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
139970
Product/Active constituent Name
Application Product Name
SALTRO Pro Fungicide Seed Treatment
Application Date
Application Number
139970
Application Product Name
SALTRO Pro Fungicide Seed Treatment
Application details
Product name:
SALTRO Pro Fungicide Seed Treatment
Product number:
93620
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 200 g/L pydiflumetofen, 75 g/L metalaxyl-M and 25 g/L fludioxonil suspension concentrate for seed treatment (FS) product for use in canola.
Reference details:
87705 - SALTRO Fungicide Seed Treatment
53572 - MAXIM XL FUNGICIDE SEED TREATMENT
Active constituents:
Active constituent name
82485 - PYDIFLUMETOFEN
Active constituent name
44550 - METALAXYL-M
Active constituent name
60841 - FLUDIOXONIL
Active constituent name
65515 - FLUDIOXONIL
Description of data provided:
Data no
253933
Title
A24003A - Chemical Characterization of Batch ELN001-009-003
Study date
16 June 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253935
Title
A24003A- ST-75/1- Determination of CGA173506, CGA329351, SYN545974 in A24003A by HPLC
Study date
06 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253936
Title
Analytical Method STA-75/1 - Determination of CGA329351 and CGA351920, in A24003A by chiral HPLC
Study date
06 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253937
Title
A24003A ??? Validation of Analytical Method ST-75/1
Study date
03 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253938
Title
A24003A ??? Validation of Analytical Method STA-75/1
Study date
03 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272315
Title
A24003A - Physical and Technical Properties of Batch ELN001-009-003
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272316
Title
A22657B - Physical and Technical Properties of Batch SGBW180118-GLP1
Study date
2018
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272317
Title
A9638A - Technical Properties on treated seed of batch SSP9B014
Study date
2011
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253927
Title
Part 2 - Chemistry and Manufacture
Study date
12 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253928
Title
Safety Data Sheets
Study date
06 April 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253929
Title
Certificates of Analysis - Active Constituents
Study date
13 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253930
Title
A24003A ??? Physical and Technical Properties of Batch ELN001-009-003
Study date
13 October 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253931
Title
A24003A ??? Physico- chemical Properties of Batch ELN001-009-003
Study date
13 October 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253932
Title
A24003A - Safety Study
Study date
09 June 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253934
Title
A24003A - Storage Stability and Shelf Life Statement (2 Weeks 54 ??C and 4 Weeks 54 ??C) in Packaging Made of HDPE according to CIPAC MT 46.4
Study date
20 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253962
Title
Evaluation of a fungicide in canola. Major Plains, Victoria. 2022.
Study date
30 December 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253963
Title
Evaluation of a fungicide in canola. Laharum, Victoria, 2022.
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253964
Title
Evaluation of a fungicide for disease control in canola. Forthside, Tasmania, 2021.
Study date
17 November 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253965
Title
Evaluation of a fungicide in canola. Moriarty, Tasmania, 2022-2023.
Study date
22 February 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253966
Title
Evaluation of a fungicide in canola. Forthside, Tasmania, 2021.
Study date
17 November 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253967
Title
Evaluation of a fungicide in canola. Forthside, Tasmania, 2021.
Study date
08 February 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253954
Title
Part 8 - Efficacy and Crop Safety
Study date
16 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253955
Title
Evaluation of a fungicide in canola. Tuppal, New South Wales. 2021.
Study date
21 October 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253956
Title
Evaluation of a fungicide in canola. BoyupBrook, Western Australia. 2021.
Study date
26 August 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253957
Title
Evaluation of a fungicide in canola. Australia. 2021.
Study date
October 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253958
Title
Evaluation of a fungicide in canola. Australia. 2022.
Study date
December 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253959
Title
Evaluation of a fungicide in canola. Monjebup, Western Australia. 2022.
Study date
04 August 2022.
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253960
Title
Evaluation of a fungicide in canola. Barooga, New South Wales. 2022.
Study date
14 December 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272318
Title
Evaluation of a fungicide in canola. Tuppal, New South Wales. 2021. Amended.
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272319
Title
Evaluation of a fungicide in canola. BoyupBrook, Western Australia. 2021. Amended.
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272320
Title
Evaluation of a fungicide in canola. Australia. 2021. Amended.
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272321
Title
Evaluation of a fungicide in canola. Australia. 2021 - Raw data Trials 1-2. Amended.
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272322
Title
Evaluation of a fungicide in canola. Australia. 2021 - Raw data Yield trial 1-9. Amended.
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272323
Title
Evaluation of a fungicide in canola. Australia. 2022. Amended.
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272324
Title
Evaluation of a fungicide in canola. Australia. 2021 - Raw data. Trial 1-2. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272325
Title
Evaluation of a fungicide in canola. Australia. 2021 - Raw data. Yield trials 1-9. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272326
Title
Evaluation of a fungicide in canola. Monjebup, Western Australia. 2022. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272327
Title
Evaluation of a fungicide in canola. Barooga, New South Wales. 2022. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272328
Title
Evaluation of a fungicide in canola. Boyup Brook, Western Australia. 2022. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272329
Title
Evaluation of a fungicide in canola. Major Plains, Victoria. 2022. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272330
Title
Evaluation of a fungicide in canola. Laharum, Victoria, 2022. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272331
Title
Evaluation of a fungicide in canola. Laharum, Victoria, 2022 - Raw data. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272332
Title
Evaluation of a fungicide in canola. Moriarty, Tasmania, 2022-2023. Amended
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272333
Title
Pydiflumetofen: An SDHI seed-applied fungicide, a potential tool for the canola-blackleg management toolbox.
Study date
2022
Auth party contact address
-
Data no
272334
Title
Saltro Pro Part 8 (updated)
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253961
Title
Evaluation of a fungicide in canola. Boyup Brook, Western Australia. 2022.
Study date
14 September 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272335
Title
Saltro Pro draft label (highlighted changes)
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
272336
Title
Response to APVMA s.159 notice
Study date
2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253952
Title
Determination of metalaxyl-M residues in canola forage, seed and stubble following the seed applied application of A-24003-A. Australia, 2022-2023
Study date
11 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253953
Title
Part 5B ??? Trade Aspects of Residues in Food Commodities
Study date
16 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253951
Title
Part 5A - Residues
Study date
16 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253941
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ??? Acute Dermal Toxicity Study in Rats
Study date
23 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253945
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ??? In Vitro Eye Irritation Test in Isolated Chicken Eyes
Study date
02 September 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253946
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ??? Acute Eye Irritation Study in Rabbits
Study date
09 September 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253942
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) - Acute Inhalation Toxicity Study (Nose-Only) in Rats
Study date
28 October 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253940
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ??? Acute Oral Toxicity Study in Rats (Up and Down Procedure)
Study date
29 August 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253943
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ??? In Vitro Skin Irritation Test in the EPISKIN??? Model
Study date
02 September 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253944
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ???Primary Skin Irritation Study in Rabbits
Study date
12 September 2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253947
Title
Pydiflumetofen/Fludioxonil/Metalaxyl-M FS (A24003A) ??? Skin Sensitization Test (Local Lymph Node Assay)
Study date
27 January 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253948
Title
Toxicological Database - Pydiflumetofen
Study date
01 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253949
Title
Toxicological Database - Fludioxonil
Study date
01 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253950
Title
Toxicological Database - Metalaxyl-M
Study date
02 March 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
253939
Title
Part 3 - Toxicology
Study date
03 April 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
140104
Product/Active constituent Name
Application Product Name
IMTRADE MAXILLA 850 WG INSECTICIDE & MITICIDE
Application Date
Application Number
140104
Application Product Name
IMTRADE MAXILLA 850 WG INSECTICIDE & MITICIDE
Application details
Product name:
IMTRADE MAXILLA 850 WG INSECTICIDE & MITICIDE
Product number:
93662
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 850g/kg Chlorfenapyr water dispersible granule product for the control of Cabbage White Butterfly and Diamondback Moth in Brassica Vegetables, Two-spotted Mite in Apples, Peaches and Pears and Bollworm, Native Budworm and Two-spotted Mite in Cotton as per the Directions for Use table.
Reference details:
47738 - INTREPID 360 SC INSECTICIDE-MITICIDE
49112 - SECURE 360 SC INSECTICIDE-MITICIDE
Active constituents:
Active constituent name
90259 - CHLORFENAPYR
Description of data provided:
Data no
254357
Title
CoA Chlorfenapyr Technical
Study date
19/08/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254355
Title
Imtrade Chlorfenapyr 850 WG Method Validation ??? Feb 2022
Study date
02/02/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254354
Title
Imtrade Chlorfenapyr 850 WG 1 Batch Analysis ??? Feb 2022
Study date
02/02/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254353
Title
Formulation & Stability Report - Imtrade Chlorfenapyr 850 WG Insecticide & Miticide
Study date
24/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254356
Title
Safety Data Sheets for other Constituents
Study date
31/05/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254358
Title
Argument to satisfy AgVet Chemicals Code Act 1994 (Cth) s.14(3) in countering the commercial in confidence aspects of the reference product???s non-protected data
Study date
27/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254352
Title
Method of Manufacture (inc. Quality Controls) - Imtrade Chlorfenapyr 850 WG Insecticide & Miticide
Study date
24/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254360
Title
Investigation into the Bio-efficacy of IMTRADE MAXILLA?? 850 WG INSECTICIDE & MITICIDE compared to OMITE 570EW LIQUID MITICIDE for the control of Two Spotted Mite in Apples cv. Gala (Malus domestica ???Gala???) ??? One Trial, Forest Range, South Australia.
Study date
02/05/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254361
Title
Investigation of the Bio-efficacy of IMTRADE MAXILLA?? 850 WG INSECTICIDE & MITICIDE for the control of Cabbage White Butterfly on Brussel Sprouts cv. Divino (Brassica oleracea var. gemmifera) ??? One Trial, Langhorne Creek, South Australia.
Study date
22/02/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254362
Title
Investigation of the Bio-efficacy of IMTRADE MAXILLA?? 850 WG INSECTICIDE & MITICIDE compared to OMITE 570EW LIQUID MITICIDE for the control of Two Spotted Mite in a commercial Peach cv. ???August Flame??? orchard ??? One Trial, Roleystone, Western Australia.
Study date
24/04/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254363
Title
Investigation into the Bio-efficacy of IMTRADE MAXILLA?? 850 WG INSECTICIDE & MITICIDE compared to IMTRADE BIFENTRHIN ULTRA 300 EC INSECTICIDE for the control of Lepidopteran Pests in Cotton cv. Sicot 711RRF ??? One Trial, Forest Hill, Queensland.
Study date
28/02/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254364
Title
Comments to Support Host Crop Safety and Efficacy Data submitted.
Study date
26/05/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
254359
Title
OH&S Report - Imtrade MAXILLA?? 850 WG Insecticide & Miticide
Study date
31/05/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
139781
Product/Active constituent Name
Application Product Name
Ratsak 25 Waxblocks Kills Rats & Mice
Application Date
Application Number
139781
Application Product Name
Ratsak 25 Waxblocks Kills Rats & Mice
Application details
Product name:
Ratsak 25 Waxblocks Kills Rats & Mice
Product number:
93584
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 0.025 g/kg brodifacoum ready to use block bait product for control of rats and mice in indoor and outdoor household situations.
Reference details:
67652 - FAST ACTION RATSAK WAXBLOCKS
88846 - The Big Cheese Ultra Power All Weather Block Bait
Active constituents:
Active constituent name
85489 - Brodifacoum
Description of data provided:
Data no
253116
Title
Certificate of analysis
Study date
11/10/2021
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253120
Title
Method validation for the determination of brodifacoum in a Rodenticide Wax Block
Study date
14/06/2022
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253117
Title
Information on ingredients
Study date
April 2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253118
Title
Yates Rodenticide Wax Block - Formula Summary
Study date
07/12/2022
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253121
Title
Ratsak Professional All Weather Wax Blocks
Study date
1/7/2016
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253122
Title
Part 2 Summary
Study date
April 2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253119
Title
Stability testing report Rodenticide Wax Block (54??C x 2 weeks)
Study date
14/06/2022
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
265466
Title
Efficacy of rodenticide baits with decreased concentrations of brodifacoum: Validation of the impact of the new EU anticoagulant regulation
Study date
2019
Auth party contact address
-
Data no
253123
Title
Evaluation of the palatability of experimental bait formulations containing no active constituents for rats under laboratory conditions. One laboratory trial, Bundaberg, Queensland Australia, 2021
Study date
17/09/2021
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253124
Title
Evaluation of the palatability of experimental bait formulations containing no active constituents for mice under laboratory conditions. One laboratory trial, Bundaberg, Queensland Australia, 2021
Study date
17/09/2021
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253125
Title
A field efficacy evaluation of Yates Rodenticide Wax Blocks experimental rodenticide formulation for the control of black rats and mice
Study date
08/09/2022
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
253126
Title
Comparative effect of the three rodenticides warfarin, difenacoum and brodifacoum on eight rodent species in short feeding periods
Study date
1981
Auth party contact address
-
Data no
253127
Title
Part 8 Summary
Study date
May 2023
Auth party contact address
1 GOW ST PADSTOW Australia
Data no
265467
Title
Technical Notes for Guidance on Product Evaluation Appendices to Chapter 7 Product Type 14 Efficacy Evaluation of Rodenticidal Biocidal Products
Study date
February 2009
Auth party contact address
-
Data no
265465
Title
Response to S159(1)(a) Notice
Study date
17/01/2024
Auth party contact address
1 GOW ST PADSTOW Australia
Date
Application Date
Application No
Application Number
139507
Product/Active constituent Name
Application Product Name
DEMAND 100CS Insecticide
Application Date
Application Number
139507
Application Product Name
DEMAND 100CS Insecticide
Application details
Product name:
DEMAND 100CS Insecticide
Product number:
87293
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of the label approval to extend the use to include the control of Australian paralysis tick and Brown dog tick in outdoor areas.
Active constituents:
Active constituent name
44122 - LAMBDA-CYHALOTHRIN
Active constituent name
65658 - LAMBDA-CYHALOTHRIN
Active constituent name
86444 - lambda-cyhalothrin
Description of data provided:
Data no
252848
Title
Part 8 ??? Efficacy and Safety
Study date
2 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
252849
Title
Laboratory efficacy study evaluating the knockdown and residual efficacy of DEMAND?? 100CS against brown dog ticks and Australian paralysis ticks.
Study date
29 Mar 2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
252850
Title
Efficacy of Commodore 10WP and Demon 40WP Insecticides against the brown dog tick, Rhipicephalus sanguineus
Study date
18 Sep 1991
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
252851
Title
Efficacy of Prelude, Demand CS and Demon WP against the Lone Star tick
Study date
7 Aug 1997
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
252852
Title
Residual efficacy of lambda-cyhalothrin on adult ticks
Study date
12 June 1991
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
252853
Title
Laboratory trial to investigate efficacy of Demon, Icon and Cislin 10 against the Australian paralysis tick
Study date
9 Apr 1990
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
139750
Product/Active constituent Name
Application Product Name
NATRIOLE 200SC Insecticide
Application Date
Application Number
139750
Application Product Name
NATRIOLE 200SC Insecticide
Application details
Product name:
NATRIOLE 200SC Insecticide
Product number:
93576
Applicant Name:
NANJING AGROCHEMICAL CO., LTD.
Application purpose and description of use:
Registration of a 200 g/L chlorantraniliprole suspension concentrate product for the control of Lepidopteran species of insect pests in certain vegetables as per the Directions for Use.
Reference details:
61519 - CORAGEN INSECTICIDE
Active constituents:
Active constituent name
92509 - CHLORANTRANILIPROLE
Description of data provided:
Data no
253066
Title
CERTIFICATE OF ANALYSIS
Study date
January 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253063
Title
Determination of accelerated storage stability of Chlorantraniliprole 200SC at +/- 54C
Study date
April 2022
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253064
Title
Formulation Details for Exp Nanj Chlorantraniliprole 200
Study date
April 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253065
Title
SPECIFICATION OF CHLORANTRANILIPROLE 200G/L SC
Study date
April 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253067
Title
MATERIAL SAFETY DATA SHEET
Study date
April 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253068
Title
Material Safety Data Sheet
Study date
July 2014
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253069
Title
MATERIAL SAFETY DATA SHEET SDS/MSDS
Study date
April 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253070
Title
Material Safety Data Sheet
Study date
May 2013
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253071
Title
Material Safety Data Sheet
Study date
October 2016
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260749
Title
Material Safety Data Sheet
Study date
July 2014
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260750
Title
MATERIAL SAFETY DATA SHEET SDS/MSDS
Study date
April 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260751
Title
Material Safety Data Sheet
Study date
May 2013
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260752
Title
Material Safety Data Sheet
Study date
October 2016
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260753
Title
Material safety data sheet
Study date
July 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260754
Title
Material safety data sheet
Study date
July 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
260755
Title
Material safety data sheet
Study date
May 2013
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
267615
Title
DAPF Document: Summary of New & Revised CIPAC MT methods status: Sept. 22, 2020 (v1.0)
Study date
September 2020
Auth party contact address
-
Data no
267616
Title
Determination of stability at 0C of Chlorantraniliprole 200 g/L SC
Study date
May 2022
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253061
Title
Determination of corrosion characteristics (packaging material) of Chlorantraniliprole 200SC
Study date
April 2022
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253062
Title
Determination of persistent foam of Chlorantraniliprole 200SC
Study date
April 2022
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Data no
253060
Title
Bioequivalence of Exp Nanj Chlorantraniliprole 200 and Coragen Insecticide, when applied to control Lepidopteran pests in broccolini. Gatton Queensland Australia 2022
Study date
February 2023
Auth party contact address
11-Zitanyaju, 126 Mengdu Street NANJING China
Date
Application Date
Application No
Application Number
139496
Product/Active constituent Name
Application Product Name
Petroleum Gas, Liquefied
Application Date
Application Number
139496
Application Product Name
Petroleum Gas, Liquefied
Application details
Product name:
Petroleum Gas, Liquefied
Product number:
93551
Applicant Name:
S.C. JOHNSON & SON PTY LTD
Application purpose and description of use:
Registration of a 990 g/kg LIQUEFIED PETROLEUM GAS aerosol product for for the control of crawling insects in household situations, in conjunction with approval of active constituent LIQUEFIED PETROLEUM GAS.
Description of data provided:
Data no
252991
Title
Chemistry and manufacturing information_Active Constituent
Study date
April 2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252992
Title
SUMMARY PART 2 CHEMISTRY AND MANUFACTURE_Active Constituent
Study date
April 2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Date
Application Date
Application No
Application Number
139497
Product/Active constituent Name
Application Product Name
Raid Crawling Insect Spray
Application Date
Application Number
139497
Application Product Name
Raid Crawling Insect Spray
Application details
Product name:
Raid Crawling Insect Spray
Product number:
93552
Applicant Name:
S.C. JOHNSON & SON PTY LTD
Application purpose and description of use:
Registration of a 990 g/kg LIQUEFIED PETROLEUM GAS aerosol product for for the control of crawling insects in household situations, in conjunction with approval of active constituent LIQUEFIED PETROLEUM GAS.
Description of data provided:
Data no
252993
Title
Chemistry and manufacturing information_Product
Study date
April 2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252994
Title
SUMMARY PART 2 CHEMISTRY AND MANUFACTURE_Product
Study date
April 2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252995
Title
Laboratory Study to Determine the Direct Spray Efficacy of Raid Crawling Insect Spray-B Aerosol and Butane-A Aerosol Against a Range of Arthropod Pests. PRC Report No. R22-2204.
Study date
22/12/2022
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
261783
Title
Simulated field study to determine the direct spray immobilisation of Raid Carawling Insect Spray-B Aerosol against spiders and cockroaches
Study date
30/10/2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
261784
Title
Response to S159 Notice
Study date
08/11/2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252996
Title
SUMMARY PART 8 EFFICACY AND SAFETY_Product
Study date
April 2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252997
Title
Efficacy and safety other information_Product
Study date
April 2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252998
Title
Waiver of an environmental assessment for Raid Crawling Insect Spray
Study date
14/03/2023
Auth party contact address
160 EPPING RD LANE COVE Australia
Data no
252999
Title
APVMA Pre-application Assistance ID 129629
Study date
5 Feb 2021
Auth party contact address
160 EPPING RD LANE COVE Australia
Date
Application Date
Application No
Application Number
139403
Product/Active constituent Name
Application Product Name
SA WATER COPPER SULPHATE ALGICIDE
Application Date
Application Number
139403
Application Product Name
SA WATER COPPER SULPHATE ALGICIDE
Application details
Product name:
SA WATER COPPER SULPHATE ALGICIDE
Product number:
51854
Applicant Name:
SOUTH AUSTRALIAN WATER CORPORATION
Application purpose and description of use:
Variation of product registration and/or label approval to (summarise proposed variation).
Description of data provided:
Data no
262146
Title
Wirrina Water Treatment Plant – Local Catchment Environmental Assessment
Study date
24 August 2023
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Data no
262155
Title
Wirrina WTP – Catchment Barrier Status Report
Study date
17 February 2023
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Data no
264220
Title
Wirrina Catchment Golf Course Dam
Study date
23/9/19 and 17/10/19
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Date
Application Date
Application No
Application Number
139440
Product/Active constituent Name
Application Product Name
IMTRADE EDGE UNIFY 900 WG HERBICIDE
Application Date
Application Number
139440
Application Product Name
IMTRADE EDGE UNIFY 900 WG HERBICIDE
Application details
Product name:
IMTRADE EDGE UNIFY 900 WG HERBICIDE
Product number:
93531
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 890g/kg Propyzamide + 10g/kg Nicotinic Acid water dispersible granule product for selective control of certain grasses and broadleaf weeds in Canola, Mustard, Winter Grain Legumes, Legume Seed Crops and Pastures as per the Directions for Use table.
Reference details:
63332 - IMTRADE EDGE 900 WG HERBICIDE
Active constituents:
Active constituent name
81423 - Propyzamide
Description of data provided:
Data no
252601
Title
CoA Propyzamide Technical
Study date
Oct 2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252602
Title
Niacin Specification - USP38 -P.4541
Study date
2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
262511
Title
CoA Nicotinic Acid
Study date
10/11/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252598
Title
Edge Plus Method Validation for Propyzamide ??? January 2021
Study date
04/01/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252599
Title
Edge Plus Method Validation for Nicotinic Acid - January 2021
Study date
07/01/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252596
Title
Edge Plus 1 Batch Analysis for Propyzamide ??? January 2021
Study date
13/01/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252597
Title
Edge Plus 1 batch Analysis for Nicotinic Acid - January 2021
Study date
08/01/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252595
Title
Formulation & Stability Report - Imtrade Edge Plus WG Herbicide
Study date
19/01/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252600
Title
Safety Data Sheets for other Constituents
Study date
25/01/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252594
Title
Method of Manufacture (inc. Quality Controls) - Imtrade Edge Plus WG Herbicide
Study date
19/01/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252606
Title
Investigation into the Efficacy of IMTRADE EDGE PLUS WG HERBICIDE compared to IMTRADE EDGE 900 WG HERBICIDE for the control of Annual Ryegrass when applied as a Pre-Emergent IBS treatment to Canola cv. Bonito ??? One Trial, Corrigin, WA.
Study date
2/12/2020
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252611
Title
Investigation of the Bio-efficacy and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE to that of IMTRADE EDGE UNIFY?? WG HERBICIDE applied Post-Emergent for the control of Annual Ryegrass in a commercial Canola cv. Bonito crop. ??? One Trial, Moodiarrup, WA.
Study date
30/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252612
Title
Investigation of the Bio-efficacy of IMTRADE EDGE 900 WG HERBICIDE to that of IMTRADE EDGE UNIFY?? WG HERBICIDE applied Post-Emergent for the control of Annual Ryegrass in a commercial Field Pea cv. Parafield + Twilight Crop ??? One Trial, West Kondinin, WA.
Study date
30/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252613
Title
Investigation of the Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? WG HERBICIDE when applied PSPE and Post-Emergent in Canola cv. Bonito crop ??? One Trial, Dalwallinu, WA.
Study date
30/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252614
Title
Investigation of the Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? WG HERBICIDE when applied PSPE and Post-Emergent in a Field Pea cv. Twilight crop ??? One Trial, Dalwallinu, WA.
Study date
30/09/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252615
Title
Investigation into the Bio-efficacy of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied Post-Emergent for the control of Annual Ryegrass, Brome Grass and Volunteer Barley in a commercial Faba Bean cv. Bendoc crop ??? One Trial, Saddleworth, SA.
Study date
24/02/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252618
Title
Investigation into Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied PSPE and Post-Emergent in a Canola cv. Bonito crop ??? One Trial, Arthur River, WA.
Study date
10/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252619
Title
Investigation into Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICDE when applied PSPE and Post-Emergent in Lupins cv. Mandalup ??? One Trial, Newdegate, WA.
Study date
13/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252620
Title
Investigation into Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG Herbicide when applied PSPE and Post Emergent in Field Peas cv. Twilight ??? One Trial, Newdegate, WA.
Study date
31/01/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252621
Title
Investigation into Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied PSPE and Post-Emergent in a Canola cv. Bonito crop ??? One Trial, Newdegate, WA.
Study date
10/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252622
Title
Investigation into Bio-equivalency and Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied PSPE and Post-Emergent in Faba Beans cv. Fiesta ??? One Trial, Newdegate, WA.
Study date
Jan 2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252609
Title
Investigation into the Efficacy of IMTRADE EDGE PLUS HERBICIDE compared to IMTRADE EDGE 900 WG HERBICIDE of the control of annual grass weeds in a commercial Chickpea cv. Kyabara crop ??? One Trial, Condamine, QLD.
Study date
12/11/2020
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252625
Title
Comments to Support Efficacy and Host Crop Safety Data submitted.
Study date
31/03/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252610
Title
Investigation into the Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE PLUS HERBICIDE when applied Post-Emergent in a commercial Chickpea cv. Kyabra crop ??? One Trial, Condamine, QLD.
Study date
01/12/2020
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252623
Title
Investigation into the Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied as a Post-Sowing Pre-Emergent and Post-Emergent application for the control of Annual Ryegrass in a commercial Faba Bean cv. Samira crop ??? One Trial, Saddleworth, SA.
Study date
03/02/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252624
Title
Investigation into the Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied Post-Emergent for the control of Annual Ryegrass in commercial Faba Beans cv. Samira crop ??? One Trial, Saddleworth, SA.
Study date
03/02/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252616
Title
Investigation of the Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied Post-Sowing Pre-Emergent (PSPE) and Post-Emergent for the control of Annual Ryegrass and Barley Grass in a commercial Faba Bean cv. Samiras crop ??? One Trial, Waterloo, SA.
Study date
06/05/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252617
Title
Investigation of the Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE UNIFY?? 900 WG HERBICIDE when applied Post-Sowing Pre-Emergent (PSPE) and Post-Emergent for the control of Annual Ryegrass and Volunteer Barley in a commercial Lentil cv. Hallmark crop ??? One Trial, Bute, SA.
Study date
13/05/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252607
Title
Investigation into the Host Crop Safety of IMTRADE EDGE 900 WG HERBICIDE and IMTRADE EDGE PLUS HERBICIDE when applied Post-Emergent in Lupin cv. Gunyidi ??? One Trial, Corrigin, WA.
Study date
02/12/2020
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252608
Title
Investigation into the Host Crop Safety of IMTRADE DGE 90 WG HERBICIDE and IMTRADE EDGE PLUS HERBICIDE when applied Post-Emergent in Field Pea cv. Twilight & Parafield ??? One Trial, Kondinin, WA.
Study date
04/11/2020
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
262512
Title
Environmental Assessment - Imtrade Edge Unify 900 WG Herbicide
Study date
27/11/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252603
Title
Argument to satisfy AgVet Chemicals Code Act 1994 (Cth) s.14(3) in countering the commercial in confidence aspects of the reference product???s non-protected data
Study date
04/01/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252604
Title
OH and S Report - Imtrade Edge UNIFY?? 900 WG Herbicide
Study date
14/02/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
252605
Title
Determination of Residues of Imtrade Edge 900 WG Herbicide (Propyzamide) in Canola and Winter Grain Legumes
Study date
21/11/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
262510
Title
Argument Dispelling Any Requirement for the Residues Determination by Field Trials of Nicotinic Acid in Commodities Treated with Imtrade Edge Unify WG Herbicide
Study date
10/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
138962
Product/Active constituent Name
Application Product Name
Phyton Copper Fungicide
Application Date
Application Number
138962
Application Product Name
Phyton Copper Fungicide
Application details
Product name:
Phyton Copper Fungicide
Product number:
93393
Applicant Name:
MARKETING ARM INTERNATIONAL,INC
Application purpose and description of use:
Registration of a 60 g/L copper present as copper sulphate pentahydrate soluble concentrate product for the control of various diseases of vegetables and ornamentals as per the Directions for Use table.
Reference details:
50722 - LIQUICOP COPPER FUNGICIDE
Description of data provided:
Data no
255147
Title
21407-1-AA Copper Sulphate Pentahydrate Certificate of Analysis
Study date
13 Dec 2017
Data no
255148
Title
Copper sulphate pentahydrate Certificate of Analysis
Study date
18 August 2022
Data no
255151
Title
Copper in Phyton and Related Materials by Atomic Absorption Spectrophotometry
Study date
2006
Data no
255150
Title
Phyton Certificate of Analysis.
Study date
2018
Data no
255155
Title
Raw Material specifications as provided by product manufacturer.
Study date
2018
Data no
255156
Title
Phyto Chemistry Dossier DC25-44367629
Study date
31 July 2018
Data no
255152
Title
EN-016-PC Determination of Physical-chemical properties of Phyton Formulation
Study date
2018
Data no
255153
Title
EN-016-PC-ADD Determination of Physical-chemical properties of Phyton Formulation.
Study date
2018
Data no
255149
Title
20LT Plastic Container Specification
Study date
31 July 2018
Data no
251107
Title
Chemistry Dosser DC10-958495999.
Study date
30 May 2022.
Data no
255154
Title
Manufacturers Declaration
Study date
2018
Data no
251118
Title
Evaluation of Phyton 62.8 SL for the control of bacterial leaf spot (Xanthomonas campestris) in capsicums cv. Warlock Bowen, Queensland, 2017
Study date
2017
Data no
251119
Title
Evaluation of Phyton 62.8 SL for control of lettuce anthracnose (Microdochium panattonianum) in cos lettuce cv. Rafael Devonport, Tasmania, 2017
Study date
2017
Data no
251120
Title
Evaluation of Phyton 62.8 SL for the control of downy mildew (Peronospora destructor) in red onions cv. Monastrell Forthside, Tasmania, 2017-18
Study date
2017
Data no
251121
Title
Evaluation of Phyton 62.8 SL for the control of early blight (Alternaria solani) in potato cv. Nadine Upper Tenthill, Queensland, 2017
Study date
2017
Data no
251122
Title
Evaluation of Phyton 62.8 SL for the control of bacterial speck (Pseudomonas syringae pv. tomato) in tomato cv. Entice
Study date
2017
Data no
251123
Title
Phyton incidence and severity report
Study date
2022
Data no
251124
Title
Efficacy trial for registration of Phyton systemic copper fungicide in cauliflowers at Clifton,Queensland.
Study date
2020
Data no
251125
Title
Efficacy Trial for registration of Phyton Systemic Copper fungicide in Broccoli, at Laidley, Queensland
Study date
2020
Data no
251126
Title
Efficacy and crop safety of Phyton on Phoma lingam in Pak Choy
Study date
2020
Data no
251127
Title
Efficacy Trials for registration of Phyton Systemic Copper fungicide in cauliflowers (Brassica oleracea pv.botrytis) at Forth,Tasmania
Study date
2020
Data no
251128
Title
Efficacy Trial for registration of Phyton Systemic Copper fungicide in Broccoli in Werribee, Victoria.
Study date
2020
Data no
251129
Title
Efficacy trials for registration of Phyton Systemic Copper Fungicide Trial in Greenhouse Tomatoes at Lara, Victoria.
Study date
2019
Data no
251130
Title
Efficacy trial for registration of Phyton Systemic Copper Fungicide in field Tomatoes in the Lockyer Valley Queensland
Study date
2019
Data no
251131
Title
Efficacy trial for registration of Phyton Systemic Copper Fungicide in Greenhouse Cucumber at Bundaberg, Queensland.
Study date
2019
Data no
251132
Title
Efficacy Trial for registration of Phyton Systemic Copper fungicide in Pumpkins Carpendale in the Lockyer Valley, Queensland.
Study date
2020
Data no
251133
Title
Efficacy Trial for registration of Phyton Systemic Copper fungicide in Greenhouse cucumbers in Penfield, South Australia.
Study date
2020
Data no
251134
Title
Efficacy trial for registration of Phyton Systemic Copper Fungicide Trial in field Lettuce in Werribee South, Victoria.
Study date
2019
Data no
251135
Title
MAI Phyton Commercial Scale Copper Fungicide Trial ??? Field Crisp Head Lettuce 2, Werribee South.
Study date
2019
Data no
251136
Title
Efficacy Trial for registration of Phyton Systemic Copper fungicide in Green Beans at Brightview in the Lockyer Valley.
Study date
2020
Data no
251137
Title
Efficacy Trials for registration of Phyton Systemic Copper fungicide in Green Beans at Mount Tarampa, Lockyer Valley, Queensland
Study date
2020
Data no
251138
Title
ONION MODEL y ??? rate FOR ASSESSMENT INC 8DAAB
Study date
2022
Data no
251139
Title
CAPSICUM MODEL y ??? rate FOR ASSESSMENT SEV 7DAAA
Study date
2022
Data no
251140
Title
CAPSICUM MODEL y ??? rate + blk cts FOR ASSESSMENT SEV 7DAAA
Study date
2022
Data no
251141
Title
POTATO MODEL y ??? rate FOR ASSESSMENT SEV 10DAAD
Study date
2022
Data no
251142
Title
TOMATO MODEL y ??? rate FOR ASSESSMENT SPECK SEV 7DAAC
Study date
2022
Data no
251143
Title
An In Vitro Study of the Nature of Protective Activities of Copper Sulphate, Copper Hydroxide and Copper Oxide Against Conidia of Venturia inaequalis
Study date
2006
Auth party contact address
-
Data no
251144
Title
Copper-tolerance in Pseudomonas syringae pv. tomato and Xanthomonas spp. and the control of diseases associated with these pathogens in tomato and pepper. A systematic literature review
Study date
2017
Auth party contact address
-
Data no
251145
Title
In vitro testing of Phyton 27
Study date
2021
Data no
251146
Title
STUDIES UPON THE COPPER FUNGICIDES V. A CRITICAL EXAMINATION OF THE FUNGICIDAL VALUE OF COPPER COMPOUNDS
Study date
1942
Auth party contact address
-
Data no
251147
Title
Studies upon the copper fungicides VI. The solution of copper from Bordeaux and Burgundy mixtures
Study date
1943
Auth party contact address
-
Data no
251148
Title
Solubilization of Copper by Leaves and Water-soluble Acids from Leaf Wax
Study date
1957
Auth party contact address
-
Data no
251149
Title
Effect of pH, Concentration and Temperature on Copper and Zinc Hydroxide Formation/Precipitation in Solution
Study date
2011
Auth party contact address
-
Data no
251150
Title
Interactions Between Copper and Chlorine Disinfectants: Chlorine Decay, Chloramine Decay and Copper Pitting
Study date
2005
Auth party contact address
-
Data no
251151
Title
STUDIES UPON THE COPPER FUNGICIDES III. THE DISTRIBUTION OF FUNGICIDAL PROPERTIES AMONG CERTAIN COPPER COMPOUNDS
Study date
1937
Auth party contact address
-
Data no
251152
Title
Phyton Fungicide Efficacy
Study date
2023
Data no
251102
Title
Cold Stability & Dilution Stability Analysis . Report No. ACS2024464-1
Study date
7 Oct 2020
Data no
251103
Title
Determine qualitative elemental composition of Phyton sediment. Report No. SEM/20061.
Study date
19 Oct 2020.
Data no
251104
Title
Determine qualitative elemental composition of Phyton sediment. . Report No. SEM/20064.
Study date
2 November 2020
Data no
251105
Title
Determine qualitative elemental composition of Phyton sediment. Report No. SEM/20078.
Study date
21 December 2020.
Data no
251106
Title
Discussion on copper chloride in Phyton Seacole letter.
Study date
January 28 2021.
Data no
251099
Title
PERMIT TO ALLOW RESEARCH USE AND SUPPLY OF AN UNREGISTERED AGVET CHEMICAL PRODUCT FOR THE CONTROL OF VARIOUS FUNGAL DISEASES IN VARIOUS CROPS
Study date
28 November 2018
Data no
251108
Title
Liquicop Copper Fungicide - Label
Study date
2008
Auth party contact address
-
Data no
251109
Title
Copper sulfate pentahydrate
Study date
2021
Auth party contact address
-
Data no
251113
Title
Copper Sulphate PubChem.
Study date
26 May 2022
Auth party contact address
-
Data no
251100
Title
Item 25 Agricultural Chemical Product Chemistry Evaluation (Chemistry Module 2.3). Report 117069_86925
Study date
2 October 2019.
Data no
251101
Title
Module 2.3 Supplementary Dossier. DC10- 95849599.
Study date
2021
Data no
251097
Title
. PAA Notice (DCPAA2 10674598).
Study date
30 May 2017
Data no
251098
Title
Notice of Decision ??? Item 25. 117069_86925.
Study date
23 August 2019
Data no
255168
Title
PAA Written Advice DCPAA2-10674598A
Study date
June 2017
Data no
251116
Title
Environment Dossier, DC10-958495999.
Study date
26 May 2022
Data no
251169
Title
Copper residues in lettuce
Study date
2022
Data no
251170
Title
Copper residues in cucumbers
Study date
2022
Data no
255158
Title
Residue exposure to copper from use of Phyton
Study date
1/8/2018
Data no
251171
Title
Residues Argument
Study date
2023
Data no
251163
Title
PAA ID: DCPAA2-10674598A
Study date
2017
Data no
251164
Title
86925 - 117069 - Phyton Copper Fungicide - Item 25 APVMA Response
Study date
2019
Data no
251165
Title
Copper as an Essential for Plant Growth
Study date
1931
Auth party contact address
-
Data no
251166
Title
Copper in Plants
Study date
2005
Auth party contact address
-
Data no
251167
Title
Uptake and accumulation of copper by roots and shoots of maize (Zea mays L.)
Study date
2001
Auth party contact address
-
Data no
251168
Title
Studies upon the copper fungicides XII. Absorption of complexes by leaves
Study date
1963
Auth party contact address
-
Data no
255167
Title
.Phyton 27. Acute Dermal Toxicity in Rats. Study 20861
Study date
January 2007
Data no
255165
Title
Phyton 27. Primary Eye Irritation Study in Rabbits. Study 9988.
Study date
July 2008.
Data no
255164
Title
Phyton 27. Acute Inhalation Toxicity Study in Rats - Limit test. Study 24655.
Study date
June 2008.
Data no
255166
Title
Phyton 27. Acute Oral Toxicity Up and Down Procedure in Rats. Study 24654
Study date
June 2008
Data no
255161
Title
Phyton 27. Primary Skin Irritation Study in Rabbits. Study 24656.
Study date
June 2008
Data no
255162
Title
Phyton 27. Dermal Sensitization Study in Guinea Pig (Buehler Method). Study 24657.
Study date
July 2008.
Data no
255163
Title
Toxicology Dossier. . DC25-44367629.
Study date
30 May 2018
Data no
255159
Title
Opinion of the TC NES on the Human Health Part of Industry Voluntary Risk Assessments on Copper and Copper compounds. European Commission Directorate
Study date
2008
Auth party contact address
-
Data no
255160
Title
Phyton SDS
Study date
June 1 2015
Data no
251117
Title
HUMAN HEALTH RISK ASSESSMENT TECHNICAL REPORT
Study date
23 April 2019
Data no
251114
Title
Copper Sulphate SDS.
Study date
16 April 201
Auth party contact address
-
Data no
251115
Title
Copper sulfate Thurston County Review Summary
Study date
28 July 2011.
Data no
251110
Title
SDS for copper sulphate pentahydrate SDS ??? Alpha Chemicals
Study date
16 April 2019
Auth party contact address
-
Data no
251111
Title
. Peer review of the pesticide risk assessment of the active substance copper compounds copper(|), copper(ll) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper(l) oxide, Bordeaux mixture. .
Study date
20 December 2017
Auth party contact address
-
Data no
251112
Title
Copper Sulfate Technical Fact Sheet; National Pesticide Information Center, Oregon State University Extension Services.
Study date
2012
Data no
255157
Title
Environment Risk DC25-44367629
Study date
31/7/2018
Date
Application Date
Application No
Application Number
138676
Product/Active constituent Name
Application Product Name
Nufarm Galaxy Herbicide
Application Date
Application Number
138676
Application Product Name
Nufarm Galaxy Herbicide
Application details
Product name:
Nufarm Galaxy Herbicide
Product number:
92149
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product label approval to include aerial application for the same crops, weeds controlled, application rates and tank mixes as currently registered for ground boom application.
Active constituents:
Active constituent name
91686 - Pyrasulfotole
Description of data provided:
Data no
257005
Title
92149/138676 Nufarm Galaxy Herbicide - Response to S159 Notice of 28 June 2023
Study date
11 July 2023
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
250061
Title
Nufarm Galaxy Herbicide Executive Summary
Study date
14 Feb 2023
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
250062
Title
Nufarm Galaxy Herbicide draft label marked up 14022023
Study date
13 Feb 2023
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
250060
Title
Environmental Technical Report for Application no. 131089, Permit 91161
Study date
1 June 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
138133
Product/Active constituent Name
Application Product Name
Elura Flavoured Oral Solution for Cats
Application Date
Application Number
138133
Application Product Name
Elura Flavoured Oral Solution for Cats
Application details
Product name:
Elura Flavoured Oral Solution for Cats
Product number:
93160
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
This application is to apply for the registration of Capromorelin Oral Solution for Cats which contains 20 mg/mL of capromorelin tartrate. Approval of the API will be undertaken concurrently with this application.
The proposed indication is for body weight gain in cats experiencing poor appetite or unintended weight loss resulting from chronic medical conditions.
The recommended dose is 2 mg/kg body weight (equivalent to 0.1 mL/kg of the final solution), once daily.
Description of data provided:
Data no
275755
Title
Validation of Analytical
Study date
21/10/2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275756
Title
Validation of Residual Solvents in ATA002-11 by GC-HS
Study date
24/11/2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275757
Title
Method Validation Report for Determination of Chiral Purity of FP-197 by HPLC
Study date
13/12/2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275758
Title
Method Validation Report for Determination of Tartaric Acid in FP-197 by HPLC
Study date
29/10/2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275759
Title
Method Validation Report for Determination of Identity, Assay and Impurity Content of FP-197 by HPLC
Study date
12/05/2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275760
Title
Validation of Residual TFA in ATA002-11 by HS-GC-ECD
Study date
20/01/2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275752
Title
Description of Manufacturing Process and Process Controls
Study date
04/10/2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275753
Title
Control of Materials
Study date
07/12/2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275754
Title
Stability Data
Study date
09/11/2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248164
Title
Justification of specification
Study date
6 May 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248167
Title
Analytical procedures
Study date
12 October 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248168
Title
Validation summary
Study date
7 August 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248169
Title
Analytical procedures for excipients
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248159
Title
Manufacturers GMP certificates
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248160
Title
Manufacturing process development
Study date
6 May 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248161
Title
Formulation development
Study date
6 May 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248165
Title
Container closure system
Study date
8 November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248163
Title
Control of critical steps
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
249997
Title
Steps of Manufacture
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248166
Title
Manufacturing In-Process controls
Study date
3 November 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248162
Title
Manufacturing process flow
Study date
6 May 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248156
Title
Applicants overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248157
Title
Components of drug product
Study date
6 May 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248158
Title
CofA's excipients
Study date
31 March 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275761
Title
CofA - excipient
Study date
14/5/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275762
Title
CofA - Excipient
Study date
7/5/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275763
Title
Product specifications
Study date
15/7/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275767
Title
CofA excipient
Study date
23/4/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275766
Title
Stability summary and conclusions
Study date
12/7/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275764
Title
Stability data
Study date
2/7/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248170
Title
Stability
Study date
6 May 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250029
Title
Chromatograms T0
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250030
Title
Chromatograms T1m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250031
Title
Chromatograms T2m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250032
Title
Chromatograms T3m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250033
Title
Chromatograms T6m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250034
Title
Chromatograms T9m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250035
Title
Chromatograms T12m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250036
Title
Chromatograms T18m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250037
Title
Chromatograms T24m
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250038
Title
Chromatograms T24m Deg prod
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
250039
Title
Chromatograms T24 RRTO
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248111
Title
Clinical efficacy summary
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248112
Title
Report AT002-FCL-12-001 Field study
Study date
30 June 2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248113
Title
Report AT002-FCL-13-002 Pilot efficacy study
Study date
15 January 2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248114
Title
Report AT002-FCL-14-003 - field study
Study date
5 November 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248115
Title
Report AT002-FCL-16-004 Field study
Study date
30 March 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248116
Title
Report 1982R-60-03-302 Field efficacy and safety
Study date
27 March 2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248117
Title
Report 5982R-10-03-234 - field safety study
Study date
21 June 2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248143
Title
Effect of Single Doses of Capromorelin and Ghrelin On Esophageal Reflux Parameters and Esophageal Function: A Randomized, Double-Blind, Placebo-Controlled Study.
Study date
11 November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248144
Title
Capromorelin: a ghrelin receptor agonist and novel therapy for stimulation of appetite in dogs
Study date
2018
Auth party contact address
-
Data no
248145
Title
Body composition in chronic kidney disease
Study date
2015
Auth party contact address
-
Data no
248146
Title
Acute administration of acyl, but not desacyl ghrelin, decreases blood pressure in healthy humans
Study date
2017
Auth party contact address
-
Data no
248147
Title
Changes in renal sympathetic nerve activity, heart rate and arterial blood pressure associated with eating in cats
Study date
1987
Auth party contact address
-
Data no
248148
Title
Report 97-1340-20 tolerance study
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248149
Title
Plasma clearance
Study date
2004
Auth party contact address
-
Data no
248150
Title
Volumes of distribution
Study date
2004
Auth party contact address
-
Data no
248152
Title
Chronic use of maropitant for the management of vomiting and inappetence in cats with chronic kidney disease: a blinded, placebo-controlled clinical trial.
Study date
2015
Auth party contact address
-
Data no
248153
Title
Acute stress hyperglycemia in cats is associated with struggling and increased concentrations of Lactate and Norepinephrine.
Study date
2002
Auth party contact address
-
Data no
248040
Title
Anamorelin for advanced non-small-cell lung cancer with cachexia: Systematic review and meta-analysis
Study date
2017
Auth party contact address
-
Data no
248041
Title
Preclinical pharmacology of CP-424,391, an orally active pyrazolidinone-piperidine growth hormone secretagogue
Study date
2001
Auth party contact address
-
Data no
248042
Title
Disorders of Growth Hormone
Study date
2015
Auth party contact address
-
Data no
248043
Title
Is there an effect of ghrelin/ghrelin analogs on cancer? A systematic review
Study date
2016
Auth party contact address
-
Data no
248044
Title
Two ghrelin receptor agonists for adults with malnutrition: a systematic review and meta-analysis
Study date
2016
Auth party contact address
-
Data no
248045
Title
Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials
Study date
2016
Auth party contact address
-
Data no
248046
Title
Effects of an oral growth hormone secretagogue in older adults
Study date
2009
Auth party contact address
-
Data no
248047
Title
The homeostatic force of Ghrelin
Study date
2018
Auth party contact address
-
Data no
248027
Title
Efficacy and Safety of Relamorelin in Diabetics with Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study
Study date
2017
Auth party contact address
-
Data no
248028
Title
ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia;
Study date
2017
Auth party contact address
-
Data no
248029
Title
Distribution of mRNA encoding the growth hormone secretagogue receptor in brain and peripheral tissues
Study date
1997
Auth party contact address
-
Data no
248030
Title
A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia
Study date
2019
Auth party contact address
-
Data no
248031
Title
Efficacy and Safety of Ghrelin Agonists in Patients with Diabetic Gastroparesis: A Systematic Review and Meta-Analysis
Study date
2019
Auth party contact address
-
Data no
248032
Title
A Receptor in Pituitary and Hypothalamus That Functions in Growth Hormone Release
Study date
1996
Auth party contact address
-
Data no
248033
Title
Purification and characterization of feline ghrelin and its possible role
Study date
2007
Auth party contact address
-
Data no
248034
Title
Ghrelin is a growth-hormone-releasing acylated peptide from stomach
Study date
1999
Auth party contact address
-
Data no
248035
Title
Longitudinal weight change during CKD progression and its association with subsequent mortality
Study date
2018
Auth party contact address
-
Data no
248036
Title
Ghrelin is a growth-hormone-releasing acylated peptide from stomach
Study date
2016
Auth party contact address
-
Data no
248037
Title
Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis
Study date
2013
Auth party contact address
-
Data no
248038
Title
Ghrelin
Study date
2015
Auth party contact address
-
Data no
248180
Title
Changes in renal sympathetic nerve activity, heart rate and arterial blood pressure associated with eating in cats.
Study date
1987
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248181
Title
Part 8 Efficacy-Safety Overview
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248039
Title
Effects of an oral ghrelin mimetic on body composition and clinical outcomes in healthy older adults: a randomized trial
Study date
2008
Auth party contact address
-
Data no
248048
Title
General Pharmacology Summary
Study date
25 July 1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248049
Title
Summary Pharmacology properties
Study date
8 May 1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248050
Title
Pharmacology summary
Study date
21 July 2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248051
Title
API-confidential material package
Study date
21 July 2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
247976
Title
Applicants summary - preclinical-pharmacology
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
247977
Title
A prospective investigation of the prevalence and prognostic significance of weight loss and changes in body condition in feline cancer patients
Study date
2007
Auth party contact address
-
Data no
247978
Title
Efficacy and Safety of Relamorelin in Diabetics with Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study.
Study date
2017
Auth party contact address
-
Data no
247979
Title
ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia.
Study date
2017
Auth party contact address
-
Data no
247980
Title
Growth hormone (GH) secretagogues and neuroendocrine regulation of GH secretion (short communication).
Study date
1999
Auth party contact address
-
Data no
247981
Title
Evaluation of Weight Loss Over Time in Cats with Chronic Kidney Disease.
Study date
2016
Auth party contact address
-
Data no
247982
Title
The relationship between body weight, body condition, and survival in cats with heart failure.
Study date
2010
Auth party contact address
-
Data no
247983
Title
Distribution of mRNA encoding the growth hormone secretagogue receptor in brain and peripheral tissues.
Study date
1997
Auth party contact address
-
Data no
247984
Title
A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia.
Study date
2019
Auth party contact address
-
Data no
247985
Title
Ghrelin in domestic animals: distribution in stomach and its possible role.
Study date
2001
Auth party contact address
-
Data no
247986
Title
Efficacy and Safety of Ghrelin Agonists in Patients with Diabetic Gastroparesis: A Systematic Review and Meta-Analysis.
Study date
2019
Auth party contact address
-
Data no
247987
Title
A Receptor in Pituitary and Hypothalamus that Functions in Growth Hormone Release.
Study date
1996
Auth party contact address
-
Data no
247988
Title
Purification and characterization of feline ghrelin and its possible role.
Study date
2007
Auth party contact address
-
Data no
247989
Title
Prognostic factors in cats with chronic kidney disease.
Study date
2007
Auth party contact address
-
Data no
247990
Title
Ghrelin is a growth-hormone-releasing acylated peptide from stomach.
Study date
1999
Auth party contact address
-
Data no
247991
Title
Longitudinal weight change during CKD progression and its association with subsequent mortality.
Study date
2018
Auth party contact address
-
Data no
247992
Title
Ghrelin and the Cardiovascular System.
Study date
2016
Auth party contact address
-
Data no
247993
Title
The use of focused cardiac ultrasound to screen for occult heart disease in asymptomatic cats.
Study date
2019
Auth party contact address
-
Data no
247994
Title
Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis.
Study date
2013
Auth party contact address
-
Data no
247995
Title
Ghrelin
Study date
2015
Auth party contact address
-
Data no
247996
Title
Effects of an oral ghrelin mimetic on body composition and clinical outcomes in healthy older adults: a randomized trial
Study date
2008
Auth party contact address
-
Data no
247997
Title
Anamorelin for advanced non-small-cell lung cancer with cachexia: Systematic review and meta-analysis
Study date
2017
Auth party contact address
-
Data no
247998
Title
Preclinical pharmacology of CP-424,391, an orally active pyrazolidinone-piperidine growth hormone secretagogue
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
247999
Title
Association between body condition and survival in dogs with acquired chronic kidney disease
Study date
2011
Auth party contact address
-
Data no
248000
Title
The effect of the ghrelin-receptor agonist capromorelin on glucose metabolism in healthy cats.
Study date
2020
Auth party contact address
-
Data no
248001
Title
Cut points for screening blood glucose concentrations in healthy senior cats.
Study date
2017
Auth party contact address
-
Data no
248002
Title
Disorders of Growth Hormone.
Study date
2015
Auth party contact address
-
Data no
248003
Title
Factors associated with survival in dogs with chronic kidney disease.
Study date
2018
Auth party contact address
-
Data no
248004
Title
Is there an effect of ghrelin/ghrelin analogy on cancer? A systematic review;
Study date
2016
Auth party contact address
-
Data no
248005
Title
The Safety and Efficacy of Growth Hormone Secretagogues.
Study date
2018
Auth party contact address
-
Data no
248006
Title
Two ghrelin receptor agonists for adults with malnutrition: a systematic review and meta-analysis
Study date
2016
Auth party contact address
-
Data no
248007
Title
Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials.
Study date
2016
Auth party contact address
-
Data no
248008
Title
Strong associations of nine-point body condition scoring with survival and lifespan in cats.
Study date
2018
Auth party contact address
-
Data no
248009
Title
Effects of an oral growth hormone secretagogue in older adults.
Study date
2009
Auth party contact address
-
Data no
248010
Title
Evaluation of the safety of daily administration of capromorelin in cats.
Study date
2018
Auth party contact address
-
Data no
248011
Title
The Homeostatic Force of Ghrelin.
Study date
2018
Auth party contact address
-
Data no
248012
Title
General Pharmacology Summary
Study date
25 July 1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248013
Title
Summary of Pharmacological properties
Study date
8 May 1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248014
Title
Pharmacology summary
Study date
21 July 2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248015
Title
API confidential material package
Study date
4 February 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248016
Title
Report 7B81S-60-02-221 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248017
Title
Report 7B81S-60-02-224 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248018
Title
Report 7B81S-60-02-225 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248019
Title
Report 7B81W-60-02-229 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248020
Title
Report 7B81W-60-02-230 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248021
Title
Report 7B81W-60-02-232 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248022
Title
Report 7B81W-60-02-246 - efficacy
Study date
2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248023
Title
Report 7B81W-60-02-256 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248024
Title
Report 7B81W-60-02-264 - efficacy
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248025
Title
Report 7B81W-60-03-269 - efficacy
Study date
2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248026
Title
Applicants Pharmacology summary
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248154
Title
Report DM1996-424391-005 - PK iv/oral dose
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248155
Title
Report DM2006-CP424391-037 Oral PK
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248076
Title
Report 7B81W-60-03-272 Efficacy
Study date
2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248077
Title
Report 7B81W-60-03-273 - efficacy
Study date
2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248078
Title
Report DM1995-424391-002 PK study
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248079
Title
Report DM1996-424391-007 pharmacology
Study date
31 January 1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248080
Title
Report DM1997-424391-019 metabolism
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248081
Title
Report DM1998-424391-018 - PK study
Study date
9 June 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248082
Title
Report DM1998-424391-020 metabolism
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248083
Title
Report DM1998-424391-021 metabolism
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248084
Title
DM1998-424391-022 PK study
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248085
Title
Report DM1999-424391-029 metabolism study
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248086
Title
Report DM1999-424391-030 metabolism study
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248087
Title
Report DM1999-424391-033 Distribution study
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248088
Title
Report DM1996-424391-009 Method validation
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248089
Title
Report AT002-FPK-12-001 Bioanalytical report
Study date
May 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248090
Title
Report AT002-FPK-12-002 Bioanalytical report
Study date
August 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248091
Title
Report AT002-FPK-12-003 Bioanalytical report
Study date
November 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248092
Title
Report AT002-FPK-12-004 Bioanalytical report
Study date
November 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248093
Title
Report AT002-FPK-12-005 - Bioanalytical report
Study date
January 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248094
Title
Report AT002-FPK-13-006 Dose determination
Study date
3 June 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248095
Title
Report AT002-FPK-14-007 Dose determination
Study date
October 2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248096
Title
Report AT002-FPK-14-008 Dose determination
Study date
February 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248097
Title
Report AT002-FPK-16-009 Dose determination
Study date
December 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248098
Title
Report AT002-FPK-17-010 PK study
Study date
23 August 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248099
Title
Report AT002-FPK-17-011 part a - PK study
Study date
6 December 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248100
Title
Report AT002-FPK-17-011 part b - PK study
Study date
6 December 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248101
Title
Report AT002-FPK-17-011 part c - PK study
Study date
6 December 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248102
Title
Report AT002-FPK-17-011 part d - PK study
Study date
6 December 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248103
Title
Report AT002-FPK-17-011 part e - PK study
Study date
6 December 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248104
Title
Report ELAVV200123 Efficacy
Study date
29 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248105
Title
Report ELAVV200258 Efficacy
Study date
7 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248106
Title
Report AT002-FAN-12-001 Method determination study
Study date
23 March 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248107
Title
Report VARAT1700E1 dose determination
Study date
September 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248108
Title
Report AT002-FTX-14-001 Pilot safety study
Study date
3 December 2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248109
Title
Changes in renal sympathetic nerve activity, heart rate and arterial blood pressure associated with eating in cats.
Study date
1987
Auth party contact address
-
Data no
248110
Title
Report DM1999-424391-031 Efficacy
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248118
Title
Target animal safety summary
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248119
Title
Report 7481R-60-02-250 - Safety
Study date
7 November 2003
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248120
Title
Report AT002-FTX-14-001 Safety
Study date
3 December 2014
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248121
Title
Report AT002-FTX-16-002 Pivotal safety
Study date
3 July 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248122
Title
Report AT002-FTX-19-003 safety
Study date
19 December 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248179
Title
Environmental risk assessment
Study date
19 November 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
275765
Title
Appendix 2-49 - apvma communication
Study date
3/7/2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
276480
Title
Response to S159 notice
Study date
6/10/2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248052
Title
Study Report DM1995-424391-002 - PK study
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248053
Title
Study Report DM1996-424391-007 - metabolism
Study date
31 January 1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248054
Title
Study Report DM1997-424391-019-metabolism
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248056
Title
Study Report DM1998-424391-020 Metabolism
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248058
Title
Study Report DM1998-424391-022 PK study
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248059
Title
Study Report DM1999-424391-029 Metabolism
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248061
Title
Study Report DM1999-424391-033 Distribution
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248060
Title
Study Report DM1999-424391-030 Metabolism
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248057
Title
Study Report DM1998-424391-021 Metabolism
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248055
Title
Study Report DM1998-424391-018 PK study
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248171
Title
Applicant overview OHS
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248172
Title
Applicants summary - ID of product
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248174
Title
Safety data sheets
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248175
Title
Effects of an oral growth hormone secretagogue in older adults
Study date
2009
Auth party contact address
-
Data no
248176
Title
Pharmacokinetics of the ghrelin agonist capromorelin in a single ascending dose Phase-1 safety trial in spinal cord-injured and able-bodied volunteers.
Study date
2015
Auth party contact address
-
Data no
248177
Title
Effect of single doses of Capromorelin and Ghrelin on Esophageal Reflux Parameters and Esophageal Function: A Randomized, Double-Blind, Placebo-Controlled study.
Study date
2022
Auth party contact address
-
Data no
248173
Title
Applicants summary - User Risk Assessment
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248138
Title
Study Report 97-1340-14 - Dermal/Ocular study
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248074
Title
Study Report 96-1340-12 - oral toxicity
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248130
Title
Study Report 99-1340-28 Reproductive study
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248067
Title
Study Report DM1999-424391-027 toxicokinetics
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248068
Title
Study Report DM1999-424391-028 Toxicokinetics
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248132
Title
Study Report 99-1340-29 Reproductive study
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248137
Title
Other Safety Summary
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248178
Title
Part 3 Toxicology overview
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248069
Title
Report DM1996-424391-009 method validation
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248070
Title
Toxicology summary
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248071
Title
Study Report 96-1340-02 - toxicity
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248131
Title
Study Report 98-1340-27 Range finding study
Study date
19 October 99
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248140
Title
Effects of an oral growth hormone secretagogue in older adults.
Study date
2009
Auth party contact address
-
Data no
248141
Title
Pharmacokinetics of the ghrelin agonist capromorelin in a single ascending dose Phase-I safety trial in spinal cord-injured and able-bodied volunteers.
Study date
2015
Auth party contact address
-
Data no
248142
Title
Effect of Single Doses of Capromorelin and Ghrelin On Esophageal Reflux Parameters and Esophageal Function: A Randomized, Double-Blind, Placebo-Controlled Study.
Study date
2009
Auth party contact address
-
Data no
248123
Title
Summary ID of product
Study date
November 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248124
Title
Study Report 99030 (part 1 of 2) - oral toxicity
Study date
8 February 2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248125
Title
Study Report 99030 (part 2 of 2) - oral toxicity
Study date
8 February 2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248126
Title
Study Report 99094 - 3m toxicity
Study date
20 October 2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248075
Title
Study Report 99030 (part 1 of 2) - oral toxicity
Study date
8 February 2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138132
Product/Active constituent Name
Application Product Name
Capromorelin/Capromorelin Tartrate
Application Date
Application Number
138132
Application Product Name
Capromorelin/Capromorelin Tartrate
Application details
Product name:
Capromorelin/Capromorelin Tartrate
Product number:
93159
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
This application is to apply for the registration of Capromorelin Oral Solution for Cats which contains 20 mg/mL of capromorelin tartrate. Approval of the API will be undertaken concurrently with this application.
The proposed indication is for body weight gain in cats experiencing poor appetite or unintended weight loss resulting from chronic medical conditions.
The recommended dose is 2 mg/kg body weight (equivalent to 0.1 mL/kg of the final solution), once daily.
Description of data provided:
Data no
248194
Title
API Analytical procedures
Study date
16 December 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
249994
Title
Certificate of Analysis 123295
Study date
April 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
249995
Title
Certificate of Analysis 0000124051
Study date
May 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
249996
Title
Certificate of Analysis 2049500-0000108409
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248196
Title
API Batch analysis
Study date
12 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248192
Title
API manufacturing
Study date
15 December 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248193
Title
API control critical steps
Study date
9 March 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283187
Title
Ref 3 - Manufacturing process development (API)
Study date
2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283190
Title
Ref 1 - Control of materials (API)
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283191
Title
Ref 2 - Control of critical steps and intermediates (API)
Study date
2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283192
Title
Elanco S159 response
Study date
3/2/2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248195
Title
API reference standards
Study date
12 January 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283188
Title
Ref 4 - Impurities (API)
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283189
Title
Ref 5 - Specification (API)
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248189
Title
API elucidation & other characteristics
Study date
13 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248190
Title
API general properties
Study date
29 October 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248191
Title
API justification specification
Study date
7 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248197
Title
API container closure system
Study date
7 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248198
Title
API stability summary
Study date
13 April 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248199
Title
Study Report 96-1340-03 Genetic toxicology study
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248200
Title
Study Report 96-1340-04 Genetic toxicology study
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248201
Title
Study Report 96-1340-10 Genetic toxicology study
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248202
Title
Study Report 96-1340-11 Genetic toxicology study
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248203
Title
Study Report DM1996-424391-001 toxicokinetics
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248204
Title
Study Report DM1996-424391-003 Toxicokinetics
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248205
Title
Study Report DM1996-424391-004 toxicokinetics
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248206
Title
Study Report DM1997-424391-012 toxicokinetics
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248207
Title
Study Report DM1997-424391-015 Toxicokinetics
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248182
Title
Study Report 96-1340-06 - dose escalation
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248183
Title
Study Report 96-1340-07 - oral toxicity
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248184
Title
Study Report 96-1340-08 Oral toxicity
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248185
Title
Study Report 96-1340-13 Oral toxicity
Study date
8 June 1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248186
Title
Study Report 98-1340-24 Oral range finding
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248188
Title
Report 96-1340-13 oral toxicity
Study date
8 June 1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248187
Title
Study Report 97-1340-15 Skin sensitization
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138784
Product/Active constituent Name
Application Product Name
4FARMERS MetAzoxy Fungicide
Application Date
Application Number
138784
Application Product Name
4FARMERS MetAzoxy Fungicide
Application details
Product name:
4FARMERS MetAzoxy Fungicide
Product number:
93355
Applicant Name:
4 FARMERS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 124g/L Metalaxyl-M+ 322g/L Azoxystrobin SE
for the control of Rhizoctonia, Pythium, Leaf Rust and Net Blotch in Barley, control of Rhzoctonia, Pythium and Stripe Rust in Wheat, and suppression of Powdery Mildew in Barley and Yellow Spot in Wheat, as per teh Directions for Use.
Reference details:
69673 - UNIFORM FUNGICIDE
Active constituents:
Active constituent name
66812 - AZOXYSTROBIN
Active constituent name
81437 - Metalaxyl-M
Description of data provided:
Data no
250486
Title
QCM=050-Azoxystrobin and Metalaxyl-M in TGAC and formulated products by HBLC
Study date
13.10.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
250487
Title
Validation of method QCM-050 for the assay of Azoxystrobin and Metalaxyl-m
Study date
07.11.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
262478
Title
Validation of method QCM-050 for the assay of Azoxystrobin and Metalaxyl-M
Study date
07.11.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
262481
Title
QCM-050-Azoxystrobin and Metalaxyl-M in TGAC and Formulated products by HPLC
Study date
13.10.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
250484
Title
PART 2 Chemistry and Manufacture
Study date
21.11.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
262477
Title
CHEMISTRY AND MANUFACTURE
Study date
21.11.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
250485
Title
Stability Data
Study date
02.11.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267643
Title
4Farmers Metazoxy -Chromatogram
Study date
2024
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267645
Title
Metalaxyl-M -Chromatogram
Study date
2024
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267646
Title
Azoxystrobin -Chromatogram
Study date
2024
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267644
Title
Metalaxyl-M for the control of Rhizoctonia in Spring Barley-York , WA
Study date
April 2021
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267640
Title
4Farmers Barley Fungicide - Metalaxyl- M & Azoxystrobin Trial Report
Study date
Sep 2020
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267641
Title
Metalaxyl-M for the control of Rhizoctonia in Spring Barley-Grace Valley WA
Study date
April 2021
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
267642
Title
4Farmers Wheat Fungicide - Metalaxyl- M & Azoxystrobin Trial Report
Study date
Sep 2020
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
262479
Title
Safety Data Sheets (SDSs) for Components
Study date
31.08.22
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
262480
Title
Certificate Analysis of Azoxystrobin and Metalaxyl-M TGAC
Study date
2023
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
250488
Title
Safety Data Sheets (SDSs ) for components
Study date
2023
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
250489
Title
Appendix 2.5
Study date
2023
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date
Application Date
Application No
Application Number
138742
Product/Active constituent Name
Application Product Name
Abamectin
Application Date
Application Number
138742
Application Product Name
Abamectin
Application details
Product name:
Abamectin
Active name:
Abamectin
Applicant Name:
PULLULO PHARM PTY LTD
Description of data provided:
Data no
250275
Title
Certificate of Analysis
Study date
29/06/22
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
267284
Title
Veterinary master file
Study date
2024
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
262098
Title
Active identification data
Study date
17/11/2023
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
262099
Title
Active specifications and manufacturing
Study date
17/11/2023
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
262100
Title
Analytical procedures
Study date
17/11/2023
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
262101
Title
Analytical- Impurity identification data
Study date
17/11/2023
Auth party contact address
6 Whycombe Road Terrigal Australia
Date
Application Date
Application No
Application Number
138744
Product/Active constituent Name
Application Product Name
Closantel
Application Date
Application Number
138744
Application Product Name
Closantel
Application details
Product name:
Closantel
Active name:
Closantel
Applicant Name:
PULLULO PHARM PTY LTD
Application purpose and description of use:
Application for the approval of new source closantel without a monograph in a combined product application (138279)
Description of data provided:
Data no
250277
Title
Certificate of Analysis
Study date
31/05/2022
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
262042
Title
Manufacturing Data
Study date
August 2011
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
267637
Title
Additional Information for Closantel - NMR and MS data
Study date
August 2019
Auth party contact address
6 Whycombe Road Terrigal Australia
Data no
281464
Title
Active Substance Master File for Closantel
Study date
29/11/2024
Auth party contact address
6 Whycombe Road Terrigal Australia
Date
Application Date
Application No
Application Number
138462
Product/Active constituent Name
Application Product Name
Kanemite Miticide
Application Date
Application Number
138462
Application Product Name
Kanemite Miticide
Application details
Product name:
Kanemite Miticide
Product number:
88076
Applicant Name:
ARYSTA LIFESCIENCE AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend label to include use in tomatoes and capsicums.
Active constituents:
Active constituent name
88075 - Acequinocyl
Description of data provided:
Data no
249603
Title
Comparison of I2017aa 156 SC with Acramite 480 SC for the Control of Two-Spotted Mite (Tetranychus urticae) in Tomatoes cv. Duncan
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249604
Title
Trial Report #1. Two Spotted Mite ??? Tomatoes. Determine the efficacy and Crop Safety of 12017aa Miticide in Tomatoes
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249605
Title
Trial Report #2. Two Spotted Mite ??? Tomatoes Determine the Efficacy and Crop Safety of 12017aa Miticide in Tomatoes
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249606
Title
Two Spotted Mite ??? Tomatoes Determine the Efficacy and Crop Safety of 12017aa Miticide in Tomatoes.
Study date
2021
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249607
Title
I2017aa Efficacy and Crop Safety for TSM Control in Tomatoes
Study date
2021
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249608
Title
Determination of the Efficacy and Crop Safety of I2017aa when Applied to Capsicum to Control Mites
Study date
2019
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249609
Title
Comparison of I2017aa 156 SC with Acramite 480 SC for the Control of Two-Spotted Mite (Tetranychus urticae) in Chilli cv. Caysan
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249610
Title
Determination of the Efficacy and Crop Safety of I2017aa when Applied to Capsicum to Control Mites
Study date
2022
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
258925
Title
Trials to determine the efficacy and crop safety of I2017aa for the control of Two spotted mite in tomato - supplementary ANOVA data
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
258926
Title
Comparison of I2017aa 156 SC with Acramite 480 SC for the control of twospotted mite (Tetranychus urticae) in chilli cv. Caysan - supplementary ANOVA data
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249602
Title
Part 8: Efficacy and Safety Dossier
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249584
Title
Kanemite Miticide - Proposed Label
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249585
Title
Kanemite Miticide Safety Data Sheet
Study date
2021
Auth party contact address
-
Data no
249586
Title
Aceqiunocyl Technical Safety Data Sheet
Study date
2018
Auth party contact address
-
Data no
249588
Title
Kanemite 15SC label_US
Study date
2023
Auth party contact address
-
Data no
249589
Title
Shuttle 15SC Miticide Acaricide label_Canada
Study date
2023
Auth party contact address
-
Data no
249587
Title
Public Release Summary on the evaluation of the new active constituent acequinocyl in the product Kanemite Miticide APVMA product number 88075
Study date
2020
Auth party contact address
-
Data no
249597
Title
Part 6: Work Health and Safety Dossier
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249598
Title
Acequinocyl 150 SC OPEX for Tomato-Pepper Australia
Study date
2022
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249592
Title
Determination of residues of Acequinocyl in tomatoes and capsicums following a single foliar application of I2017aa
Study date
2022
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249593
Title
Determination of residues of Acequinocyl in tomatoes and capsicums following a single foliar application of I2017aa (Kanemite)
Study date
2022
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249590
Title
Part 5A: Residues Dossier
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
258924
Title
A Confined Rotational Crop Study with 14C-Acequinocyl
Study date
2007
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249591
Title
Part 5B: Overseas Trade Dossier
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249594
Title
Australian Horticulture Statistics Handbook 2020/21 Vegetables
Study date
2021
Auth party contact address
-
Data no
249595
Title
OECD Calculator - Capsicum
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249596
Title
OECD Calculator - Tomatoes
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249599
Title
Part 7: Environment Dossier
Study date
2023
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249600
Title
Environmental Technical Report
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Data no
249601
Title
Evaluation and Assessment Report in Relation to an Application for Approval of a NEW Active Constituent
Study date
2020
Auth party contact address
LEVEL 3 70 Hindmarsh Square ADELAIDE Australia
Date
Application Date
Application No
Application Number
138156
Product/Active constituent Name
Application Product Name
TAEGRO Fungicide
Application Date
Application Number
138156
Application Product Name
TAEGRO Fungicide
Application details
Product name:
TAEGRO Fungicide
Product number:
93175
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 130 g/kg Bacillus amyloliquefaciens strain FZB24 wettable powder product for disease control in grapes, in conjunction with approval of Bacillus amyloliquefaciens strain FZB24.
Description of data provided:
Data no
248406
Title
Taegro Flammability (Solids)
Study date
2013
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248397
Title
Salem Cleaning and Sanitisation Procedure
Study date
2021
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248390
Title
Composition Taegro Technical and Quality Specifications for Taegro Technical
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248398
Title
DNA-DNA hybridisation values and their relationship to whole-genome sequence similarities
Study date
2007
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248399
Title
Genomic insights that advance the species definition for prokaryotes
Study date
2004
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248400
Title
High throughput ANI analysis of 90K prokaryotic genomes reveals clear species boundaries
Study date
2018
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248401
Title
Relationship of Bacillus amyloliquefaciens clades associated with strains DSM 7T and FZB42T: a proposal for Bacillus amyloliquefaciens subsp. amyloliquefaciens subsp. nov. and Bacillus amyloliquefaciens subsp. plantarum subsp. nov. based on complete genome sequence comparisons
Study date
2011
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248402
Title
Taxonomic placement of the Bacillus strain FZB24 in Taegro
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248388
Title
Taegro Technical Product Chemistry
Study date
2012
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248392
Title
Multi-locus sequence analysis (MLSA) of Bacillus subtilis var. amyloliquefaciens strain FZB24, the active ingredient in Taegro
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248393
Title
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedures - International Form
Study date
2009
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248394
Title
Bacillus velezensis is not a later heterotypic synonym of Bacillus amyloliquefaciens; Bacillus methylotrophicus, Bacillus amyloliquefaciens subsp. plantarum and ???Bacillus oryzicola??? are later heterotypic synonyms of Bacillus velezensis based on phylogenomics
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248395
Title
Bacillus velezensis sp. nov., a surfactant-producing bacterium isolated from the river Velez in Malaga, southern Spain
Study date
2005
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248396
Title
Certificate of Analysis - Taegro Technical 2
Study date
2021
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248389
Title
Final Storage Stability Study for Taegro Technical (70127-6)
Study date
2012
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248404
Title
Draft Assessment Report Bacillus amyloliquefaciens strain FZB24 Volume 3 Annex B5 Analytical methods
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248413
Title
Spore Count Procedure for Taegro
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248414
Title
Contamination Detection of Yeast and Moulds in Taegro and Taegro Technical
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248415
Title
Gram Negative Contamination Detection in Taegro and Taegro Technical
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248416
Title
Vibrio spp. Contamination Detection in Taegro and Taegro Technical
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248417
Title
Shigella Contamination Detection in Taegro and Taegro Technical
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248419
Title
Contamination Detection of E. coli and Coliforms using MPN
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248428
Title
Registration Report Part B Section 2 Analytical methods
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248418
Title
Salmonella Detection using VIDAS?? SPT in Taegro and Taegro Technical
Study date
2019
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248412
Title
Certificate of Analysis - Taegro EUP
Study date
2020
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248405
Title
Taegro 2 Product Chemistry
Study date
2014
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248411
Title
Composition Taegro and Quality Specifications for Taegro
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248407
Title
Taegro (A-B) Manufacturing Process
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248408
Title
Taegro (B) Manufacturing Process
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248387
Title
Part 2 - Chemistry and Manufacture
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
248410
Title
Safety Data Sheets
Study date
2022
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248421
Title
Draft Assessment Report Volume 4 Annex C Confidential Information
Study date
2015
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248422
Title
Draft Assessment Report Volume 1
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248423
Title
Draft Assessment Report Volume 2 Annex A Lists of tests and studies submitted and of information available
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248424
Title
Draft Assessment Report Volume 3 Annex B3 Data application and further information
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248425
Title
Registration Report Part A Risk Management
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248426
Title
Registration Report Part B Section 1: Identity, biological, physical and chemical properties, other information GH uses
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248427
Title
Registration Report Part B Section 1: Identity, biological, physical and chemical properties, other information field uses
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248391
Title
Draft Assessment Report Bacillus amyloliquefaciens strain FZB24 Volume 3 Annex B1 Identity
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248403
Title
Draft Assessment Report Bacillus amyloliquefaciens strain FZB24 Volume 3 Annex B2 Biological, physical, chemical and technical properties
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248430
Title
Registration Report Part C Confidential Information
Study date
2016
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248429
Title
Storage Stability for Taegro (PCP#30720)
Study date
2014
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248420
Title
Taegro Storage Stability
Study date
2015
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
248409
Title
Taegro Accelerated Storage Stability
Study date
2013
Auth party contact address
5400 Corporate Circle, Salem, Virginia, 24153, USA
Data no
264373
Title
Efficacy of biorational products in grapevines for control of powdery mildew
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264374
Title
Evaluation of biorational products for the control of powdery mildew (Erysiphe necator) in grapevines cv. Verdelho
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264375
Title
Efficacy of biorational products in grapevines for control of botrytis
Study date
2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264376
Title
Efficacy of biorational products in grapevines for control of botrytis
Study date
2020
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264377
Title
Efficacy of biorational products in grapevines for control of powdery mildew
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264378
Title
Efficacy of biorational products in grapevines for control of powdery mildew
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264379
Title
Efficacy of biorational products in grapevines for control of powdery mildew
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264380
Title
Efficacy of Taegro WP, applied curatively for control of Botrytis bunch rot (Botrytis cinerea) in grapevines cv. Sauvignon Blanc
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264381
Title
Efficacy of Syngenta products for control of a range of viticultural diseases in grapevines cv. Sauvignon Blanc
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264382
Title
Demonstration of new pipeline products in grapevines cv. Merlot
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264383
Title
Efficacy of biorational products in grapevines for control of botrytis
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264384
Title
Evaluation of TAEGRO in GRAPEVINES for control of BOTRYTIS
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264385
Title
Evaluation of TAEGRO in GRAPEVINES for control of BOTRYTIS
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264386
Title
Evaluation of TAEGRO in GRAPEVINES for control of Powdery mildew
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264387
Title
Evaluation of TAEGRO in GRAPEVINES for control of Powdery mildew
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264371
Title
Part 8 - Efficacy & Crop Safety
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254115
Title
Bacillus subtilis var. amyloliquefaciens: A Five-Concentration Toxicity and Pathogenicity Test with the Rainbow Trout (Oncorhynchus mykiss)
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254116
Title
Bacillus subtilis var. amyloliquefaciens: A 21-Day Life-Cycle Toxicity and Pathogenicity Test with the Cladoceran (Daphnia magna)
Study date
1999
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254117
Title
Algae Growth Inhibition Test ? Test Article: Bacillus subtilis Strain FZB24
Study date
1994
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254118
Title
Evaluation of the Dietary Effect(s) of Bacillus subtilis var. amyloliquefaciens on Adult Honey Bees (Apis mellifera L.)
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254119
Title
Evaluation of the Dietary Effect(s) of Bacillus subtilis var. amyloliquefaciens on Honey Bee Larvae (Apis mellifera L.)
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254123
Title
Bacillus subtilis var. amyloliquefaciens strain FZB24: An Acute Toxicity Study with the Earthworm in an Artificial Soil Substrate
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254120
Title
Parasitic Wasp, Aphidius matricariae, Non-Target Insect Microbial Testing
Study date
2011
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254121
Title
Ladybird Beetle Non-Target Insect Microbial Testing
Study date
2011
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254122
Title
Green Lacewing Non-Target Insect Microbial Testing
Study date
2011
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254124
Title
Assessment of the Effects of the Product TAEGRO Technical on Soil Microorganisms Respiration and Nitrification
Study date
2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254125
Title
Bacillus DNA in Fossil Bees: an Ancient Symbiosis?
Study date
1994
Auth party contact address
-
Data no
254126
Title
Bacteria Belonging to the Genus Bacillus Isolated from Honey Bees, Apis mellifera, Fed 2,4-D and Antibiotics (1)
Study date
1978
Auth party contact address
-
Data no
254127
Title
Anaerobic Bacteria Isolated from the Alimentary Canals of Alfalfa Leaf Cutting Bee Larvae
Study date
1998
Auth party contact address
-
Data no
254128
Title
Diversity of Microflora in the Gut and Casts of Tropical Composting Earthworms Reared on Different Substrates
Study date
2007
Auth party contact address
-
Data no
254104
Title
Effects of Chemical Control Agents and Microbial Biocontrol Agents on Numbers of Non-Target Microbial Soil Organisms: A Meta-Analysis
Study date
2011
Auth party contact address
-
Data no
254105
Title
Acute Oral and Contact Effects of TAEGRO to adult worker honeybees Apis mellifera L. Laboratory Test
Study date
2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254106
Title
Draft Assessment Report, B. amyloliquefaciens strain FZB24, Volume 3 Annex B.9, Effects on Non-Target Organisms
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254114
Title
Bacillus subtilis var. amyloliquefaciens: An Avian Oral Pathogenicity and Toxicity Study in the Northern Bobwhite
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264372
Title
Overview - Stage D Submission
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
264370
Title
TAEGRO draft label
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254107
Title
TAEGRO - draft label - 24 May 2023
Study date
24 May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
248385
Title
PAA2-135691 - TAEGRO Fungicide - Project Plan signed
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
248386
Title
TAEGRO label
Study date
2022
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
279059
Title
Part 6 - A20570A Work Health & Safety
Study date
May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
250954
Title
Registration Report Part B Section 4: Metabolism and Residues, Detailed Summary of the Risk Assessment
Study date
Dec 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
250955
Title
DAR Volume 3 Annex B.7 Residue data
Study date
Feb 2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
250956
Title
Part 5A - Residues
Study date
Mar 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254080
Title
Acute Dermal Toxicity Study in of Taegro Technical in Rats
Study date
2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254085
Title
Acute Dermal Irritation/Corrosion Test of Taegro Technical in Rabbits
Study date
1994
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254086
Title
Acute Dermal Irritation Study of Taegro Technical in Rabbits
Study date
2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254087
Title
Dermal Sensitisation Study of B. amyloliquefaciens strain FZB24 in Guinea Pigs Using the Buehler Method
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254093
Title
Acute Dermal Toxicity Study of Taegro-2 in Rats
Study date
2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254094
Title
Acute Dermal Toxicity/Pathology Study of B. amyloliquefaciens strain FZB24, WDG End Use Product in Rabbits
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254098
Title
Acute Dermal Irritation Study of Taegro-2 in Rabbits
Study date
2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254083
Title
Acute Eye Irritation Study in Rabbits
Study date
2017
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254096
Title
Acute Eye Irritation Study of Taegro-2 in Rabbits
Study date
2013
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254097
Title
Primary Eye Irritation Study of B. amyloliquefaciens strain FZB24 WDG End Use Product in Rabbits
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254082
Title
Toxicity/Pathogenicity Testing of B. amyloliquefaciens strain FZB24 Following Acute Intratracheal Challenge in Rats
Study date
1999
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254095
Title
Acute Inhalation Toxicity Study (Limit Test) of B. amyloliquefaciens strain FZB24 WDG End Use Product in Rats
Study date
1999
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254084
Title
Primary Eye Irritation Study of B. amyloliquefaciens strain FZB24 in Rabbits
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254081
Title
Acute Dermal Toxicity/Pathology Study in of B. amyloliquefaciens strain FZB24 in Rabbits
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254088
Title
Toxicity/Pathogenicity Testing of B. amyloliquefaciens strain FZB24 following Acute Intravenous Challenge in Rats
Study date
1999
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254078
Title
Acute Oral Toxicity/Pathogenicity Study of Taegro Technical in Mice
Study date
2014
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254079
Title
Toxicity/Pathogenicity Testing of B. amyloliquefaciens strain FZB24 Following Acute Oral Challenge in Rats
Study date
1998
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254100
Title
Assessment of Potential Change in Toxicological Profile of B. amyloliquefaciens strain FZB24 Spores Due to Change in Fermentation Process
Study date
2021
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254092
Title
Acute Oral Toxicity/Pathogenicity Study of Taegro 2 in Mice
Study date
2014
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254099
Title
Taegro ? Hypersensitivity Incidents
Study date
2012
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254089
Title
Introduction of a Qualified Presumption of Safety (QPS) Approach for Assessment of Selected Microorganisms Referred to EFSA
Study date
2007
Auth party contact address
-
Data no
254090
Title
Scientific Opinion on the Maintenance of the List of QPS Biological Agents Intentionally Added to Food and Feed (2012 update)
Study date
2012
Auth party contact address
-
Data no
254091
Title
Literature Review on B. amyloliquefaciens strain FZB24 and Metabolites: Effects on Human Health
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254101
Title
Draft Assessment Report, B. amyloliquefaciens strain FZB24 Volume 3 Annex B.6 Effects on Human Health
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254102
Title
Toxicological Database ? B. amyloliquefaciens strain FZB24
Study date
2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
279058
Title
Part 3 - Toxicology
Study date
May 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254103
Title
Use of Bacillus subtilis as biocontrol agent. I. Activities and characterisation of Bacillus subtilis strains
Study date
1998
Auth party contact address
-
Data no
254108
Title
Effects of B. amyloliquefaciens strain FZB24 on lettuce growth and health under pathogen pressure and its impact on the rhizosphere bacterial community
Study date
2014
Auth party contact address
-
Data no
254109
Title
Effect of the strain B. amyloliquefaciens strain FZB24 on the microbial community in the rhizosphere of lettuce under field conditions analysed by whole metagenome sequencing
Study date
2014
Auth party contact address
-
Data no
254110
Title
Environmental persistence of Bacillus anthracis and Bacillus subtilis spores
Study date
2015
Auth party contact address
-
Data no
254111
Title
Literature review on B. amyloliquefaciens strain FZB24 and metabolites: fate and behaviour in the environment
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
254112
Title
The iturin and fengycin families of lipopeptides are key factors in antagonism of Bacillus subtilis toward Podosphaera fusca
Study date
2006
Auth party contact address
-
Data no
254113
Title
Draft assessment report, B. amyloliquefaciens strain FZB24, Volume 3 Annex B.8 Fate and behaviour in the environment
Study date
2016
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138134
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Enteritidis
Application Date
Application Number
138134
Application Product Name
Salmonella Enterica ser. Enteritidis
Application details
Product name:
Salmonella Enterica ser. Enteritidis
Product number:
93161
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138136
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Typhimurium
Application Date
Application Number
138136
Application Product Name
Salmonella Enterica ser. Typhimurium
Application details
Product name:
Salmonella Enterica ser. Typhimurium
Product number:
93163
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.