw material - specification.
Study date
15 July 2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267725
Author
Wiese, C. & Kleban, W.
Title
Raw material - specification.
Study date
15 November 2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267726
Author
Wiese, C. & Kleban, W.
Title
Raw material - specification.
Study date
15 November 2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267727
Author
Wiese, C. & Kleban, W.
Title
Raw material - specification.
Study date
12 December 2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267728
Author
Nowakowski, M., Blaas, N. & Pieper, N.
Title
Justification of starting materials.
Study date
8 September 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267729
Author
Nowakowski, M., Wiese, C. & Briskot, G.
Title
Flow chart of the starting material.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267730
Author
Nowakowski, M., Wiese, C. & Briskot, G.
Title
Flow chart of the starting material.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267731
Author
Nowakowski, M., Wiese, C. & Pieper, N.
Title
Flow chart of the starting material.
Study date
6 July 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267732
Author
Wiese, C., Unland, F. & Briskot, G.
Title
Control of materials - starting materials - specification.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267733
Author
Wiese, C., Unland, F. & Briskot, G.
Title
Control of materials - starting materials - specification.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267734
Author
Wiese, C., Unland, F. & Briskot, G.
Title
Control of materials - starting materials - specification.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267781
Author
Nowakowski, M., Blaas, N. & Pieper, N.
Title
Discussion and control of critical steps.
Study date
8 September 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267782
Author
Unland, F., & Wiese, C. & Briskot, G.
Title
List of intermediates.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267783
Author
Wiese, C., Unland, F. & Briskot, G.
Title
Control of intermediates.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267784
Author
Wiese, C., Unland, F. & Briskot, G.
Title
Control of intermediates.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267785
Author
Wiese, C., Spura, J. & Briskot, G.
Title
Control of intermediates.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267780
Author
Anon.
Title
Certificate of Composition.
Study date
1 March 2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267706
Author
Anon.
Title
Quality overall summary on the Pharmaceutical Documentation Module 2.3.S.
Study date
July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267707
Author
Wiese, C. & Briskot, G.
Title
TSE assessment - substance.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267708
Author
Jaenen, S. & Dragut, A.
Title
Labeling of the immediate/shipping container for the bulk drug substance.
Study date
28 June 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267709
Author
Balzer, S. & Briskot, G.
Title
General information - Nomenclature.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267710
Author
Balzer, S. & Briskot, G.
Title
General information - Structure.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267711
Author
Balzer, S., Classen, G. & Briskot, G.
Title
General information - General properties.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267712
Author
Jaenen, S. & Dragut, A.
Title
Manufacturer(s).
Study date
25 September 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267772
Author
Haeniche-Rauhut, C. & Dragut, A.
Title
Specification.
Study date
4 May 2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267773
Author
Haeniche-Rauhut, C. & Dragut, A.
Title
Test procedure.
Study date
4 May 2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267774
Author
Ritz, A. & Pesch, C.
Title
Description of the primary packaging material.
Study date
20 July 2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267775
Author
Lorenzana, G. & Wittich, S.
Title
Release results of several batches.
Study date
20 July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267760
Author
Balzer, S., Wiese, C. & Briskot, G.
Title
Justification of specification.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267761
Author
Wiese, C., Balzer, S. & Briskot, G.
Title
Reference standard.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267762
Author
Spura, J., Unland, F. & Kleban, W.
Title
Reference standards - impurities.
Study date
12 July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267763
Author
Matzeit, A. & Kleban, W.
Title
Packaging materials.
Study date
29 June 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267745
Author
Geraldy, M., Spura, J. & Kleban, W.
Title
Structure elucidation and other characteristics.
Study date
12 July 2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267746
Author
Balzer, S., Wiese, C. & Briskot, G.
Title
Information on polymorphism.
Study date
22 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267747
Author
Nowakowski, M., Balzer, S. & Briskot, G.
Title
Impurities.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267748
Author
Wiese, C., Balzer, S. & Briskot, G.
Title
Impurities - Residual solvents.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267749
Author
Wiese, C., Spura, J. & Briskot, G.
Title
Risk assessment of elemental impurities.
Study date
30 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267750
Author
Mayer, M., Hahn, K. & Pieper, N.
Title
Specification.
Study date
10 October 2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267751
Author
Wiese, C., Unland, F. & Briskot, G.
Title
Test procedure.
Study date
25 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282553
Author
Winkelhake, B., Mayer, M. & Dragut, A.
Title
Molidustat sodium micronized drug substance - risk assessment.
Study date
8 January 2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282554
Author
Jaenen, S. & Dragut, S.
Title
Batch analysis.
Study date
19 December 2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
282555
Author
National Measurement Institute
Title
RE: Molidustat sodium standards_APVMA standard [SEC=OFFICIAL].
Study date
20 January 2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267753
Author
Fleige, M. & Briskot, G.
Title
Validation of test for particle size determination.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267764
Author
Jaenen, S. & Dragut, A.
Title
Stability summary and conclusion.
Study date
1 September 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267765
Author
Jaenen, S. & Dragut, A.
Title
Stability summary and conclusion.
Study date
1 September 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267766
Author
Jaenen, S. & Dragut, A.
Title
Post-approval stability protocol and stability commitment.
Study date
1 September 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267767
Author
Unland, F., Wiese, C. & Briskot, G.
Title
Retest period.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267768
Author
Jaenen, S. & Dragut, A.
Title
Post-approval stability protocol and stability commitment.
Study date
1 September 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267769
Author
Jaenen, S. & Dragut, A.
Title
Stability data.
Study date
11 September 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267770
Author
Belzar, S., Classen, G. & Gernot, B.
Title
Stability data - stress tests.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267771
Author
Classen, G., Balzer, S. & Briskot, G.
Title
Stability data - photostability.
Study date
29 June 2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
267776
Author
Anon.
Title
Safety data Sheet: Molidustat sodium.
Study date
24 January 2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283666
Author
Himmel H
Title
Report 38886 - Oral toxicology
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283667
Author
Hoffmann M
Title
Report 38883 - Oral toxicology
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283668
Author
Beckmann R
Title
Report 38884 - toxicology additional data
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283669
Author
Hucke F, Schwarz T.
Title
Report 44082 - Oral and intravenous toxicology
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283670
Author
Hucke F et al
Title
Report 44084 - Oral toxicology
Study date
2011
Authorising party
Elanco Australasia Pty Ltd
Data no
283671
Author
Hucke F. et al.
Title
Report 44088 - Oral and iv toxicology
Study date
2011
Authorising party
Elanco Australasia Pty Ltd
Data no
283672
Author
Gillissen U
Title
Report 38895 - Acute toxicology oral
Study date
2009
Authorising party
Elanco Australasia Pty Ltd
Data no
283673
Author
Schladt L
Title
Report 38900 - sub-acute oral lab animal
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283674
Author
Himmel H
Title
Report 38889 (D) - Oral toxicology
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283675
Author
Himmel H
Title
Report 38889 (D) - Oral toxicology
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283780
Author
Fraatz, K
Title
Report 46688 - Formulation Oral toxicity
Study date
2019
Authorising party
Elanco Australasia Pty Ltd
Data no
283781
Author
Martin T
Title
Report 46913 - Carcinogenicity study rats
Study date
2019
Authorising party
Elanco Australasia Pty Ltd
Data no
283782
Author
Popp L
Title
Report 46939 - Carcinogenicity study mice
Study date
2018
Authorising party
Elanco Australasia Pty Ltd
Data no
283783
Author
Sternberg J
Title
Report 38907 - Developmental study rabbits
Study date
2015
Authorising party
Elanco Australasia Pty Ltd
Data no
283809
Author
Schmuck G
Title
Report 44312 - Critical evaluation developmental toxicity
Study date
2016
Authorising party
Elanco Australasia Pty Ltd
Data no
283825
Author
Bartels D
Title
Report 38882 - other information
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283659
Author
Steinke W
Title
Report 44092 - Pharmacological distribution data rats
Study date
2015
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
283660
Author
Gerisch M
Title
Report 44098 - Metabolism lab animal
Study date
2016
Authorising party
Elanco Australasia Pty Ltd
Data no
283661
Author
Hucke F
Title
Report PH-40564 - Metabolism lab animals
Study date
2018
Authorising party
Elanco Australasia Pty Ltd
Data no
283662
Author
Radke M
Title
Report 44094 - Metabolism other information
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283664
Author
Gerisch M
Title
Report PH-37906 - Metabolism other animals
Study date
2016
Authorising party
Elanco Australasia Pty Ltd
Data no
283665
Author
Gerisch M
Title
Report 44101 - Metabolism other
Study date
2016
Authorising party
Elanco Australasia Pty Ltd
Data no
283784
Author
Hucke F et al
Title
Report 44083 - Oral and intravenous toxicology
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283785
Author
Lang D
Title
Report 44093 - Toxicology additional information
Study date
2016
Authorising party
Elanco Australasia Pty Ltd
Data no
283786
Author
Lange, C.A.K. et al
Title
Von Hipple- Lindau protwin in the RPE is essential for normal ocular growth and vascular development.
Study date
2012
Data no
283787
Author
Herbold B
Title
Report 38892 - Salmonella/Microsome test
Study date
2009
Authorising party
Elanco Australasia Pty Ltd
Data no
283788
Author
Becker K, Naumann T
Title
Report 38890 - Forward cell mutation
Study date
2009
Authorising party
Elanco Australasia Pty Ltd
Data no
283789
Author
Herbold B
Title
Report 38891 - Micronucleus test - mice
Study date
2007
Authorising party
Elanco Australasia Pty Ltd
Data no
283790
Author
Herbold B
Title
Report 38894 - Cytogenetic study mice
Study date
2011
Authorising party
Elanco Australasia Pty Ltd
Data no
283791
Author
Herbold B
Title
Report 38893 - DNA synthesis rat liver
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283792
Author
Yajima, N. et al
Title
Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietins
Study date
1993
Data no
283793
Author
Tweats D.J et al
Title
Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests: I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazard
Study date
2007
Data no
283794
Author
Himmel H
Title
Report 38885 (D) - toxicology additonal data
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283795
Author
G. Schmuck
Title
42176 - summary user safety
Study date
17 June 2015
Authorising party
Elanco Australasia Pty Ltd
Data no
283796
Author
G. Schmuck
Title
3-2 - Applicant Written Summary (EU) Part 3a Safety
Study date
26 July 2023
Authorising party
Elanco Australasia Pty Ltd
Data no
283797
Author
G.Schmuck
Title
Apx 3-3 - User Safety Risk Assessment
Study date
1 August 2023
Authorising party
Elanco Australasia Pty Ltd
Data no
283798
Author
Schladt L
Title
Report 38896 - Sub-acute oral lab animals
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283799
Author
Ruf J
Title
Report 38888 - Short term study dogs
Study date
2010
Authorising party
Elanco Australasia Pty Ltd
Data no
283800
Author
Schladt L
Title
Report 38902 - sub-chronic oral lab animal
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283801
Author
Schladt L
Title
Report 38901a - Sub-chronic oral lab animals
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283802
Author
Schladt L
Title
Report 38903a - Sub-chronic oral lab animal
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283803
Author
Schladt L
Title
Report 38903b - Sub-chronic oral lab animal
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283804
Author
Ruf J
Title
Report 38897 - Sub-chronic study dogs
Study date
2011
Authorising party
Elanco Australasia Pty Ltd
Data no
283805
Author
Ruf J
Title
Report 38898 - Sub-chronic study dogs
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283806
Author
Ruf J
Title
Report 38904 (D) - Sub-chronic study dogs
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283807
Author
Schladt L
Title
Report 38903c (D) - Sub-chronic oral lab animal
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Data no
283808
Author
Schladt L
Title
Report 38903d (D) - Sub-chronic oral lab animal
Study date
2012
Authorising party
Elanco Australasia Pty Ltd
Date

Application Date

Application No

Application Number

142938
Product/Active constituent Name

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
Author
Not identified
Title
Method of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277259
Author
Not identified
Title
AOAC 2006.03 ICP-OES
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277260
Author
Not identified
Title
AOAC 999.13- Methionine
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277251
Author
Molenaar, F
Title
Batch to Batch - Availa Cr
Study date
3 January 2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277252
Author
Not identified
Title
SAL Chromium CoA_AvCr1000_5 lots
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277253
Author
Not identified
Title
SAL Methionine CoA_AvCr1000_5 lots
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277254
Author
Not identified
Title
CoA_Availa Cr Active Substance_EPL16207A
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277255
Author
Not identified
Title
CoA_Availa Cr Active Substance_EPL 16207C
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277256
Author
Not identified
Title
CoA_Availa Cr Active Substance_EPL 16207D
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277258
Author
Not identified
Title
CoA_Availa Cr Active Substance_EPL 16207E
Study date
2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277243
Author
Heid,V
Title
IFF Availa Cr PSD (partcile size distribution)
Study date
27 June 2016
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277244
Author
Groen,S
Title
Availa Cr 3 PSD & dust
Study date
21 December 2022
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277245
Author
Not identified
Title
Availa Cr 3 - Heavy metals
Study date
27 January 2023
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277246
Author
Not identified
Title
CoA heavy Metals Availa Cr 1000
Study date
13 March 2019
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277247
Author
SGS
Title
ISO Certificate Issue 15 2021-2024
Study date
23 January 2021
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277248
Author
Validus
Title
HACCP Certificate Garner November 22nd 2023
Study date
20 September 2022
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277249
Author
SGS
Title
FAMI-QS Certificate 2020-2023
Study date
1 October 2020
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277335
Author
Wagner,V & VanDyke,S
Title
OECD 471 BioRel_Bacterial Reverse Mutation
Study date
Dec 2008
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277336
Author
Simar,S
Title
OECD 487 CERB_In Vitro micronucleus test_Cr-DL-Meth
Study date
Nov 2016
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277337
Author
Krsmanovia & Huston
Title
OECD 474 BioRel_Mouse bone marrow
Study date
Nov 2008
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277338
Author
Sylwia Terpilowska a, Andrzej Krzysztof Siwicki
Title
Interactions between chromium(III) and iron(III), molybdenum(III) or nickel(II): Cytotoxicity, genotoxicity and mutagenicity studies
Study date
2018
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277339
Author
Martin Figgitt, Roger Newsonb, Ian J. Leslie c, John Fisherc, Eileen Inghamd, Charles P. Casea
Title
The genotoxicity of physiological concentrations of chromium (Cr(III) and Cr(VI)) and cobalt (Co(II)): An in vitro study
Study date
2010
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277340
Author
Naouale El-Yamani a , Liliana Z , Elitsa Stoyanova a , Amadeu Creus & Ricard Marcos
Title
Chromium-Induced Genotoxicity and Interference in Human Lymphoblastoid Cell (TK6) Repair Processes
Study date
2011
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277341
Author
Halina Staniek, Magdalena Kostrzewska-Poczekaj et al
Title
Genotoxicity assessment of chromium(III) propionate complex in the rat model using the comet assay
Study date
2010
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277342
Author
Zhijia Fang, Min Zhao, Hong Zhen, Lifeng Chen, Ping Shi, Zhiwei Huang
Title
Genotoxicity of Tri- and Hexavalent Chromium Compounds In Vivo and Their Modes of Action on DNA Damage In Vitro
Study date
2014
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277343
Author
Nivedita Chatterjee, Zejiao Luo
Title
Cr-(III)-organic compounds treatment causes genotoxicity and changes in DNA and protein level in Saccharomyces cerevisiae
Study date
2010
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia
Data no
277344
Author
Zhanna Sobol and Robert H. Schiestl
Title
Intracellular and Extracellular Factors Influencing Cr(VI) and Cr(III) Genotoxicity
Study date
2012
Authorising party
Applicant
Auth party contact address
13 HIGH STREET LANCEFIELD Australia