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
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
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
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
248195
Title
API reference standards
Study date
12 January 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
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
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
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 for 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.
Date
Application Date
Application No
Application Number
138142
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application Date
Application Number
138142
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application details
Product name:
AviPro Salmonella Vac E Live Vaccine
Product number:
93166
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction
with approval of an active constituent.
Description of data provided:
Data no
248705
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248706
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248711
Title
Master seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248712
Title
Working seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248714
Title
Batch to batch consistency
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248715
Title
Batch record-5062300
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248716
Title
Batch record-A059400
Study date
09 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248717
Title
Batch record-A059500
Study date
10 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248718
Title
Batch record-G033600
Study date
29 November 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248707
Title
Validation report 0-0063-vr-110-01-01
Study date
21 March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248708
Title
Validation report 0-0060-vr-ba01
Study date
03 Jan 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248709
Title
Validation report 0-0060-vr-91998-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248710
Title
Starting materials of biological origin
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248713
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261822
Title
Batch record Salm VacE
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261823
Title
Residual moisture VR Salm VacE
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248704
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248701
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248702
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248703
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248719
Title
Stability overview and conclusion
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248720
Title
Long term stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248721
Title
Relocation stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248722
Title
In-use stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248723
Title
Stress stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248724
Title
Batch record-6093500
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248725
Title
Batch record-6093700
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248726
Title
Appendix 8-0 Part 8 overview Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248699
Title
Appendix 1-0 Part 1 overview AviPro Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248700
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138146
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application Date
Application Number
138146
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application details
Product name:
AviPro Salmonella Vac T Live Vaccine
Product number:
93168
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of an active constituent (secondary application).
Description of data provided:
Data no
248674
Title
Master seed S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248675
Title
Working see S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248677
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248678
Title
Batch record-6005400
Study date
26 April 2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248679
Title
Batch record-9101100
Study date
9 May 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248680
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248681
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248682
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248676
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261824
Title
Residual moisture VR Salm VacT
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261825
Title
Batch-record Salm VacT
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248667
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248668
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248669
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248670
Title
Validation report 0-0060-vr-92059-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248671
Title
Validation report 0-0060-vr-ba01
Study date
03 January 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248672
Title
Validation report 0-0063-vr-111-01
Study date
29 March 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248673
Title
Starting materials of biological origin
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248664
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248665
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248666
Title
Product development
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248683
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248684
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248685
Title
Intermediate storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248686
Title
In-use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248687
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248688
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248689
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248690
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248691
Title
Batch record-5076600
Study date
1 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248692
Title
Batch record-5076800
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248693
Title
Batch record-5077000
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248694
Title
Part 8 overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248662
Title
Part 1 application overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248663
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138135
Product/Active constituent Name
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application Date
Application Number
138135
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application details
Product name:
AviPro Salmonella Duo Live Vaccine
Product number:
93162
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.
Description of data provided:
Data no
248208
Title
Master seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248209
Title
Master seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248210
Title
Working seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248211
Title
Working seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261796
Title
Salmonella Enteritidis WSB _ CoA
Study date
11 December 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261797
Title
Salmonella Typhimurium WSB _ CoA
Study date
14 April 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248212
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248213
Title
Development of S.E. strain
Study date
March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248214
Title
Development of S.T. strain
Study date
May 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248215
Title
Expert report
Study date
16 December 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248216
Title
0-0115-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248217
Title
0-0061-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248218
Title
0-0062-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248219
Title
0-0060-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248220
Title
0-0063-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248221
Title
0-0110-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248222
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248223
Title
Batch record-200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248224
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248225
Title
Batch record-b052600-03
Study date
13 February 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248226
Title
Batch record-g039700-01
Study date
29 December 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248227
Title
GMP certificate
Study date
15 November 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248228
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248229
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248230
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248231
Title
Validation report 0-0063-VR-111-01
Study date
23 November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248232
Title
Validation report 0-0060-VR-92637
Study date
04 May 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248233
Title
Starting materials listed in pharmacopoeias
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248234
Title
Starting materials of non-biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248235
Title
Starting materials of biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248236
Title
In process control tests
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248237
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261798
Title
Specification vial
Study date
5 January 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261799
Title
Specification stopper
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261800
Title
Specification cap
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261801
Title
Batch-record Salm Duo
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261802
Title
Filling-closing procedure
Study date
30 September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261803
Title
Sealing procedure
Study date
30 May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261804
Title
Homogenous mixing
Study date
20 August 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261805
Title
Residual moisture VR Salm Duo
Study date
November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261806
Title
Protocol vials and stoppers
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261807
Title
Chem & Manuf response to s159(1)(a) Notice of 25 July 2023
Study date
October 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248238
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248239
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248240
Title
Vial
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248241
Title
Quality Certificate
Study date
October 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248242
Title
Closure
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248243
Title
Quality Certificate
Study date
November 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248244
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248245
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248246
Title
Frozen storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248247
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248248
Title
Relocation stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248249
Title
In use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248250
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248251
Title
Batch record 200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248252
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248253
Title
Batch record-200401-3c
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248254
Title
Batch record-9475400
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248255
Title
Study no.: 85/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248256
Title
Study no.: 262/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248257
Title
Study no.: 278/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248258
Title
Study no.: 147/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248259
Title
Study no.: 148/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248260
Title
Study no.: 147/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248261
Title
Study no.: 13/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248262
Title
Study no.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248263
Title
Study no.: 485/99
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248264
Title
Study no.: 372/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248265
Title
Study no.: 152/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248266
Title
Study no.: 250/93
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248267
Title
Study no.: 60/96
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248268
Title
M. Voss, 1996 (Study: Lohmann Information 3/96)
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248269
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261808
Title
Study No. 92/92
Study date
19 June 1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261809
Title
SPF-certification relating to Study 85/01
Study date
7 March 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261810
Title
Wird die Wirksamkeit der Immunisierung von K ? ken mit Salmonella-Lebendimpfstoffen durch maternale Anik?rper beeinflusst?
Study date
2002
Auth party contact address
-
Data no
261811
Title
Successful vaccination of layer pullets during the first days of life using a bivalent live vaccine against Salmonella Enteritidis and Salmonella Typhimurium
Study date
September 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261812
Title
Impact of maternal antibodies on the efficacy of immunisation of chicks with live Salmonella vaccines
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278659
Title
Expert Report 4/6/2024
Study date
4 June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270314
Title
Response App 2-12 G-A
Study date
20 March 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270315
Title
Ph. Eur. 2520E
Study date
2013
Auth party contact address
-
Data no
270316
Title
Ph. Eur. 2521E
Study date
2013
Auth party contact address
-
Data no
261813
Title
Safety & Efficacy response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248270
Title
Part 8 Overview AviPro Salmonella Duo
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248271
Title
Expert report on the possible transferability of plasmids between cells of Salmonella VacE and Salmonella VacT during co-cultivation
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248272
Title
PDV/5101-ER/2011-05-04
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248273
Title
Study no.: 37/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248274
Title
Study no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248275
Title
Study no.: 279/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248276
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248277
Title
Study no.: Salmonella 101
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248278
Title
Study no.: LAH2001-1
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248279
Title
Study no.: 188/11
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248280
Title
Study no.: V2011/07
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248281
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248282
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248283
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248284
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248285
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248286
Title
Study: Hannover Veterinary College (Expert report on the safety of a Salmonella vaccine strain for calves and piglets)
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248287
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248288
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac E.
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248289
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248290
Title
Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248291
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248292
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248293
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248294
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella Typhimuriumisolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248295
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248296
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248297
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248298
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248299
Title
Infection model of Salmonella Enteritidis and S. Typhimurium in Pekin ducks (Anas playrhynchos)
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248300
Title
Salmonella infection in a commercial line of ducks; Experimental studies on virulence, intestinal colonization and immune protection
Study date
1999
Auth party contact address
-
Data no
248301
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248302
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248303
Title
Duck-Tec Bruterei GmbH (Administration of AviPro Salmonella Vac E and AviPro Salmonella Vac T to Peking ducks under field conditions
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248304
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248305
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261814
Title
Vaccines for Veterinary Use (Supplement 7.7)
Study date
September 2021
Auth party contact address
-
Data no
261815
Title
Testing Standard 0-0171-TS-BA.01
Study date
20 January 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261816
Title
5.2.6. Evaluation of Safety of Veterinary Vaccines and Immunosera
Study date
04/2024
Auth party contact address
-
Data no
261817
Title
Monograph 2520
Study date
04/2013
Auth party contact address
-
Data no
261818
Title
Monograph 2521
Study date
04/2013
Auth party contact address
-
Data no
248325
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270317
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac T Live Vaccine
Study date
24 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270318
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac E Live Vaccine
Study date
25 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270319
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Duo Live Vaccine
Study date
30 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254979
Title
Common themes among bacteriophage-encoded virulence factors and diversity among the bacteriophages involved.
Study date
2002
Auth party contact address
-
Data no
254980
Title
Vaccination against Salmonella Enteritidis in Dutch commercial layer flocks with a vaccine based on a live Salmonella Gallinarum 9R strain: evaluation of efficacy, safety, and performance of serologic Salmonella tests.
Study date
2001
Auth party contact address
-
Data no
254981
Title
Development of live Salmonella vaccines optimally attenuated for chickens.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254982
Title
Minireview: Antibiotic-supersusceptible mutants of Escherichia coli and Salmonella Typhimurium.
Study date
1993
Auth party contact address
-
Data no
254983
Title
Alterations in outer membrane permeability.
Study date
1984
Auth party contact address
-
Data no
254984
Title
Stable Salmonella live vaccine strains with two or more attenuating mutations and any desired level of attenuation
Study date
1990
Auth party contact address
-
Data no
270320
Title
20240411 Cover letter Salmonella vaccines
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270321
Title
20240411 Response doc-April 2024
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270322
Title
138135-93162 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270323
Title
138146-93168 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270324
Title
138142-93166 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278655
Title
20240923 Response doc-Sept 2024
Study date
23 September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278656
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278657
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278658
Title
13846-93168 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261819
Title
Cover letter for response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248326
Title
Part 1 Application Overview
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248327
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248328
Title
PAA - Salmonella Vaccines Registration in Australia
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248329
Title
Response to: Pre-Application Assistance APVMA Written Assistance Report, questions from pages 6 to 7
Study date
September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248330
Title
Clonal Structure and Variation in Virulence of Salmonella Enteritidis Isolated from Mice, Chickens, and Humans
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248331
Title
The Transformation of Reference Microbiology Methods and Surveillance for Salmonella With the Use of Whole Genome Sequencing in England and Wales
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248332
Title
What WGS Reveals about Salmonella enterica subsp. Enterica in Wildlife in Germany
Study date
2021
Auth party contact address
-
Data no
248333
Title
Advances in typing and identification of foodborne pathogens
Study date
2021
Auth party contact address
-
Data no
248334
Title
Protection Conferred by a Live Salmonella Enteritidis Vaccine Against Fowl Typhoid in Laying Hens
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248335
Title
Oral Vaccination with a Live Salmonella Enteritidis/Typhimurium Bivalent Vaccine in Layers Induces Cross-protection Against Caecal and Internal Organ Colonization by a Salmonella Infantis Strain
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248336
Title
Salmonella enterica Serotype Typhimurium and its Host-Adapted Variants
Study date
2002
Auth party contact address
-
Data no
248337
Title
Genome Variation and Molecular Epidemiology of Salmonella enterica Serovar Typhimurium Pathovariants
Study date
2018
Auth party contact address
-
Data no
248338
Title
Oral Administration of the Salmonella Typhimurium Vaccine Strain NaI2/Rif9/Rtt to Laying Hens at Day of Hatch Reduces Shedding and Caecal Colonization of Salmonella 4, 12:i:-, the Monophasic Variant of Salmonella Typhimurium
Study date
2015
Auth party contact address
-
Data no
248339
Title
Salmonella Infections: Immune and Non-immune Protection with Vaccines
Study date
2007
Auth party contact address
-
Data no
248340
Title
Vaccination and Early Protection Against Non-host-specific Salmonella Serotypes in Poultry: Exploitation of Innate Immunity and Microbial Activity
Study date
2005
Auth party contact address
-
Data no
248341
Title
Review article: Vaccination and early protection against non-host-specific Salmonella serotypes in poultry: exploitation of innate immunity and microbial activity
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248342
Title
Review: The long view: Salmonella - the last forty years
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248343
Title
Salmonella in Domestic Animals (2nd edition
Study date
2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248344
Title
Salmonella infections: immune and non-immune protection with vaccines
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248345
Title
PAA - APVMA Written assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248346
Title
Pre-application Assistance: APVMA Written Assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248347
Title
Part 6 overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248348
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248349
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248350
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248351
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248352
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248353
Title
Report: Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248354
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248355
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248356
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248357
Title
Report on the fourth semester of monitoring Salmonella Typhimurium isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248358
Title
Study no.: H 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248359
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248360
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248361
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248362
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248363
Title
Study no.:525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248364
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
18 August 1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248365
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248366
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248367
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248368
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248369
Title
Study No.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248370
Title
Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248371
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248372
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248373
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248374
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248375
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254985
Title
2023-06-19 Elanco Salmonella Resp to s159 notice
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248306
Title
Part 7 Overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248307
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248308
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248309
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248310
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248311
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248312
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248313
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248314
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248315
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248316
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248317
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248318
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248319
Title
Study: Gantois et al., 2006
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248320
Title
Study: no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248321
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248322
Title
Study no.: 67/01B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248323
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248324
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138340
Product/Active constituent Name
Application Product Name
MainMan 100 OD Insecticide
Application Date
Application Number
138340
Application Product Name
MainMan 100 OD Insecticide
Application details
Product name:
MainMan 100 OD Insecticide
Product number:
93218
Applicant Name:
ISHIHARA SANGYO KAISHA, LTD
Application purpose and description of use:
Registration of a 100 g/L flonicamid OD oil-based suspension concentrate product for the control of sucking insects in fruit and vegetable crops.
Reference details:
66373 - MAINMAN 500 WG INSECTICIDE
Active constituents:
Active constituent name
65027 - FLONICAMID
Description of data provided:
Data no
249180
Title
Certificate of Analysis
Study date
15/9/2021
Data no
254533
Title
IKI-220 - Vapor Pressure
Study date
30/11/1999
Data no
249191
Title
Validation of analytical HPLC method for the determination of active substance content in an oil dispersion (OD) containing flonicamid.
Study date
9/1/2018
Data no
249192
Title
Development and validation of an Analytical method for the content determination of the impurity Toluene in IKI-220 100 OD
Study date
17/4/2018
Data no
249187
Title
Persistent foaming of IKI-220 100 OD
Study date
29/09/2017
Data no
249190
Title
Certificate of analysis. Determination of the content of active ingredient in IKI-220 100 OD
Study date
29/9/2017
Data no
249181
Title
Information on ingredients
Study date
8/2/2022
Data no
249182
Title
Description of formulation process
Study date
12/02/2022
Data no
249193
Title
Safety Data Sheet IKI-220 100OD
Study date
4/10/2021
Data no
249194
Title
Part 2 Summary
Study date
January 2023
Data no
249183
Title
Accelerated Storage Stability of IKI-220 100 OD in F-HDPE packaging container at 54C for 14 days
Study date
23/3/2020
Data no
249184
Title
Accelerated Storage Stability of IKI-220 100 OD in HDPE/EVOH packaging container at 54C for 14 days
Study date
13/06/2018
Data no
249185
Title
Shelf-Life storage stability of IKI-220 100 OD in HDPE/EVOH Packaging Container over 5 years at 20C (Interim report)
Study date
15/11/2019
Data no
249186
Title
Cold Storage Stability of IKI-220 100 OD in HDPE/EVOH packaging container at 0C for 7 days
Study date
13/06/2018
Data no
249188
Title
Accelerated storage stability for IKI-220 100OD
Study date
09/11/2020
Data no
249189
Title
Accelerated storage stability for IKI-220 100OD
Study date
5/8/2021
Data no
249223
Title
Comparison of flonicamid formulations for control of woolly apple aphid (Eriosoma lanigerum) in apples cv. Jazz - Grove, Tasmania
Study date
5/7/2021
Data no
249224
Title
To compare Flonicamid formulations for control of Woolly Apple Aphid in Apples ??? Pakenham, Vic
Study date
May 2021
Data no
249225
Title
Comparison of MainMan 100 OD with MainMan 500 WG and Movento 240 SC + Hasten for the control of woolly apple aphid (Eriosoma Ianigerum) in apples cv. Red Delicious Stanthorpe, Qld, 2022
Study date
30/07/2022
Data no
249226
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Apples Location: Officer, Victoria Trial Number: 01
Study date
July 2022
Data no
249227
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Apples Location: Officer, Victoria Trial Number: 02
Study date
July 2022
Data no
249228
Title
Comparison of Flonicamid 100 OD with MainMan 500 WG and Movento 240 SC + Hasten for the control of tuber mealybug (Pseudococcus viburni) in apples cv. Royal Gala Stanthorpe, Qld, 2021-22
Study date
14/05/2022
Data no
249229
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Pears Protocol: Pakenham, Victoria
Study date
July 2022
Data no
249230
Title
Evaluation of Flonicamid formulations for control of Longtailed Mealybug in Pears Location: Officer, Victoria
Study date
June 2022
Data no
249231
Title
Evaluation of MainMan 100 OD for control of strawberry aphid (Chaetosiphon fragaefolii) in strawberries cv. Amesti Hillwood, Tasmania 2021-22
Study date
09/02/2022
Data no
249232
Title
Evaluation of MainMan 100 OD for control of Aphids in strawberries
Study date
February 2022
Data no
249233
Title
Comparison of MainMan 100 OD with MainMan 500 WG and Transform 240 SC for the control of strawberry aphids (Chaetosiphon fragaefolii) in strawberries cv. Monterey Stanthorpe, Qld, 2021
Study date
01/12/2021
Data no
249234
Title
To compare MainMan formulations for the control of silverleaf whitefly in tomatoes. Bundaberg / Queensland / 2021
Study date
09/03/2022
Data no
249235
Title
Evaluation of MainMan100 OD for control of silverleaf whitefly in tomatoes Field trial conducted in Bowen, Queensland in 2021
Study date
29/11/2021
Data no
249236
Title
To compare MainMan formulations for the control of silverleaf whitefly in protected cropping tomatoes. Bundaberg / Queensland / 2022
Study date
11/08/2022
Data no
249237
Title
To Compare MainMan formulations for control of Silverleaf Whitefly in cucurbits.
Study date
15/11/2021
Data no
249238
Title
Evaluation of MainMan 100 OD and determination of bioequivalence to MainMan 500 WG for the control of silverleaf whitefly in cucurbits. Field trial conducted in Bowen, Queensland in 2021
Study date
28/11/2021
Data no
249240
Title
To compare MainMan formulations for the control of silverleaf whitefly in cucurbits. Bundaberg / Queensland / 2021
Study date
25/02/2022
Data no
249241
Title
To compare MainMan formulations for the control of silverleaf whitefly in cucurbits. Bundaberg / Queensland / 2021
Study date
10/03/2022
Data no
249242
Title
To compare MainMan formulations for the control of aphids in rockmelons. Bundaberg / Queensland / 2021
Study date
17/02/2022
Data no
249243
Title
Evaluation of MainMan 100 OD and MainMan 500 WG for the control of Melon Aphids in rockmelons. Field trial conducted in Bowen, Queensland in 2021
Study date
02/02/2022
Data no
249244
Title
Evaluation of Flonicamid formulations for control of aphids in pumpkins. Field trial conducted in Bowen, Queensland in 2021
Study date
27/11/2021
Data no
249245
Title
To evaluate MainMan 100 OD for control of aphids in eggplant. Bundaberg / Queensland / 2021
Study date
20/02/2022
Data no
249246
Title
Evaluation of MainMan 100 OD for the control of aphids in eggplants Field trial conducted in Bowen, Queensland in 2021
Study date
10/11/2021
Data no
249247
Title
To evaluate Flonicamid 100 OD for control of green peach aphid (Myzus persicae) in capsicum cv. SV6947 Bundaberg / Queensland / 2022
Study date
05/09/2022
Data no
249248
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. Warlock, Gatton, Queensland, 2019
Study date
08/07/2019
Data no
249249
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. SV6947 Bundaberg, Queensland, 2019
Study date
04/09/2019
Data no
249250
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. Warlock, Bowen, Queensland, 2019
Study date
11/12/2019
Data no
249251
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) and for crop safety in capsicums cv. Remy Virginia, South Australia, 2019
Study date
02/03/2020
Data no
249252
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicums cv. Warlock Bowen, Queensland, 2019
Study date
23/03/2020
Data no
249253
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicums cv. Warlock Gatton, Queensland, 2020
Study date
28/04/2020
Data no
249254
Title
Evaluation of Mainman 500 WG for the control of green peach aphid (Myzus persicae) in capsicum cv. Plato, Gatton, Queensland, 2016
Study date
16/06/2017
Data no
249255
Title
To compare MainMan formulations for control of aphids in potatoes. Bundaberg / Queensland / 2021
Study date
03/02/2022
Data no
249256
Title
Flonicamid formulations for control of aphids in potatoes. Mount Barker (Pot trial) & Dog Lake Road (Crop safety trial), South Australia, 2022
Study date
22/6/2022
Data no
249257
Title
To compare flonicamid formulations for control of aphids in potatoes. Bundaberg / Queensland / 2022
Study date
02/08/2022
Data no
249260
Title
Part 8 Summary
Study date
January 2022
Data no
249239
Title
Evaluation of MainMan 100 OD and determination of bioequivalence to MainMan 500 WG for the control of silverleaf whitefly in rockmelons. Field trial conducted in Bowen, Queensland in 2021
Study date
02/02/2022
Data no
254534
Title
Acute toxicity of IK-220 technical to first-instar larvae of Chironomus riparius
Study date
21/02/2002
Data no
254535
Title
Effects of IKI-220 technical on the development of sediment-dwelling larvae of Chironomus riparius
Study date
23/10/2002
Data no
254536
Title
IKI-220 technical: a 7-day static-renewal toxicity test with duckweed (Lemna gibba G3)
Study date
24/06/2002
Data no
254537
Title
Assessment of side effects of IKI-220 500WG (Teppeki) on the Honeybee (Apis mellifera L.) in a Semi-Field study in The Netherlands after one application on Phacelia tanacetifolia in 2019
Study date
30/07/2020
Data no
254538
Title
Assessment of side effects of IKI-220 500WG (Teppeki) following the OEPP/EPPO Guideline No. 170 on the Honeybee (Apis mellifera L.) in a Semi-Field study in The Netherlands after one application on Phacelia tanacetifolia in 2019
Study date
04/08/2020
Data no
259465
Title
IKI-220: Acute survival of honey bee larvae, Apis mellifera L., during an In Vitro exposure
Study date
13/10/2016
Data no
259466
Title
IKI-220: 22-day survival of honey bee larvae, Apis mellifera L., during an In Vitro exposure
Study date
21/12/2016
Data no
259467
Title
IKI-220: 10-day oral toxicity test with the honey bee (Apis mellifera)
Study date
28/12/2017
Data no
259468
Title
IKI-220 TGAI: Acute contact toxicity test with the honey bee (Apis mellifera)
Study date
19/01/2015
Data no
259469
Title
IKI-220: 13-day oral toxicity test with the adult honey bee (Apis mellifera)
Study date
21/02/2019
Data no
259470
Title
IKI-220 TGAI: Acute oral toxicity test with the honey bee (Apis mellifera)
Study date
09/12/2014
Data no
249219
Title
IKI-220 50%WG: Collembolan Reproduction Test in Soil
Study date
17/9/2020
Data no
249218
Title
IKI-220 50%WG: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil
Study date
29/9/2020
Data no
249213
Title
Side effects of FT1785 500 WG on soil microorganisms: Nitrogen and Carbon cycles
Study date
12/12/2002
Data no
249214
Title
Side effects of Flonicamid Tecnico on soil microorganisms: Nitrogen transformation test
Study date
28/03/2033
Data no
249215
Title
Side effects of Flonicamid Tecnico on soil microorganisms: Carbon transformation test
Study date
07/02/2003
Data no
249216
Title
Effects of IKI-220 50 % WG on the Activity of the Soil Microflora in the Laboratory
Study date
13/12/2002
Data no
249222
Title
Part 7 Summary
Study date
January 2023
Data no
249220
Title
Acute toxicity of F1785 500 WG to earthworm Eisenia fetida
Study date
19/12/2002
Data no
249221
Title
IKI-220 50%WG???Effect on Reproduction in the Earthworm Eisenia fetida
Study date
13/1/2021
Data no
249259
Title
Mainman 500 WG Insecticide label 66373/137302
Study date
12/2022
Auth party contact address
-
Data no
259464
Title
Response to Section 159(1)(a) Notice for application 93218/138340
Study date
September 2023
Data no
249217
Title
Early release of reviewer assessment
Study date
18/08/2014
Data no
249258
Title
Early release of reviewer assessment
Study date
10/10/2013
Data no
249210
Title
Magnitude of the residues of flonicamid in potato (RAC tubers) following two applications of IBE 4084 (IKI-220 100OD) in eight trials (8 RDCS), Northern and Southern Europe (Germany, France, The United Kingdom, The Netherlands, Spain and Italy) ??? 2017
Study date
06/08/2018
Data no
249205
Title
Flonicamid: Magnitude of the residue on tomato (field and greenhouse)
Study date
17/10/2012
Data no
249206
Title
Determination of residues of flonicamid in fruiting vegetables following three applications of Mainman 500 WG
Study date
25/03/2020
Data no
249207
Title
Magnitude of residues of IKI-220 on fruiting vegetables ??? USA in 2001
Study date
14/01/2020
Data no
249208
Title
Flonicamid: magnitude of the residue on strawberry
Study date
14/10/2010
Data no
259458
Title
Magnitude of the residues of flonicamid and its metabolites (TFNA and TFNG) in wheat (RAC Whole plant w/o roots, ears, stem, hay, grain and straw) following one or two foliar applications of IBE 4084 (IKI-220 100 OD) or IBE 3894 (IKI-220 500 WG), Northern and Southern Europe ? 2018.
Study date
11/01/2019
Data no
259459
Title
Magnitude of the residues of flonicamid and its metabolites (TFNA and TFNG) in winter wheat (RAC whole plant, ear, stem, grain, straw) following two foliar applications of IBE 4084 (IKI-220 100OD) and IBE 3894 (IKI-220 50% WG) in four trials (4 DCS), Northern and Southern Europe (Germany, The United Kingdom, Italy and Southern France) ? 2017.
Study date
30/03/2018
Data no
259460
Title
Magnitude of the residues of flonicamid and its metabolites TFNG and TFNA in winter oilseed rape (RAC seeds), following one application of IBE 3894 or IBE 4084 in four trials (4 HS), Northern and Southern Europe (Northern and Southern France and Germany) ? 2017, 2018
Study date
03/12/2018
Data no
259461
Title
Magnitude of the residues of flonicamid and its metabolites (TFNA and TFNG) in winter wheat (RAC forage, hay, grain, straw and processed fractions) following two foliar applications of IBE 4084 (IKI-220 100OD) and IBE 3894 (IKI-220 50% WG) in four trials (4 SDCS), Northern and Southern Europe (France, the Netherlands and Italy) ? 2017.
Study date
07/02/2019
Data no
249209
Title
Storage stability of IKI-220 (F1785) and its major plant metabolites in/on laboratory-fortified matrices from five representative crop groups: oilseed, non-oily grain, leafy vegetable, root and tuber vegetable crop, and fruit or fruiting vegetable, and their processed parts
Study date
4/12/2002
Data no
249211
Title
Residue Database Form for Mainman 100 OD Insecticide
Study date
December 2022
Data no
249212
Title
Part 5 Summary
Study date
January 2023
Data no
259462
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid
Study date
2010
Auth party contact address
-
Data no
259463
Title
Draft registration report Part B Section 7 Metabolism and Residues
Study date
30/11/2019
Data no
249196
Title
Acute Dermal Toxicity (Limit Test) in the Rat with IKI-220 100OD
Study date
31/8/2017
Data no
249200
Title
Acute Eye Irritation/Corrosion in the Rabbit with IKI-220 100OD
Study date
12/1/2018
Data no
249197
Title
IKI-220 100OD: Acute Inhalation Toxicity in Rats
Study date
11/1/2018
Data no
249195
Title
Acute Oral Toxicity (Acute Toxic Class Method) in the Rat with IKI-220 100OD
Study date
18/1/2018
Data no
249198
Title
In vitro Skin Irritation: Human Skin Model Test (Epiderm???) with IKI-220 100OD
Study date
09/1/2018
Data no
249201
Title
Test for Sensitisation (Local Lymph Node Assay ??? LLNA) with IKI-220 100OD
Study date
16/1/2018
Data no
249202
Title
Advice Summary 66373/53527
Study date
14/08/2007
Data no
249203
Title
Toxicology data base form
Study date
July 2021
Data no
249204
Title
Part 3 Summary
Study date
January 2023
Data no
249199
Title
In-vitro human skin penetration of 14C-IKI-220 in IKI-220 OD Test Item
Study date
28/8/2019
Date
Application Date
Application No
Application Number
138164
Product/Active constituent Name
Application Product Name
Fulltec
Application Date
Application Number
138164
Application Product Name
Fulltec
Application details
Product name:
Fulltec
Product number:
93179
Applicant Name:
SPRAYTEC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 216.1g/L Phosphoric Acid Soluble Liquid product to ameliorate water hardness and pH, improve spray coverage and target penetration, and minimise inadvertent losses due to evaporation, drift and foaming.
Reference details:
62541 - WETTER 1000 SURFACTANT
47999 - HASTEN SPRAY ADJUVANT
41255 - UPTAKE SPRAYING OIL
46871 - Nufarm BS1000 Adjuvant
41510 - Nufarm Liase Adjuvant
54116 - AGRAL SPRAY ADJUVANT
Description of data provided:
Data no
248490
Title
Quantification Study 5 Batch
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248482
Title
Part 2 A Chemistry and Manufacture
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248483
Title
Part 2 B Chemistry and Manufacture
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276598
Title
Investigation into the Efficacy of Spraytec's Fulltec and Fulltec Max Chelating Agent and their pH Reducing Properties.
Study date
June, 2024
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248485
Title
Product Technical Sheet
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248486
Title
Product Technical Sheet
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248487
Title
Quality Report
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248488
Title
Quality Report
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248489
Title
Study of Physico-Chemical Properties
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248484
Title
Physico - Chemical Properties
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276595
Title
Efficacy of Spraytec Adjuvants, Applied Post-Emergent with Various Herbicides, for Amsinckia (Amsinckia sp. and Deadnettle (Lamium amplexicaule) control in Wheat cv. Scepter.
Study date
Dec, 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276596
Title
Agricultural Trials with an Agronomic Focus, Spraytec Canola Herbicide Trial Winter 2023
Study date
September, 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276597
Title
Spraytec Additives: Post-Emergent ARG Contral in Canola, Gairdner WA.
Study date
July, 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
276599
Title
Response to APVMA S159 Notice
Study date
01/06/2024
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248518
Title
Knockdown Trial Greenmount, QLD, 2021
Study date
September, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248519
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248520
Title
Spraytec Adjuvant/Knockdown
Study date
May, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248521
Title
Spraytec Adjuvants and Trace Elements
Study date
May, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248491
Title
Part 8 - Efficacy and Crop Safety
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248492
Title
Can the adjuvant FullTec or FullTec Max boost efficacy of glyphosate, 2,4-D and Triclopyr to control summer weeds in Australia
Study date
March, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248493
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted annual ryegrass (Lolium rigidum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248494
Title
Evaluation of Fulltec and Fulltec Max when combined with Nitro 240 SL for the control of potted annual ryegrass (Lolium rigidum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248495
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted wild radish (Raphanus raphanistrum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248496
Title
Evaluation of Fulltec and Fulltec Max when combined with Velocity 247 EC for the control of potted wild radish (Raphanus raphanistrum) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248497
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248498
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
Nov, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248499
Title
Evaluation of Fulltec and Fulltec Max when combined with Wipe-out 450 SL for the control of potted clover (Trifolium sp.) Kewdale, Western Australia, 2020
Study date
May, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248500
Title
Efficacy of Top Zinc Max applied as a seed treatment or a foliar application mixed with Velocity applied to Yitpi wheat at BBCH21 or mixed with a fungicide and applied at BBCH30 Northam, WA, 2020
Study date
April, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248501
Title
Summer Weed Control Griffith, NSW, 2020
Study date
April, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248502
Title
Summer Weed Control Maaoupe, SA, 2021
Study date
April, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248503
Title
A comparison of Fulltec and Fulltec Max on efficacy of herbicide mixes on paddy melon (Cucuis myriocarpus) Northam, WA, 2020
Study date
May, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248504
Title
Spraytec Knockdown Trial Narrabri, NSW, 2021
Study date
July, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248505
Title
Yield response to herbicide and fungicide treatments using different adjuvants in barley, Quairading, Western Australia 2020
Study date
Mar, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248506
Title
The Efficacy of Spraytec Adjuvants on a Summer Spray, Cascade 2020/2021
Study date
Feb, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248507
Title
The efficacy of FullTec and FullTec Max Adjuvants in a Summer Knock-Down MYRUP 2021
Study date
March, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248508
Title
ntrol of summer weeds (Afghan melon) using Fulltec and Fulltec Max additives to herbicide mixtures, Meckering, Western Australia 2020
Study date
September, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248509
Title
Adjuvant mixtures for the control of prickly paddy melon (Cucumis myriocarpus) and caltrop (Tribulus terrestris orientalis) in a summer fallow, York, Western Australia 2020
Study date
March, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248510
Title
Efficacy of Fulltec and Fulltec Max for summer weed control in fallow Nelshaby, South Australia, 2020
Study date
June, 2020
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248511
Title
djuvant Packages on Herbicide and Fungicide Applications in Wheat Coomalbidgup, Western Australia 2021
Study date
Dec, 2021
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248512
Title
Alternative adjuvants/mix partners used in combination with herbicides and fungicides in wheat, York, Western Australia 2021
Study date
Feb, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248513
Title
Alternative adjuvants/mix partners used in combination with herbicides and fungicides in canola, York, Western Australia 2021
Study date
Feb, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248522
Title
Wind Tunnel Trial
Study date
Feb, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248514
Title
Evaluation of Fulltec in combination with Rival 750 WG for crop safety to potted barley cv. Baudin. Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248515
Title
Evaluation of Fulltec in combination with Rival 750 WG for crop safety to potted wheat cv. Zen. Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248516
Title
Evaluation of Fulltec in combination with Prosaro 420 SC for crop safety to potted wheat cv. Zen Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248517
Title
Evaluation of Fulltec in combination with Prosaro 420 SC for crop safety to potted barley cv. Baudin Kewdale, Western Australia, 2021
Study date
March, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
264504
Title
Response to s159 Notice
Study date
Nov 2023
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248481
Title
Covering Letter
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Date
Application Date
Application No
Application Number
138168
Product/Active constituent Name
Application Product Name
Fulltec Max
Application Date
Application Number
138168
Application Product Name
Fulltec Max
Application details
Product name:
Fulltec Max
Product number:
93181
Applicant Name:
SPRAYTEC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 123.3g/L phosphoric acid soluble liquid product to ameliorate water hardness and pH, improve spray coverage and target penetration, and minimise inadvertent losses due to evaporation, drift and foaming.
Reference details:
62541 - WETTER 1000 SURFACTANT
47999 - HASTEN SPRAY ADJUVANT
41255 - UPTAKE SPRAYING OIL
46871 - Nufarm BS1000 Adjuvant
41510 - Nufarm Liase Adjuvant
54116 - AGRAL SPRAY ADJUVANT
Description of data provided:
Data no
248526
Title
Fulltec Max 00610-QNT
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248523
Title
Part 2 - Chemistry and Manufacturing
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248524
Title
Study of Physico-Chemical Properties
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Data no
248525
Title
Fulltec Max 00610-EQ
Study date
Dec, 2022
Auth party contact address
U1/8 Emplacement Cres Hamilton Hill Australia
Date
Application Date
Application No
Application Number
138092
Product/Active constituent Name
Application Product Name
Uvasys Vivo Sulphur Dioxide Generator
Application Date
Application Number
138092
Application Product Name
Uvasys Vivo Sulphur Dioxide Generator
Application details
Product name:
Uvasys Vivo Sulphur Dioxide Generator
Product number:
93143
Applicant Name:
Tessara Pty Ltd
Application purpose and description of use:
Registration of a 150 g/kg meta bisulphate slow release sulphur dioxide generator product for table grape preservation during cold storage.
Reference details:
52162 - UVASYS SULPHUR DIOXIDE GENERATORS
Description of data provided:
Data no
247594
Title
Certificate of Analysis sodium metabisulphite.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268473
Title
Iodine titration and NaOH emission testing method validation. Doc No. T05.06.0323
Study date
September 2023
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247592
Title
Product information sheets for adhesive components.
Study date
2008
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247593
Title
Product data sheets for polypropylene constituents. Various dates and suppliers
Study date
2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247596
Title
Uvasys Vivo Sulphur Dioxide Generator Chemistry Dossier ID DC10-45410985.
Study date
December 2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268472
Title
Uvasys Vivo Sulphur Dioxide Generator Chemistry Dossier ID DC10-45410985. December 2022, Amended 3 Feb and 11 March 2024
Study date
11 March 2024
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
267528
Title
Accelerated Storage Stability Report. Amended Report date 2 February 2024.
Study date
2 Feb 2024
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247595
Title
Accelerated Storage Stability Report
Study date
2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268474
Title
.Accelerated Storage Stability Report. Amended Report date 2 February 2024
Study date
2 February 2024
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
268475
Title
Physico-chemical Properties for UVASYS sheets over 3 years stored between 15-30?C.
Study date
August 2018.
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247598
Title
Uvasys Vivo Trial Report 2020. Tessara Research and Development.
Study date
July 2020
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247599
Title
Uvasys Vivo Second In-house Verification Trial Report???
Study date
March 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247600
Title
Uvasys Vivo Independent Verification Trial Report
Study date
July 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247601
Title
Uvasys Vivo in table grapes: Storage trial.
Study date
June 2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247602
Title
Frigga data report for Grower trial A Colignan Victoria.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247603
Title
Sulphur Dioxide Residues in Grapes for Grower trial A Colignan
Study date
2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247604
Title
Frigga data report for Grower trial B Mundubbera Queensland
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256919
Title
Uvasys Vivo 93143_138092 Response to June 27 2023 s159 Notice
Study date
27 July 2023
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256920
Title
Uvasys Efficacy dossier DC10-454109 - edited to include s159 response information
Study date
July 2023
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256921
Title
Australian Trial 2 Grower Trial A Colignan
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256922
Title
Australian Trial 3 Grower Trial B Mundubbera 2020
Study date
2020
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256923
Title
Grower Trial A Colignan Victoria. Raw data for Sweet Sapphire grapes.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256924
Title
Grower Trial A Colignan Victoria.Raw data for Sweet Sapphire grapes.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256925
Title
Grower Trial A Colignan Victoria. Raw data for Timco grapes.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256926
Title
Raw data Spreadsheet ?- Grower Trial B Mundubbera Queensland.
Study date
2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256927
Title
Uvasys Vivo Second In-house Verification March 2021 taste and stem quality raw data spreadsheet.
Study date
March 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
256928
Title
Uvasys Vivo Second In-house Verification July 2021 taste and stem quality raw data spreadsheet.
Study date
July 2021
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247605
Title
Uvasys Vivo Crop Safety and Efficacy dossier DC10-45410985
Study date
16 Dec 2022
Auth party contact address
Unit 2 129 Industrial Park 35 Kinghall Ave, Epping 2 South Africa
Data no
247597
Title
Uvasys Sulphur Dioxide Generators label (APVMA No. 52162_117777.
Study date
1 Oct 2010
Auth party contact address
-