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

148531
Product/Active constituent Name

Application Product Name

Albaugh Icasso 240 Herbicide

Application details

Product name:

Albaugh Icasso 240 Herbicide

Product number:

80906

Applicant Name:

ALBAUGH AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to vary registered particulars.

Reference details:

51144 - ARYSTA SELECT HERBICIDE
51144 - SELECT 240 HERBICIDE
62806 - TITAN CLETHODIM 240 HERBICIDE
65300 - Cleverdim 240 Herbicide
65300 - RAINBOW CLETHODIM 240 HERBICIDE
81059 - KELPIE CLETH-D 240 EC HERBICIDE
85396 - Platinum 240 Herbicide
85428 - Genfarm Clethodim 240 Herbicide

Active constituents:

Active constituent name
59208 - CLETHODIM

Description of data provided:

Data no
286898
Author
Somervaille A
Title
Appendix 8.2 Bioequivalence trial_Awnless Banyard_Cotton_Albaugh Clethodim 240_Dec24
Study date
01/02/2025
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286896
Author
Albaugh Australia Pty
Title
2 0 Chemistry dossier_Icasso 240 Herbicide
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286890
Author
Albaugh Australia Pty
Title
Appendix 2.2 COA for Clethodim TG 94%
Study date
10/06/2023
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286899
Author
Albaugh Australia Pty
Title
8.0 Efficacy Dossier_Albaugh Icasso 240 Herbicide
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286893
Author
Srinivas K
Title
Appendix 2.5 Study No. 2802. Study on the physico-chemical properties of Clethodim 240
Study date
24/07/2020
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286900
Author
Albaugh Australia Pty
Title
Executive Summary
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286894
Author
Srinivas K
Title
Appendix 2.6 Study on the accelerated storage and packaging stability of clethodim
Study date
06/08/2020
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286897
Author
Somervaille A
Title
Appendix 8.1 Bioequivalence trial_Wild Oats_Chickpea_Albaugh Clethodim 240_Aug24
Study date
10/10/2024
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286891
Author
As above
Title
Appendix 2.3 Manufacturing process Clethodim 240gL EC
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286892
Author
Srinivas K
Title
Appendix 2.4 Study No. 2801. Study on the physico-chemical properties of Clethodim 240
Study date
06/08/2020
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286895
Author
Srinivas K
Title
Appendix 2.7 Report 2799. Method validation of Clethodim 240gL EC
Study date
10/07/2020
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
286889
Author
Anonymous
Title
Appendix 2.1 SDSs for non-active_Albaugh Icasso 240 Herbicide
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Date

Application Date

Application No

Application Number

148195
Product/Active constituent Name

Application Product Name

Chikara 250 WG Herbicide

Application details

Product name:

Chikara 250 WG Herbicide

Product number:

96109

Applicant Name:

ISHIHARA SANGYO KAISHA, LTD

Application purpose and description of use:

Registration of a 250 g/kg Flazasulfuron water dispersible granule (WG) product for the control of various weeds in Turf.

Reference details:

90560 - Katana 250 WG Herbicide

Active constituents:

Active constituent name
65347 - FLAZASULFURON

Description of data provided:

Data no
286403
Author
Ishihara Sangyo Kaisha, Ltd.
Title
Reference Label
Study date
30 March 2025
Authorising party
Applicant
Data no
286409
Author
Sumner M., Hourigan C.
Title
SG-3505 Comparison of UPH-160 250 WG with Monument 100 OD for control of subterranean clover (Trifolium subterraneum), capeweed (Arctotheca calendula), flatweed (Hypochaeris radicata) and silver grass (Vulpia spp.) in low maintenance couch grass (Cynodon dactylon)
Study date
17 November, 2011
Authorising party
Applicant
Data no
286417
Author
Scopelianos, A.
Title
SG-3527 Evaluation of IKH-160 250 WG for overseeding Santa Ana couch with perennial ryegrass var. Pennant III Five Ways, Victoria, 2012
Study date
3 April, 2013
Authorising party
Applicant
Data no
286400
Author
Ishihara Sangyo Kaisha, Ltd.
Title
Part 8 Efficacy and Crop Safety Chikara 250 WG Herbicide
Study date
11 April 2025
Authorising party
Applicant
Data no
286423
Author
Australian Environment Agency Pty Ltd
Title
ISK Flazasulfuron 250 WG Herbicide Application to Turf
Study date
31 October 2023
Authorising party
Applicant
Data no
286406
Author
APVMA
Title
Final Technical Report ISK Flazasulfuron 250 WG Herbicide
Study date
18 January 2013
Authorising party
Applicant
Data no
286420
Author
Grove, M.
Title
SG 3524 To evaluate SL-160 at 4 timings prior to overseeding bermudagrass with perennial ryegrass
Study date
5 June, 2006
Authorising party
Applicant
Data no
286397
Author
APVMA
Title
Environmental Technical Report
Study date
22 December 2016
Authorising party
Applicant
Data no
286426
Author
Australian Environment Agency Pty Ltd
Title
ISK Flazasulfuron 250 WG Herbicide Targeted Environmental Risk Assessment,
Study date
5 May 2015
Authorising party
Applicant
Data no
286401
Author
Ishihara Sangyo Kaisha, Ltd.
Title
Proposed RLP
Study date
30 March 2025
Authorising party
Applicant
Data no
286415
Author
Loch D.S., Pearce, W.R.
Title
SG-3511 Screening Warm-Season Turfgrass Species For Tolerance of Group A Herbicides
Study date
8 November, 2012
Authorising party
Applicant
Data no
286421
Author
Grove, M.
Title
SG3525 Evaluate three rates of SL-160 at 4 timings prior to overseeding for safety to the overseeded turf and for fall and spring control bluegrass
Study date
7 June 2006
Authorising party
Applicant
Data no
286398
Author
APVMA
Title
Qualification fo the Environmental Technical Reports
Study date
21 April 2017
Authorising party
Applicant
Data no
286392
Author
Ishihara Sangyo Kaisha, Ltd
Title
Part 2 Chemistry and Manufacturing
Study date
31 March 2025
Authorising party
Applicant
Data no
286404
Author
Ishihara Sangyo Kaisha, Ltd.
Title
US label Katana Turf
Study date
30 March 2025
Authorising party
Applicant
Data no
286412
Author
Looby, P., Harvey, S.
Title
SG-3508 Evaluation of UPH-160 250WG selectivity and efficacy in several warm season turf varieties
Study date
17 April, 2011
Authorising party
Applicant
Data no
286395
Author
APVMA
Title
Correspondence from APVMA 8s Notice
Study date
21 May 2018
Authorising party
Applicant
Data no
286418
Author
Takashi, T., Ohno, K., Sakashita, N.
Title
SG-3527 Herbicidal Activity of SL-160
Study date
November, 1996
Authorising party
Applicant
Data no
286424
Author
APVMA
Title
APVMA Environmental Technical Report
Study date
22 December 2016
Authorising party
Applicant
Data no
286407
Author
Ishihara Sangyo Kaisha, Ltd.
Title
Response to letter of 18 January 2013
Study date
18 January 2013
Authorising party
Applicant
Data no
286413
Author
Cookson L.
Title
SG-3509 Evaluation of UPH-160 250 WG for the control of weeds in warm season turf species Cynodon dactylon
Study date
1 June, 2012
Authorising party
Applicant
Data no
286396
Author
APVMA
Title
Office of Chemical Safety Health Risk Assessment Technical Report
Study date
9 April 2013
Authorising party
Applicant
Data no
286419
Author
Powell, A. J.
Title
SG3512 Comparison of several sulfonylurea herbicides for control of or safety to several grasses and weeds
Study date
19 December, 2003
Authorising party
Applicant
Data no
286427
Author
Ishihara Sangyo Kaisha, Ltd
Title
Correspondence Response to Environmental (Draft) Report
Study date
12 May 2015
Authorising party
Applicant
Data no
286416
Author
Looby, P., Harvey, S.
Title
SG3526 Evaluation of Evaluation of UPH-160 WG selectivity and efficacy in several warm season turf varieties
Study date
8 November, 2012
Authorising party
Applicant
Data no
286410
Author
Sumner, M., Hourigan, C.
Title
SG-3506 Comparison of UPH-160 250 WG with Monument 100 OD for control of winter grass (Poa annua) in couch grass (Cynodon dactylon) and Kikuyu (Pennisetum clandestinum) turf,
Study date
24 November, 2011
Authorising party
Applicant
Data no
286393
Author
de Ryckel, Ing., B.
Title
Physical and Chemical Properties and Storage Stablility tests of SL-160 25 WG (ASCE 3814)
Study date
21 March 2001
Authorising party
Applicant
Data no
286399
Author
APVMA
Title
Early release of Review assessment Efficacy FTR
Study date
18 January 2013
Authorising party
Applicant
Data no
286405
Author
Ishihara Sangyo Kaisha, Ltd.
Title
Previously submitted Part 8
Study date
April 2013
Authorising party
Applicant
Data no
286411
Author
Howat, P.
Title
SG-3507 To evaluate UPH-160 for the control of a range of weeds in turf. Compare UPH-160 to the standard product Monument Selective Herbicide
Study date
15 June, 2011
Authorising party
Applicant
Data no
286394
Author
Minami, R., Hayashi, K.
Title
Analytical Method of an active Ingredient in SL-160 (25WG)
Study date
14 September 1995
Authorising party
Applicant
Data no
286425
Author
APVMA
Title
Qualification of the Environmental Technical Reports
Study date
21 April 2017
Authorising party
Applicant
Data no
286408
Author
Loch DS.
Title
Comments on Zoysia tolerance
Study date
2013
Authorising party
Applicant
Data no
286402
Author
Ishihara Sangyo Kaisha, Ltd.
Title
ISK Flazasulfuron 250 WG Herbicide label
Study date
17 April 2025
Authorising party
Applicant
Data no
286414
Author
Scopelianos, A.
Title
SG-3510 Evaluation of UPH-160 250 WG for weed control in Santa Ana couch
Study date
17 April, 2011
Authorising party
Applicant
Data no
286422
Author
Ishihara Sangyo Kaisha, Ltd
Title
Part 7 Chikara
Study date
31 March 2025
Authorising party
Applicant
Data no
286428
Author
Ishihara Sangyo Kaisha, Ltd
Title
Proposed RLP for Chikara 250 WG Herbicide
Study date
31 March 2025
Authorising party
Applicant
Date

Application Date

Application No

Application Number

148440
Product/Active constituent Name

Application Product Name

VIDRE+

Application details

Product name:

VIDRE+

Product number:

96178

Applicant Name:

FRESH INSET S.A.

Application purpose and description of use:

Approval of a new manufacturing source of 1-Methylcyclopropene, and registration of a 1-Methylcyclopropene Vapour releasing product for use for post-harvest treatment of certain fruits for improved quality during shipping, storage or handling as specified in the Directions for Use.

Reference details:

59713 - SMARTFRESH SMARTTABS
89703 - SmartFresh InBox Post-Harvest Growth Regulator
83316 - Floratech PROLONG Growth Regulator

Active constituents:

Active constituent name
96240 - 1-Methylcyclopropene

Description of data provided:

Data no
286618
Author
M. SAKALDA????
Title
8.28 VIDRE+ TOMATO RESULT REPORT (LAPSEK????)
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286572
Author
A. Hui
Title
2.8 Method Validation
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286595
Author
E. Hutcheon
Title
8.6 TRIAL REPORT Vidre Plus - Grapes - Storage
Study date
January 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286612
Author
C. H. Crisosto
Title
8.22 2024-QUALITY OF LETTUCE (Lactuca sativa) AFTER COLD STORAGE USING VIDRE+ TECHNOLOGY.
Study date
2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286609
Author
A. Cavicchi
Title
8.20 To evaluate the efficacy of VIDRE+ on blueberry in post-harvest (Italy)
Study date
January 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286586
Author
Multiple, EFSA
Title
6.2 Peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene
Study date
May 2018
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286592
Author
T. Gorbing
Title
8.3 Efficacy trials on Apple with the post-harvest product Vidre+, 2022
Study date
July 2017
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286598
Author
M. Sakaldas
Title
8.9 VIDRE+ GRAPE RESULT REPORT
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286575
Author
Multiple, EFSA
Title
3.3 Peer review of the perticide risk assessment of the active substancr 1-methylcyclopropene
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286569
Author
Anon
Title
2.5 SDS for non-active ingredients
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286615
Author
G. Donzella
Title
8.25 To evaluate the efficacy of VIDRE+ on tomato in post-harvest (Italy)
Study date
February 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286606
Author
C. H. Crisosto
Title
8.17 QUALITY OF RED RASPBERRY (RUBUS IDAEUS L.) AFTER COLD STORAGE USING FRESH INSERT?? TECHNOLOGY
Study date
2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286563
Author
J. Priddle
Title
1.1. Executive Summary
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286589
Author
J. Priddle
Title
8.0 Efficacy Dossier
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286583
Author
T. Malefyt
Title
5.1 Vidre+ Residue Waiver Document
Study date
August 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286593
Author
A. Leitner
Title
8.4 Efficacy trials on Apple with the post-harvest product Vidre+, 2022
Study date
December 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286570
Author
Anon
Title
2.6 SDSs for non-active ingredients
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286601
Author
J. McCarthy
Title
8.12 Evaluation of 1-MCP for post harvest storage of Lychee
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286607
Author
C. Lazzarin
Title
8.18 To evaluate the efficacy of VIDRE+ on raspberry in post-harvest (Italy)
Study date
November 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286564
Author
J. Priddle
Title
2.0 Chemistry dossier
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286578
Author
S. Matricardi
Title
3.5 1-MCP 3.3% VP: Acute Inhalation Toxicity in Rats
Study date
December 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286590
Author
A. Wolan
Title
8.1 1-MCP releasing profile Analysis of label containing 1-methylcyclopropene - gas releasing curve
Study date
November 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286584
Author
J. Priddle
Title
6.0 OHS Dossier
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286604
Author
J. V. S??NCHEZ
Title
8.15 EVALUATION OF THE EFFICACY OF THE PHYSIOLOGICAL REGULATOR VIDRE+ TO REDUCE ETHYLENE EMISSION IN POST-HARVEST FRUIT CROPS. BERRY FRUITS GROUP - UCHUVA (Physalis peruviana L) AND STONE FRUITS - AVOCADO (Persea americana Mill). Cv. Hass.
Study date
March 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286613
Author
J. Rosen
Title
8.23 Postharvest Study to Evaluate the Efficacy of Vidre+ In Maintaining Postharvest Quality of Arugula
Study date
July, 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286610
Author
C. Lazzarin
Title
8.20b To evaluate the efficacy of VIDRE+ on blueberry in post-harvest (Italy)
Study date
November 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286587
Author
Multiple, EFSA
Title
6.3 Peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene (updated)
Study date
July, 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286581
Author
S. Matricardi
Title
1-MCP 3.3% VP: Primary Eye Irritation in Rabbits
Study date
January 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286599
Author
M. Sakaldas
Title
8.10 VIDRE+ GRAPE RESULT REPORT
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286576
Author
S. Matricardi
Title
3.3 1-MCP 3.3% VP Acute Oral Toxicicty - Up-And-Down Procedure in Rats
Study date
December 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286616
Author
A. P. Jacomino
Title
8.26 Effect of the application of VIDRE+ growth regulator on the preservation of tomato postharvest quality
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286605
Author
C. N. D??AZ
Title
8.16 EVALUATION STUDY OF BIOLOGICAL EFFECTIVENESS OF VIDRE+ (1-MCP) AS A GROWTH REGULATOR FOR POST-HARVEST FRESHNESS PROTECTION IN RASPBERRY FRUITS
Study date
NOVEMBER 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286588
Author
Anon
Title
6.4 SDS for Vidre+
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286582
Author
J. Durando
Title
3.9 Vidre+ Stickers 233 mg/m2: Primary Skin Irritration in Rabbits
Study date
December 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286573
Author
J. Priddle
Title
3.0 Toxicology Dossier
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286596
Author
M. Sakaldas
Title
8.7 VIDRE+ GRAPE RESULT REPORT (2)
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286602
Author
A. Malar??n
Title
8.13 BIOLOGICAL EFFICACY TEST REPORT DETERMINATION OF 1-MCP VIDRE+ DOSAGE IN PALTO (Persea americana)
Study date
July 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286608
Author
A. Cavicchi
Title
8.19 To evaluate the efficacy of VIDRE+ on raspberry in post-harvest (Italy).
Study date
January 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286585
Author
A. Wolan
Title
6.1 1-MCP releasing profile Analysis of label containing 1-methylcyclopropene - gas releasing curve
Study date
November 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286579
Author
J. Durando
Title
3.6 VIDRE+ STICKERS 33 mg/m2: Dermal Sensitization Test in Guinea Pigs - Bueheler Method
Study date
September 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286574
Author
Anon
Title
3.1 SDSs for non-active ingredients
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286597
Author
M. Sakaldas
Title
8.8 VIDRE+ GRAPE RESULT REPORT (2)
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286603
Author
B. G. Defilippi Bruzzone
Title
8.14 2023 RESULTS REPORT Evaluation of the effects of Vidre+ stickers on the evolution of condition attributes during post-harvest in cv. Hass avocados
Study date
March 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286614
Author
C. Lazzarin
Title
8.24 To evaluate the efficacy of VIDRE+ on tomato in post-harvest (Italy)
Study date
November 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286611
Author
C. H. Crisosto
Title
8.21 2024-BABY SPINACH (Spinacia oleracea L.) QUALITY AFTER USING VIDRE+ TECHNOLOGY DURING COLD STORAGE
Study date
2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286580
Author
S. Matricardi
Title
3.7 1-MCP 3.3 VP: Local Lymph Node Assay (LLNA) in Mice
Study date
December 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286600
Author
J. Cristobal Arroyo
Title
8.11 EFFICACY OF VIDRE + (1-MCP) IN POST-HARVEST ON BROWNING INDEX IN RED GLOBE TABLE GRAPES
Study date
June 2024
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286571
Author
Anon
Title
2.7 Vidre+ Stickers 33 mgm3 Accelerated Storage Stability and Corrosion
Study date
April 2025
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286617
Author
M. SAKALDA????
Title
8.27 VIDRE+ TOMATO RESULT REPORT (?????ANAKKALE)
Study date
September 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286594
Author
M. Sakaldas
Title
8.5 VIDRE+ APPLE RESULT REPORT (??ANAKKALE)
Study date
December 2023
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286591
Author
Anon
Title
8.2 Effects of Vidre+ (1-MCP) over postharvest apple maturation process
Study date
August 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286577
Author
S. Matricardi
Title
3.4 1-MCP 3.3% VP: Acute Dermal Toxicity in Rats
Study date
December 2022
Authorising party
Applicant
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Date

Application Date

Application No

Application Number

148533
Product/Active constituent Name

Application Product Name

Decco Propi 220 EC Fungicide

Application details

Product name:

Decco Propi 220 EC Fungicide

Product number:

96210

Applicant Name:

DECCO US POST-HARVEST INC.

Application purpose and description of use:

Registration of a 220 g/L propiconazole EC product for control of certain post-harvest diseases in citrus.

Reference details:

86217 - CHAIRMAN Fungicide

Active constituents:

Active constituent name
69316 - PROPICONAZOLE

Description of data provided:

Data no
286910
Author
Cheng Xu
Title
Certificate of Analysis
Study date
01/09/2024
Authorising party
Applicant
Data no
286921
Author
Syngenta Crop Protection
Title
Mentor US label
Study date
2014
Authorising party
Public
Auth party contact address
-
Data no
290196
Author
V A Murphy
Title
Decco Propi EC Acute Dermal Toxicity in rats
Study date
04/09/2019
Authorising party
Applicant
Data no
302338
Author
F Johnston
Title
Part 8 Summary Version 2
Study date
March 2026
Authorising party
Applicant
Data no
308049
Author
M Liberale
Title
Purity of CDX 208A FP (Propiconazole 25% EC) and analytical method validation for active ingredient content Propiconazole
Study date
07/05/2018
Authorising party
Applicant
Data no
286918
Author
A H McKay, H Forster, J E Adaskaveg
Title
Efficacy and application strategies for propiconazole as a new postharvest fungicide for managing sour rot and green mold of citrus fruit
Study date
February 2012
Authorising party
Public
Auth party contact address
-
Data no
290199
Author
V A Murphy
Title
Decco Propi EC Acute Dermal Irritation in rabbits
Study date
26/08/2019
Authorising party
Applicant
Data no
286919
Author
S B Joyner
Title
Notice of pesticide registration EPA Reg. Number 2792-90
Study date
23/11/2021
Authorising party
Applicant
Data no
302336
Author
M Sales
Title
Decco Propi 220 EC Fungicide Permit PER96286 usage report
Study date
February 2026
Authorising party
Applicant
Data no
286913
Author
K Calderon-Kawasaki
Title
Decco PROPI EC product analysis
Study date
31/10/2024
Authorising party
Applicant
Data no
286916
Author
B Ribeiro and M T Nouri
Title
Final report: Efficacy of Decco Propi EC for post-harvest disease control in citrus: laboratory trial
Study date
22/07/2024
Authorising party
Applicant
Data no
286922
Author
F Johnston
Title
Part 8 Summary
Study date
January 2025
Authorising party
Applicant
Data no
302337
Author
APVMA
Title
Permit to allow supply and emergency use of an unregistered agvet Chemical Product for post harvest control of blue mould, green mould and Sour rot in citrus Permit number PER96286
Study date
29/07/2025
Authorising party
Public
Auth party contact address
-
Data no
290197
Author
A Doig
Title
Decco Propi EC Acute Inhalation Toxicity in rats
Study date
24/09/2019
Authorising party
Applicant
Data no
308050
Author
F Johnston
Title
Part 2 Summary revised
Study date
July 2026
Authorising party
Applicant
Data no
286917
Author
M Sales
Title
Propiconazole Lab Trial
Study date
25/04/2024
Authorising party
Applicant
Data no
302334
Author
M T Nouri and M Sales
Title
Second year laboratory trial: efficacy of Decco Propi EC for post-harvest disease control in citrus
Study date
15/03/2025
Authorising party
Applicant
Data no
286911
Author
C Figueroa
Title
Information on ingredients
Study date
18/08/2020
Authorising party
Applicant
Data no
290194
Author
B A Akinlosotu
Title
Acute Toxicity Review for EPA Reg. No / File Symbol: 2792-ON
Study date
23/7/2021
Authorising party
Applicant
Data no
290200
Author
V A Murphy
Title
Decco Propi EC Skin Sensitization in guinea pigs
Study date
09/09/2019
Authorising party
Applicant
Data no
286920
Author
Syngenta Australia Pty Ltd
Title
Chairman Fungicide 86217/115030
Study date
30/7/2018
Authorising party
Public
Auth party contact address
-
Data no
286914
Author
Decco US Post Harvest Inc
Title
Safety Data Sheet
Study date
29/11/2021
Authorising party
Applicant
Data no
286912
Author
C Figueroa
Title
Description of formulation process
Study date
18/08/2020
Authorising party
Applicant
Data no
290195
Author
V A Murphy
Title
Decco Propi EC Acute Oral Toxicity (UDP) in rats
Study date
02/10/2019
Authorising party
Applicant
Data no
286915
Author
F Johnston
Title
Part 2 Summary
Study date
January 2025
Authorising party
Applicant
Data no
290198
Author
V A Murphy
Title
Decco Propi EC Acute Eye Irritation in rabbits
Study date
26/08/2019
Authorising party
Applicant
Data no
302335
Author
C Melchor
Title
Final report: Efficacy of Decco Propi EC for post-harvest disease control in citrus: laboratory trial
Study date
01/04/2025
Authorising party
Applicant
Date

Application Date

Application No

Application Number

148156
Product/Active constituent Name

Application Product Name

Transplan Fungicide

Application details

Product name:

Transplan Fungicide

Product number:

96095

Applicant Name:

ANHUI HUAXING CHEMICAL INDUSTRY CO LTD

Application purpose and description of use:

Registration of a 250 g/L Trifloxystrobin +250 g/L Fluopyram suspension concentrate for control of diseases in stone fruit.

Reference details:

65560 - LUNA SENSATION FUNGICIDE

Active constituents:

Active constituent name
91621 - Trifloxystrobin
Active constituent name
93984 - FLUOPYRAM

Description of data provided:

Data no
311238
Author
Anon
Title
Determination of pourability for Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
September 2026
Authorising party
Applicant
Data no
285802
Author
Anon
Title
SAFETY DATA SHEET
Study date
January 2025
Authorising party
Applicant
Data no
309798
Author
M L da Silva
Title
Analytical methodology validation and degree of purity study of Fuopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
July 2025
Authorising party
Applicant
Data no
285796
Author
Anon
Title
Safety data sheet
Study date
June 2024
Authorising party
Applicant
Data no
309801
Author
Anon
Title
Determination of pourability for Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
August 2026
Authorising party
Applicant
Data no
285805
Author
GF Smart
Title
Registration of Transplan Fungicide: Executive Summary
Study date
April 2025
Authorising party
Applicant
Data no
285793
Author
H Lu
Title
Specification of Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
February 2025
Authorising party
Applicant
Data no
285799
Author
Anon
Title
SAFETY DATA SHEET
Study date
June 2024
Authorising party
Applicant
Data no
292340
Author
GF Smart
Title
RESPONSE to s159: Transplan Fungicide (96095/148156)
Study date
September 2025
Authorising party
Applicant
Data no
285791
Author
U Gadade
Title
Determination of Accelerated Storage Stability of Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
January 2025
Authorising party
Applicant
Data no
292343
Author
GF Smart
Title
Overview of efficacy data:Transplan Fungicide
Study date
September 2025
Authorising party
Applicant
Data no
285794
Author
Anon
Title
Certificate of analysis
Study date
March 2025
Authorising party
Applicant
Data no
285800
Author
Anon
Title
SAFETY DATA SHEET
Study date
June 2024
Authorising party
Applicant
Data no
285797
Author
Anon
Title
SAFETY DATA SHEET
Study date
June 2024
Authorising party
Applicant
Data no
292341
Author
GF Smart
Title
Transplan Fungicide (96095/148156): Chemistry data
Study date
September 2025
Authorising party
Applicant
Data no
285792
Author
H Lu
Title
Manufacturing process for Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
March 2025
Authorising party
Applicant
Data no
285803
Author
S Coster
Title
Evaluation of experimental product, (Fluopyram + Trifloxystrobin) for control of Brown Rot in Stonefruit
Study date
March 2025
Authorising party
Applicant
Data no
309799
Author
GF Smart
Title
REsponse: Transplan Fungicide (96095/148156)
Study date
August 2026
Authorising party
Applicant
Data no
285795
Author
Anon
Title
Certificate of analysis
Study date
November 2024
Authorising party
Applicant
Data no
285804
Author
S Coster
Title
Evaluation of experimental product, (Fluopyram + Trifloxystrobin) for control of Blackspot in Apples
Study date
January 2025
Authorising party
Applicant
Data no
285798
Author
Anon
Title
SAFETY DATA SHEET
Study date
May 2024
Authorising party
Applicant
Data no
309800
Author
H Le
Title
Specification of Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
August 2026
Authorising party
Applicant
Data no
285790
Author
U Gadade
Title
Determination of Low Temperature Storage Stability of Fluopyram 250 g/L + Trifloxystrobin 250 g/L SC
Study date
January 2025
Authorising party
Applicant
Data no
285801
Author
Anon
Title
SAFETY DATA SHEET
Study date
May 2024
Authorising party
Applicant
Data no
292342
Author
Anon
Title
Luna Sensation Fungicide label (65560/58486)
Study date
September 2025
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148381
Product/Active constituent Name

Application Product Name

isoflucypram

Application details

Product name:

isoflucypram

Product number:

96159

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Registration of a 50 g/L isoflucypram EC product for use in cereals for the control of fungicide diseases as per the directions for use table, in conjunction with approval of isoflucypram.

Description of data provided:

Data no
287096
Author
Bongartz, R.; Bartelsen, N.
Title
Amendment no 1 to final report - [Pyrazole-4-14C]BCS-CN88460 - Absorption, distribution, excretion and metabolism in the rat
Study date
04/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287090
Author
Anon
Title
Pesticide residues in food 2022. Joint FAO/WHO meeting on pesticide residues. Evaluation Part II ? Toxicological. Geneva: World Health Organization and Food and Agriculture Organization of the United Nations
Study date
11/04/2024
Authorising party
Public
Auth party contact address
-
Data no
287044
Author
Eyrich, U.; Ziemer, F.
Title
BCS-CN88460, pure substance: Determination of the surface tension
Study date
11/06/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287056
Author
von Glahn, L.; Langenohl, C.
Title
Isoflucypram (BCS-CN88460) - Determination of impurities in technical grade active substance - HPLC - external standard
Study date
22/05/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287104
Author
Dony, E.
Title
BCS-CN88460, technical - Micronucleus assay in bone marrow cells of the mouse
Study date
07/05/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287150
Author
Totis, M.
Title
BCS-CN88460 - Mechanistic 28-day toxicity study in the female rat by dietary administration (hepatotoxicity and thyroid hormone investigations)
Study date
27/09/2013
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287050
Author
Ziemer, F.; Strunk, B.
Title
Isoflucypram (BCS-CN88460), technical substance: Relative density
Study date
05/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287107
Author
Fernyhough, P.; Kendrick, J.
Title
Amendment 1 to [phenyl-UL-14C]BCS-CN88460: Tissue distribution and excretion of radioactivity in the rat by quantitative whole body autoradiography - Amended final report 1
Study date
31/05/2017
Authorising party
Public
Auth party contact address
-
Data no
287084
Author
Majid, H.
Title
Validation of analytical method AM040022MP1 - Determination of BCS-CN45153 in technical isoflucypram (BCS-CN88460) - HPLC-UV external standard
Study date
25/08/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287156
Author
Zelen?k, V.
Title
BCS-CN88460 technical - Acute dermal toxicity study in rats
Study date
29/04/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287133
Author
Repetto, M.
Title
BCS-CN88460 - Preliminary 28-day toxicity study in the mouse by dietary administration
Study date
29/11/2012
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287064
Author
Winkler, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Particle size distribution
Study date
13/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287113
Author
Hueser, A.
Title
Isoflucypram (BCS-CN88460): In silico assessment of the processing metabolite isoflucypram-desmethyl-propanol-aldehyde (BCS-DH85957, M77)
Study date
20/04/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287127
Author
Naumann, S.
Title
BCS-DH85957: Micronucleus test in human lymphocytes in vitro
Study date
13/05/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287076
Author
Ziemer, F.; Strunk, B.
Title
BCS-CV14741 (BCS-CN88460-olefine): Solubility in distilled water (flask method)
Study date
01/10/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287047
Author
Uroic, K.; Peiffer, C.
Title
Spectral data (UV / VIS, IR, 1H-NMR, 13C-NMR, MS) and molar extinction coefficients of BCS-CN88460, pure substance
Study date
21/07/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287070
Author
Frensemeier, L.
Title
Stability to elevated temperature, metals, and metal ions and corrosion characteristics to plastic containers of Isoflucypram (BCS-CN88460)
Study date
15/08/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287093
Author
Blanck, M.
Title
BCS-CN88460 - 90-day toxicity study in the mouse by dietary administration
Study date
12/12/2013
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287116
Author
Kennel, P.
Title
BCS-CN88460 - Chronic toxicity study in the dog by dietary administration
Study date
19/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287139
Author
Shipp, E. B.
Title
Isoflucypram - Justification for not conducting a repeat-dose immunotoxicity study
Study date
19/10/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287041
Author
Wiche, A.; Ziemer, F.
Title
BCS-CN88460, pure substance: Dissociation constant in water
Study date
02/06/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287053
Author
Golka, I.
Title
Validation of the IC analytical method AM050017FP1 - Determination of sodium and potassium in technical grade and pure lsoflucypram (BCS-CN88460) by Ion chromatography (IC)
Study date
28/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287147
Author
Totis, M.
Title
BCS-CN45153 - Exploratory 28-day toxicity study in the rat by dietary administration
Study date
29/06/2011
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287153
Author
V?liczk?, ?.
Title
BCS-CN88460 technical - In vitro eye irritation test in isolated chicken eyes
Study date
13/05/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287130
Author
Renaut, R.
Title
BCS-CN88460 technical: Two generation reproductive performance study by dietary administration to han wistar rats
Study date
16/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287110
Author
Haines, C.
Title
BCS-CN88460: In-vitro inhibition of non-juvenile male HAN Wistar rat thyroperoxidase (tpo)-catalysed guaiacol oxidation
Study date
22/01/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287159
Author
Verkaart, S.
Title
Evaluation of the Estrogen Receptor Agonist and Antagonist Activity of
Isoflucypram (BCS-CN88460) using the Stably Transfected Human Estrogen Receptor-
Transactivation Assay
Study date
20/07/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287087
Author
Adelt, I.
Title
Certificate of Composition - Isoflucypram technical material for Australia - isoflucypram
Study date
05/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287136
Author
Rouquie, D.
Title
BCS-CN88460 - 28-day mechanistic toxicity study for liver and thyroid cell proliferation in female Wistar rats
Study date
22/02/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287067
Author
Dreisch, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Self-reactive Properties (expert statement)
Study date
31/01/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287073
Author
Eyrich, U.; Ziemer, F.
Title
BCS-CY24813 (isoflucypram-propanol): Partition coefficients 1-octanol / water at pH 5, pH 7 and pH 9 (HPLC method)
Study date
17/06/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287048
Author
Eyrich, U.; Ziemer, F.
Title
Isoflucypram (BCS-CN88460), technical substance: The oxidation or reduction properties
Study date
04/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287119
Author
Lasserre, D.
Title
BCS-CN45153 - Evaluation in the immature rat uterotrophic assay coupled with vaginal opening
Study date
10/03/2011
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287071
Author
von Glahn, L.; Peiffer, C.
Title
Isoflucypram (BCS-CN88460) - Determination of technical grade active substance - HPLC - External standard
Study date
07/11/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287142
Author
Sokolowski, A.
Title
BCS-CY26497: Cell mutation assay at the thymidine kinase locus (TK+/-) in mouse lymphoma L5178Y cells
Study date
25/05/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287042
Author
Ziemer, F.; Peschke, C.
Title
BCS-CN88460, pure substance: Solubility in distilled water (column elution method)
Study date
02/06/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287102
Author
Chang, S.
Title
Isoflucypram technical. Code: BCS-CN88460 - Salmonella typhimurium reverse mutation assay
Study date
30/05/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287148
Author
Totis, M.
Title
BCS-CN88460 - Evaluation in the weanling rat Hershberger assay coupled with preputial separation assessment
Study date
07/12/2012
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287131
Author
Renaut, R.
Title
BCS-CN88460 technical: Preliminary study of reproductive performance in the Han Wistar rat by dietary administration
Study date
03/04/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287082
Author
de Carvalho, M. T.
Title
Isoflucypram TC - Determination of corrosivity in metals - Final report
Study date
01/03/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287105
Author
Dony, E.
Title
BCS-CY26497: Micronucleus assay in bone marrow cells of the mouse
Study date
17/12/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287154
Author
Wollny, H. E.
Title
BCS-CN88460, technical: Gene mutation assay in Chinese hamster V79 cells in vitro (V79 / HPRT)
Study date
04/06/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287039
Author
Ziemer, F.; Strunk, B.
Title
BCS-CN88460, pure substance: Determination of the pH-value in distilled water
Study date
02/06/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287088
Author
Adelt, I.
Title
Description of the Manufacturing Process of the technical grade active substance- isoflucypram TC - for Australia
Study date
02/06/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287062
Author
Winkler, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Test for self-heating substances
Study date
13/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287111
Author
Hargitai, J.
Title
BCS-CN88460 technical - Local lymph node assay in the mouse
Study date
05/06/2015
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287125
Author
Naumann, S.
Title
BCS-CY26497: Chromosome aberration test in human lymphocytes in vitro
Study date
06/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287068
Author
Frensemeier, L.
Title
Storage stability of BCS-CN88460 - 2 years
Study date
14/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287091
Author
Anon
Title
Draft assessment report - Evaluation of active substances - Isoflucypram - Volume 1 - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287045
Author
Eyrich, U.; Ziemer, F.
Title
BCS-CN88460, pure substance: Solubility in organic solvents
Study date
17/07/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287051
Author
Ziemer, F.; Strunk, B.
Title
Isoflucypram (BCS-CN88460), technical substance: Determination of the pH-value in distilled water
Study date
05/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287145
Author
Tinwell, H.
Title
Assessment of BCS-CN88460 in the H295R steroidogenesis screen
Study date
14/10/2010
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287151
Author
Verkaart, S.
Title
Isoflucypram (BCS-CN88460): In vitro aromatase inhibition using human recombinant microsomes
Study date
16/07/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287099
Author
Borchers, H.; Heinemann, D.; Doebbe, A.
Title
Document N3 - Substances and metabolites: Structure, codes, synonyms isoflucypram (code: BCS-CN88460) - Stop the clock
Study date
03/04/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287036
Author
Ziemer, F.; Strunk, B.
Title
BCS-CN88460, pure substance: Relative density
Study date
15/04/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287059
Author
Sonnenschein, L.
Title
Isoflucypram (BCS-CN88460), technical substance: Complex formation ability in water according to OECD guideline 108 (polarographic method)
Study date
05/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287108
Author
Garcin, J. C.
Title
BCS-CN88460 - Preliminary 28-day toxicity study in the dog by dietary administration
Study date
27/11/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287134
Author
Richert, L.; Wiss, L.
Title
In vitro CYP and UGT induction in human and Wistar rat hepatocytes by isoflucypram
Study date
21/07/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287085
Author
Majid, H.
Title
Material accountability of isoflucypram (BCS-CN88460) 5 batch analysis
Study date
16/09/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287065
Author
Winkler, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Oxidising properties of solids
Study date
05/01/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287079
Author
Ziemer, F.; Strunk, B.
Title
BCS-DC20298 (Isoflucypram-2-propanol): Partition coefficients 1-octanol / water at pH 5, pH 7 and pH 9 (HPLC method)
Study date
19/03/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287122
Author
McGinnis, C.
Title
BCS-CN88460: In-vitro inhibition of iodide uptake by sodium/iodide symporter in the rat thyroid-derived cell line FRTL-5
Study date
21/01/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287128
Author
Odin, M.
Title
BCS-CN88460 - 90-day toxicity study in the rat by dietary administration
Study date
17/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287094
Author
Blanck, M.
Title
BCS-CN88460 - Carcinogenicity study in the C57BL/6J mouse by dietary administration
Study date
27/06/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287117
Author
Kennel, P.
Title
BCS-CN88460 - Developmental toxicity study in the rat by gavage
Study date
29/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287140
Author
Shipp, E. B.
Title
Isoflucypram - Tabulation of integrated lines of evidence regarding E, A, S, and T modalities for potential endocrine activity
Study date
05/12/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287054
Author
Golka, I.; Eckert, J.
Title
Analytical method - Determination of chloride and fluoride in pure and technical grade isoflucypram (BCS-CN88460) by ion chromatography
Study date
01/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287146
Author
Tinwell, H.
Title
Assessment of BCS-CN45153 in the H295R steroidogenesis screen
Study date
24/11/2009
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287100
Author
Breckenridge, C.
Title
Evaluation of evidence for a maximum tolerated dose in the chronic rat study on isoflucypram
Study date
30/03/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287060
Author
Wagner, S.
Title
Spectral data (UV / VIS, IR, 1H-NMR, 13C-NMR, MS) and molar extinction coefficients of BCS-CN45153
Study date
07/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287129
Author
Odin, M.
Title
BCS-CN88460: Chronic toxicity and carcinogenicity study in the Wistar rat by dietary administration
Study date
14/02/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287037
Author
Ziemer, F.; Peschke, C.
Title
BCS-CN88460, pure substance: Partition coefficients 1-octanol / water at pH 4, pH 7 and pH 9 (HPLC method)
Study date
22/04/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287086
Author
Adelt, I.
Title
Discussion of Formation of impurities - isoflucypram technical active substance - For Australia
Study date
06/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287066
Author
Dreisch, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Explosive properties
Study date
15/01/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287080
Author
von Glahn, L.
Title
Validation of analytical method AM029617MP3 - Determination of impurities in technical isoflucypram (BCS-CN88460) - HPLC-UV external standard
Study date
31/03/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287074
Author
Wiche, A.; Ziemer, F.
Title
BCS-DC22055 (BCS-CN88460-desmethyl-propanol): Dissociation constant in water
Study date
04/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287123
Author
Mosbey, J.
Title
Part 3 Summary of Toxicology on the active substance Isoflucypram
Study date
30/5/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287143
Author
Spohr, C.
Title
Isoflucypram technical: Cytotoxicity assay in vitro with BALB/c 3T3 Cells: Neutral red (NR) test during simultaneous irradiation with artificial sunlight
Study date
28/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287120
Author
Leconte, I.
Title
BCS-CN88460 - Developmental toxicity study in the rabbit by gavage
Study date
15/05/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287137
Author
Rouquie, D.
Title
BCS-CN88460 - 7-day mechanistic toxicity study for liver and thyroid cell proliferation in female Wistar rats
Study date
22/02/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287149
Author
Totis, M.
Title
BCS-CN88460 - Exploratory 28-day toxicity study in the rat by dietary administration
Study date
15/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287103
Author
Chang, S.
Title
BCS-DH85957 - Salmonella typhimurium reverse mutation assay
Study date
14/06/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287043
Author
Ziemer, F.
Title
BCS-CN88460: Calculation of the Henry's law constant
Study date
10/06/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287097
Author
Bongartz, R.; Bartelsen, N.
Title
Amendment no 1: [Phenyl-UL-14C]BCS-CN88460 - Absorption, distribution, excretion and metabolism in the rat
Study date
26/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287083
Author
Majid, H.; Buhl, W.
Title
Isoflucypram (BCS-CN88460) - Determination of BCS-CN45153 in technical grade active substance - HPLC - external standard
Study date
8/08/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287106
Author
EFSA
Title
Peer review of the pesticide risk assessment of the active substance isoflucypram
Study date
23/06/2022
Authorising party
Public
Auth party contact address
-
Data no
287057
Author
Bowen, T.
Title
Validation of GC method AM050117FP1: Determination of the organic solvents AE 0171910, AE F157470 and BCS-AA10447 in isoflucypram (BCS-CN88460) technical grade and pure active substance by gas chromatography (GC)
Study date
06/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287063
Author
Winkler, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Melting point, boiling point, thermal stability
Study date
13/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287040
Author
Dreisch, S.
Title
BCS-CN88460, pure substance: Vapour pressure
Study date
28/05/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287157
Author
Zelen?k, V.
Title
BCS-CN88460 technical - Acute oral toxicity study in the rat (up and down procedure)
Study date
12/05/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287077
Author
Wiche, A.; Ziemer, F.
Title
BCS-CX99799 (BCS-CN88460-desmethyl-carboxylic acid): Dissociation constant in water
Study date
07/10/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287114
Author
Kennel, P.
Title
BCS-CN88460 - Evaluation in the immature rat uterotrophic assay coupled with vaginal opening
Study date
05/05/2011
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287126
Author
Naumann, S.
Title
BCS-CY26497: Salmonella typhimurium reverse mutation assay
Study date
06/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287144
Author
Steffens, W.
Title
Summary of medical data known for isoflucypram
Study date
26/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287138
Author
Shipp, E.
Title
Isoflucypram - Weight-of-evidence-based assessment of the endocrine disrupting potential of isoflucypram
Study date
23/10/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287092
Author
Anon
Title
Assessment Report - Evaluation of Active Substances - Isoflucypram - Volume 3 - B.6 (AS) - Toxicology & Metabolism Data - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287152
Author
Verkaart, S.
Title
Evaluation of the androgen receptor agonist and antagonist activity of isoflucypram (BCS-CN88460) using the stably transfected human androgen receptor transcriptional activation assay (AR-EcoScreen?)
Study date
20/07/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287046
Author
Uroic, K.
Title
Composition and spectral data set of BCS-CN88460
Study date
01/12/2015
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287052
Author
Golka, I.
Title
Amendment no. 1: Validation of the IC analytical method AM049917FP1 - Determination of chloride and fluoride in technical grade and pure - lsoflucypram (BCS-CN88460) by Ion chromatography (IC)
Study date
14/09/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287098
Author
Bongartz, R.; Bartelsen, N.
Title
Amendment no. 1: [Pyrazolyl-4-14C]BCS-CY26497: Pilot metabolism experiments in male rats
Study date
25/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287158
Author
Zelen?k, V.
Title
BCS-CN88460 technical - Acute eye irritation study in rabbits
Study date
29/07/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287058
Author
Schaefer, C.; Bowen, T.
Title
Determination of AE 0171910, AE F157470 and BCS-AA10447 in BCS-CN88460 technical grade active substance by gas chromatography (GC)
Study date
06/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287035
Author
Ziemer, F.; Strunk, B.
Title
BCS-CN88460, pure substance: Physical characteristics colour, physical state and odour
Study date
07/04/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287109
Author
Garcin, J. C.
Title
BCS-CN88460 - An acute neurotoxicity study in the rat by oral administration
Study date
05/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287135
Author
Rouquie, D.
Title
BCS-CN88460 - Mechanistic 7-day toxicity study for liver and thyroid cell proliferation in the C57BL/6J female mouse
Study date
18/11/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287078
Author
von Glahn, L.; Langenohl, C.
Title
Validation of AM031318MP1 - Isoflucypram (BCS-CN88460) - Determination of technical grade active substance - HPLC External standard
Study date
01/10/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287115
Author
Kennel, P.
Title
BCS-CN88460: 90-Day toxicity study in the dog by dietary administration
Study date
05/05/2015
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287121
Author
Letamendia, L.
Title
BCS-CN88460, BCS-CX99799, BCS-CX99798, BCS-CY26497: Assessment of gene expression profiles of phase I and phase II liver enzymes in primary cultures of rat hepatocytes
Study date
19/12/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287072
Author
von Glahn, L.
Title
Storage stability of isoflucypram (BCS-CN88460) - 3 years
Study date
18/12/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287095
Author
Bohnenberger, S.
Title
BCS-CN88460, technical: Chromosome aberration test in human lymphocytes in vitro
Study date
23/07/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287118
Author
Lagojda, A.; Doebbe, A.
Title
[Pyrazole-4-14C]BCS-CN88460 - Metabolic stability and profiling in liver microsomes from different animals and humans for inter-species comparison
Study date
24/08/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287141
Author
Sokolowski, A.
Title
BCS-CN88460; technical: Salmonella typhimurium reverse mutation assay
Study date
19/05/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287089
Author
Mosbey, J.
Title
Part 2 ? Chemistry and manufacturing data for approval of a new active constituent
Study date
30/5/25
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287101
Author
Chang, S.
Title
Isoflucypram, technical, Code: BCS-CN88460 - Salmonella typhimurium reverse mutation assay
Study date
09/12/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287055
Author
Golka, I.; G?nther, S.
Title
Analytical method - Determination of sodium and potassium in pure and technical grade isoflucypram (BCS-CN88460) by ion chromatography
Study date
01/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287049
Author
Ziemer, F.; Strunk, B.
Title
Isoflucypram (BCS-CN88460), technical substance: Physical characteristics colour, physical state and odour
Study date
05/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287155
Author
Zelen?k, V.
Title
BCS-CN88460 technical - Acute skin irritation study in rabbits
Study date
18/04/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287132
Author
Repetto, M.
Title
BCS-CN45153 - Preliminary 28-day toxicity study in the mouse by dietary administration
Study date
16/11/2010
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287081
Author
Wieser, L; Althoff, A.
Title
Standard method water determination in technical active substances according to CIPAC MT 30.6 by Karl Fischer Method - Volumetric titration
Study date
10/11/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287038
Author
Krack, M.
Title
BCS-CN88460, pure substance: Melting point, boiling point, thermal stability
Study date
05/05/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287112
Author
Hilmi, C.
Title
BCS-CN45153 - Assessment in the in vitro micronucleus and mutagenicity preliminary screens
Study date
14/04/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287061
Author
Winkler, S.
Title
Isoflucypram (BCS-CN88460), technical substance: Flammability (solids)
Study date
13/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287069
Author
Adelt, I.
Title
Statement regarding the relevant impurity / in isoflucypram formulations
Study date
12/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287075
Author
Eyrich, U.; Ziemer, F.
Title
BCS-CY24813 (isoflucypram-propanol): Water solubility at pH 5, pH 7 and pH 9 (flask method)
Study date
11/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287124
Author
M?ty?s, A.
Title
BCS-CN88460 technical - Acute inhalation toxicity study (nose-only) in the rat
Study date
17/11/2014
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date

Application Date

Application No

Application Number

148382
Product/Active constituent Name

Application Product Name

Vimoy Iblon 50 EC Fungicide

Application details

Product name:

Vimoy Iblon 50 EC Fungicide

Product number:

96160

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Registration of a 50 g/L isoflucypram EC product for use in cereals for the control of fungicide diseases as per the directions for use table, in conjunction with approval of isoflucypram.

Description of data provided:

Data no
287190
Author
Zelen?k, V.
Title
BCS-CN88460 EC 50 - Acute eye irritation study in rabbits
Study date
20/01/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289489
Author
Bogacki, P.
Title
Efficacy of Input Xpro and Vimoy Iblon for Net form net blotch control in barley
Study date
16/06/2025
Authorising party
Public
Auth party contact address
-
Data no
287167
Author
Anon.
Title
Draft assessment report - Evaluation of active substances - Isoflucypram - Volume 1 - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286025
Author
APVMA
Title
Project plan Item 27 timeshift
Study date
06/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286002
Author
Sekine, T.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory
Study date
03/08/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286008
Author
L?hrs, U.; Schneider, C.
Title
Isoflucypram + prothioconazole EC200: Acute toxicity to rainbow trout (Oncorhynchus mykiss) in a 96-hour semi-static test
Study date
05/10/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289228
Author
Harbin, A. M.
Title
BCS-CN88460: Magnitude of residues in/on wheat processed fractions following treatment with BCS-CN88460 EC50
Study date
04/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289251
Author
Lamshoeft, M.; Bartelsen, N.
Title
Nature of the residues of [pyrazole-4-14C]BCS-CY24813 in processed commodities - High temperature hydrolysis
Study date
19/02/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287196
Author
Hoppe, M.
Title
Physical, chemical and technical properties of BCS-CN88460 EC 50 (50 g/L)
Study date
15/09/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
306383
Author
Adelt, I.
Title
Discussion of Formation of impurities - isoflucypram technical active substance - For Australia
Study date
29/5/2026
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309632
Author
B ttner, G.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Acute toxicity to earthworms (Eisenia fetida) tested in artificial soil
Study date
20/12/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285962
Author
Larnaudie Lopez, M. I.
Title
BCS-CN88460 EC 50 G: Influence on mortality and reproduction of the soil mite species Hypoaspis aculeifer tested in artificial soil
Study date
09/06/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289257
Author
Rogers, D.
Title
Determination of isoflucypram residues in wheat and triticale following applications of Vimoy Iblon (sp102000037709)
Study date
12/06/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285971
Author
K?hler, P.
Title
Effects on the seedling emergence and growth of four species of non-target terrestrial plants (Tier 2) Isoflucypram EC 50 g/L
Study date
15/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286014
Author
Ruhland, S.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Chronic toxicity to the honey bee Apis mellifera L. under laboratory conditions
Study date
27/01/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289506
Author
Hall, G.
Title
Vimoy Iblon + PTZ for control of leaf scald in barley
Study date
28/03/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289512
Author
Murray, R., Fuhrmann, K., Bosveld, D. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of Septoria tritici blotch in wheat
Study date
28/2/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309626
Author
K hler, P.
Title
Effects on the seedling emergence and growth of four species of non-target terrestrial plants (Tier 2) Isoflucypram EC 50 g/L
Study date
15/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285968
Author
Kuhl, K.
Title
Pseudokirchneriella subcapitata growth inhibition test - BCS-CN88460 EC50 G
Study date
15/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289477
Author
Tyson, P.
Title
Vimoy Iblon + prothioconazole for control of Puccinia striiformis (stripe rust) in wheat
Study date
22/04/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289220
Author
Lagojda, A; Mueller, M
Title
Metabolism of [pyrazole-4-14C]-BCS-CN88460 in wheat plants, identification of unknown metabolites
Study date
10/05/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289503
Author
Poole, N., Murray, R., Morris, B. and Price, T.
Title
Efficacy of Input Xpro and Vimoy Iblon for the control of powdery mildew in barley
Study date
04/03/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289497
Author
Frost, P.
Title
Efficacy of Vimoy Iblon 050 EC and BCS-CN88460 200 SC with and without Brumby 480 SC against net form net blotch (Pyrenophora teres f. teres) and leaf scald (Rhynchosporium secalis) in barley cv. Minotaur
Study date
02/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285951
Author
Anon
Title
SDS all
Study date
30/4/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289248
Author
Botterweck, J.
Title
Metabolism of [pyrazole-4-14C]-BCS-CN88460 in oilseed rape
Study date
20/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285988
Author
Mingo, V.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Toxicity to the rainbow trout Oncorhynchus mykiss under laboratory conditions (acute toxicity test - Semi-static)
Study date
29/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289234
Author
Glaubitz, J.
Title
Amendment no. 1: BCS-CN88460: Feeding study with dairy cows
Study date
11/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287170
Author
Anon.
Title
Conclusion of the assessing competent authority on the active substance isoflucypram - Great Britain
Study date
01/06/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287176
Author
Kennel, P.
Title
BCS-CN88460 - Chronic toxicity study in the dog by dietary administration
Study date
29/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285994
Author
Persdorf, M.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on the activity of soil microflora (carbon transformation test)
Study date
15/10/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289240
Author
Harbin, A. M.
Title
BCS-CN88460 EC50: Magnitude of the residues in/on leafy vegetables rotational crops (spinach)
Study date
22/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289483
Author
Ryan, C.
Title
Input Xpro and Vimoy Iblon for yellow leaf spot control in wheat
Study date
02/04/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289254
Author
Tobias, S.
Title
Metabolism of [pyrazole-4-14C]BCS-CN88460 in wheat after seed treatment
Study date
06/04/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289231
Author
Bongartz, R.; Doebbe, A.; Conrad, F.
Title
[Phenyl-UL-14C]BCS-CN88460: Metabolism in the laying hen
Study date
21/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287187
Author
Rosos-Matting, E.
Title
BCS-CN88460 EC 50 - Acute inhalation toxicity study (Nose-only) in the rat
Study date
07/03/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285959
Author
Waibel, J.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi (Hymenoptera: Braconidae) using an extended laboratory test on barley BCS-CN88460 EC 50 g/L
Study date
17/03/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285982
Author
Sekine, T.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory
Study date
16/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286005
Author
Friedemann, A.; Schwarz, E.
Title
Effects of isoflucypram + prothioconazole EC 200 (50 + 150 g/L) on vegetative vigour of ten non-target terrestrial plant species under greenhouse conditions (Tier 1)
Study date
09/08/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286022
Author
Anon.
Title
Conclusion of the assessing competent authority on the active substance isoflucypram - Great Britain
Study date
01/06/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309629
Author
Appl, .
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Acute oral toxicity study in rats (up and down procedure)
Study date
03/03/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285974
Author
M?ller, R. U.
Title
Toxicity to the ladybird beetle Coccinella septempunctata (Coleoptera: Coccinellidae) using an extended laboratory test on bean BCS-CN88460 EC 50 g/L
Study date
28/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286011
Author
Schmidt, K.
Title
Amendment no. 01: Isoflucypram + prothioconazole EC 200 (50+150 g/L) - Repeated exposure of honey bee larvae (Apis mellifera L.) under laboratory conditions
Study date
22/12/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287193
Author
Anon
Title
SDS all
Study date
30/04/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287199
Author
Michel, A; Garcia Sanchez, M. T.
Title
Validation of Analytical Method AM027115MF2 - Determination of isoflucypram in the formulation isoflucypram EC 50 (50 g/L) - Final Report -
Study date
27/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285965
Author
Kuhl, K.
Title
BCS-CN88460 EC 50 G acute toxicity to rainbow trout (Oncorhynchus mykiss) under static conditions
Study date
07/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289509
Author
Wilson-Kerrigan, T.
Title
Efficacy of Vimoy Iblon for control of Pyrenophora teres f. maculata (spot form of net blotch) in barley; (Dalyup, WA)
Study date
13/1/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287202
Author
G?ldner, W.
Title
Shelf life of BCS-CN88460 EC 50 (50 g/L) - Packaging material: COEX/EVOH - Final report (2 years)
Study date
20/09/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289480
Author
Ryan, C.
Title
Vimoy Iblon + PTZ for control of stripe rust in wheat
Study date
06/03/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
306386
Author
Mosbey, J.
Title
Vimoy iblon 50 EC Fungicide draft label
Study date
14/6/2026
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287179
Author
Kov?cs, M.
Title
BCS-CN88460 EC 50 - In vitro eye irritation test in isolated chicken eyes
Study date
30/05/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289500
Author
Bates, N.
Title
Vimoy Iblon + PTZ for control of leaf rust in barley
Study date
19/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285985
Author
Larnaudie Lopez, M. I.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Influence on mortality and reproduction of the soil mite species Hypoaspis aculeifer tested in artificial soil
Study date
22/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285991
Author
Richter, A.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on survival, growth and reproduction of the earthworm Eisenia fetida tested in artificial soil
Study date
05/09/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289237
Author
Traub, M.
Title
Amendment no.1 to final report - Metabolism of [phenyl-UL-14C] BCS-CN88460 in wheat plants
Study date
16/01/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289486
Author
Poole, N., Wylie, T., Warren, D. and Bosveld, D.
Title
Efficacy of Input Xpro and Vimoy Iblon for leaf rust control in wheat
Study date
22/02/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287173
Author
Blanck, M.
Title
BCS-CN88460 EC 50 [14C]-BCS-CN88460 - In vitro dermal absorption study using human skin
Study date
28/04/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287165
Author
Anon
Title
Assessment Report - Evaluation of Active Substances - Isoflucypram - Volume 3 - B.6 (AS) - Toxicology & Metabolism Data - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289255
Author
Wadanamby, D.
Title
Determination of isoflucypram residues in winter cereals following applications of Vimoy Iblon
Study date
08/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289232
Author
Bongartz, R.; Bartelsen, N.
Title
Amendment no 1 to final report - [Pyrazole-4-14C]BCS-CN88460 - Absorption, distribution, excretion and metabolism in the rat
Study date
04/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285954
Author
M?ty?s, A.
Title
BCS-CN88460 EC 50 - Acute oral toxicity study in male and female rats
Study date
08/07/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285960
Author
K?hler, P.
Title
Amendment no. 01: BCS-CN88460 EC 50 g/L - Effects on the vegetative vigor of ten species of non-target terrestrial plants
Study date
10/07/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285977
Author
Reinken, G.; Kallweit, W.
Title
Isoflucypram (ISY) and metabolite: PECsoil EUR - Use in cereals in Europe
Study date
27/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285983
Author
Ripperger, D.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on the vegetative vigour of ten non-target terrestrial plant species (tier 1)
Study date
18/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287188
Author
Stuke, S.; Daniels, M.; van Berkum, S.
Title
Determination of the dislodgeable foliar residues (DFR) of BCS-CN88460 in/on barley after spray application of BCS-CN88460 EC 050 in Germany
Study date
09/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286006
Author
Bebon, R.; Schneider, C.
Title
Isoflucypram + prothioconazole EC200 - Acute toxicity to Daphnia magna in a semi-static 48-hour immobilisation test
Study date
22/09/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289249
Author
Botterweck, J.
Title
Metabolism of [phenyl-UL-14C]-BCS-CN88460 in oilseed rape
Study date
20/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289495
Author
Shelley, J.
Title
Vimoy Iblon + PTZ for control of powdery mildew and net form net blotch in barley
Study date
25/03/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289226
Author
Lamshoeft, M.
Title
Metabolism of [pyrazole-4-14C]BCS-CN88460 in tomato
Study date
24/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286023
Author
Mosbey, J.
Title
Part 7 Environment for Vimoy Iblon 50 EC Fungicide
Study date
02/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309630
Author
L hrs, U.; Schneider, C.
Title
Isoflucypram + prothioconazole EC200: Acute toxicity to rainbow trout (Oncorhynchus mykiss) in a 96-hour semi-static test
Study date
05/10/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285966
Author
Koehler, P.
Title
BCS-CN88460 EC 50 g/L - Effects on the seedling emergence and growth of ten species of non-target terrestrial plants (tier 2)
Study date
10/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287194
Author
Michel, A.
Title
Determination of isoflucypram in formulations - Assay - HPLC, external standard
Study date
02/05/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286017
Author
Waibel, J.
Title
Toxicity to the ladybird beetle Coccinella septempunctata (Coleoptera: Coccinellidae) using an extended laboratory test on maize; isoflucypram + prothioconazole EC 200 (50+150 g/L)
Study date
07/02/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309624
Author
M ty s, A.
Title
BCS-CN88460 EC 50 - Acute oral toxicity study in male and female rats
Study date
08/07/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289501
Author
Tyson, P.
Title
Vimoy Iblon + prothioconazole for control of Pyrenophora teres f.sp. teres (net form net blotch) in barley
Study date
22/04/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287205
Author
Fitzgerald, M.
Title
Manufacturing procedure - Plant protection product for Australia - isoflucypram EC 50 (50 g/L) - Vimoy Iblon 50 EC Fungicide
Study date
20/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287182
Author
Mosbey, J.
Title
Part 3 - Toxicology Vimoy Iblon 50 EC Fungicide
Study date
30/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289475
Author
Bogacki, P.
Title
Efficacy of Input Xpro and Vimoy Iblon for Septoria tritici control in wheat
Study date
16/06/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286000
Author
Schulz, L.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on the activity of soil microflora (carbon transformation test)
Study date
09/07/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289246
Author
Traub, M.
Title
Metabolism of [pyrazole-4-14C]-BCS-CN88460 in soybean plants
Study date
27/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285986
Author
Richter, A.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Acute toxicity to earthworms (Eisenia fetida) tested in artificial soil
Study date
23/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289481
Author
Jackman, R.
Title
Vimoy Iblon + PTZ for control of stripe rust in wheat
Study date
03/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287174
Author
Buerling, K.; Baumann, J.; Shipp, E.
Title
Summary of the toxicological studies for isoflucypram EC 50 (50 g/L) (Code: BCS-CN88460 EC 50)
Study date
14/04/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285957
Author
Frommholz, U.
Title
BCS-CN88460 EC 50 G: Effects on survival, growth and reproduction of the earthworm Eisenia fetida tested in artificial soil
Study date
13/12/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289229
Author
Harbin, A. M.
Title
BCS-CN88460 EC50: Magnitude of the residues in/on small grain rotational crops (wheat)
Study date
06/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287168
Author
Anon.
Title
Draft assessment report - Evaluation of active substances - Isoflucypram - Volume 3 - B.6 (PPP) - Isoflucypram EC 50 - Toxicology, metabolism data & assessment of risks for humans - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289492
Author
Lydon, J.
Title
Vimoy Iblon + PTZ for control of net form net blotch (Pyrenophora teres f.sp. teres) in barley
Study date
13/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287191
Author
Zelen?k, V.
Title
BCS-CN88460 EC 50 - Acute skin irritation study in rabbits
Study date
27/01/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289515
Author
Poole, N., Wylie, T., Warren, D. and Vague, A.
Title
Efficacy of Input Xpro and Vimoy Iblon for Septoria tritici control in wheat
Study date
31/01/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286026
Author
Ciolek, R.
Title
Permit to import conditionally non-prohibited goods
Study date
17/11/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286003
Author
Richter, A.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Influence on mortality and reproduction of the soil mite species Hypoaspis aculeifer tested in artificial soil
Study date
24/08/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289252
Author
Lagojda, A.
Title
Metabolism of [pyrazole-4-14C]BCS-CN88460 in wheat after seed treatment - Amendment no. 2 to final phase report S19-06374-L2 - Identification of unknown metabolites phase
Study date
06/10/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285980
Author
Blank, M.; Gladbach, A.
Title
Summary of the ecotoxicological studies - Isoflucypram EC 50 (50 g/L)
Study date
02/05/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287185
Author
M?ty?s, A.
Title
BCS-CN88460 EC 50 - Acute oral toxicity study in male and female rats
Study date
08/07/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285963
Author
Waibel, J.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi (Hymenoptera: Braconidae) using a laboratory test BCS-CN88460 EC 50 g/L
Study date
23/06/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287208
Author
Mosbey, J.
Title
Part 2 ? Chemistry and manufacturing data for approval of a new active constituent
Study date
30/5/25
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289223
Author
Lamshoeft, M.
Title
Metabolism of [pyrazole-4-14C]BCS-CN88460 in confined rotational crops - Amendment no. 2 to final report
Study date
28/06/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286009
Author
B?ttner, G.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on survival, growth and reproduction of the earthworm Eisenia fetida tested in artificial soil
Study date
18/10/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
306384
Author
Adelt, I.
Title
Description of the Manufacturing Process of the technical grade active substance- isoflucypram TC - for Australia
Study date
8/6/2026
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286020
Author
Anon.
Title
Draft assessment report - Evaluation of active substances - Isoflucypram - Volume 3 - B.8 (PPP) - Isoflucypram EC 50 - Environmental fate & behaviour - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309627
Author
M ller, R. U.
Title
Toxicity to the ladybird beetle Coccinella septempunctata (Coleoptera: Coccinellidae) using an extended laboratory test on bean BCS-CN88460 EC 50 g/L
Study date
28/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285969
Author
Waibel, J.
Title
Toxicity to the green lacewing Chrysoperla carnea (Neuroptera: Chrysopidae) using an extended laboratory test on bean - BCS-CN88460 EC 50 g/L
Study date
18/09/2017
Authorising party
Public
Auth party contact address
-
Data no
289243
Author
Glaubitz, J.; Fichant, E.
Title
BCS-CN88460: Feeding study with laying hens
Study date
07/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289504
Author
Hunt, J.
Title
Vimoy Iblon + PTZ for control of spot form net blotch in barley
Study date
13/03/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289478
Author
MacLennan, A.
Title
Vimoy Iblon + Prothioconazole (Proline) for control of stripe rust in wheat
Study date
23/04/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289498
Author
Cocoma, D.
Title
Vimoy Iblon + PTZ for control of leaf rust in barley
Study date
27/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289235
Author
Bongartz, R.; Doebbe, A.; Luks, A.-K.; Conrad, F.
Title
[Pyrazole-4-14C]BCS-CN88460 - Metabolism in the lactating goat
Study date
18/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285997
Author
Appl, ?.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Acute oral toxicity study in rats (up and down procedure)
Study date
03/03/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285989
Author
Waibel, J.
Title
Toxicity to the green lacewing Chrysoperla carnea (Neuroptera: Chrysopidae) using an extended laboratory test on bean; isoflucypram + prothioconazole EC 200 (50 + 150 g/L)
Study date
23/08/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287171
Author
Bernal, J.
Title
In-vivo rat skin penetration of 14C-BCS-CN88460 (isoflucypram) in ISY EC 50 test item
Study date
19/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289484
Author
Brown, J.
Title
Input Xpro and Vimoy Iblon for yellow leaf spot control in wheat
Study date
25/06/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285981
Author
Waibel, J.
Title
Toxicity to the predatory mite Typhlodromus pyri (Acari: Phytoseiidae) using an extended laboratory test on bean; isoflucypram + prothioconazole EC 200 (50 + 150 g/L)
Study date
22/11/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289230
Author
Bongartz, R.; Luks, A. K.; Conrad, F.
Title
[Pyrazole-4-14C]BCS-CN88460: Metabolism in the laying hen
Study date
21/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285958
Author
Hein, R.
Title
Assessment of side effects of BCS-CN88460 EC 50 on the honeybee (Apis mellifera L.) in the semi-field after one application on Phacelia tanacetifolia in Germany 2016
Study date
01/03/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289516
Author
Anstis, S.
Title
Input Xpro and Vimoy Iblon for stripe rust control in wheat
Study date
13/11/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289493
Author
Murray, R., Bloomfield, M., Fuhrmann, K. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of net form net blotch in barley
Study date
07/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287186
Author
Odin, M.
Title
BCS-CN88460 - 90-day toxicity study in the rat by dietary administration
Study date
17/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286004
Author
Friedemann, A.; Schwarz, E.
Title
Effects of isoflucypram + prothioconazole EC 200 (50 + 150 g/L) on seedling emergence and seedling growth of ten non-target terrestrial plant species under greenhouse conditions (Tier 1)
Study date
09/08/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285975
Author
Waibel, J.
Title
Toxicity to the predatory mite Typhlodromus pyri (Acari: Phytoseiidae) using a laboratory test on bean BCS-CN88460 EC 50 g/L
Study date
04/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289224
Author
Lamshoeft, M.; Mueller, M.
Title
Metabolism of [phenyl-UL-14C]BCS-CN88460 in confined rotational crops
Study date
19/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286012
Author
B?ttner, G.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Acute toxicity to earthworms (Eisenia fetida) tested in artificial soil
Study date
20/12/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286021
Author
Jans, D.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi using an extended laboratory test with aged residues on maize; isoflucypram + prothioconazole EC 200 (50+150 g/L)
Study date
22/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287200
Author
Schulz, F.; Jasak, J.
Title
Determination of impurity BCS-CN45153 in formulations containing isoflucypram - Assay - HPLC-MS/MS, external standard
Study date
16/01/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289510
Author
Murray, R., Warren, D., Bosveld, D., Bloomfield, M. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of spot form of net blotch in barley
Study date
24/01/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289479
Author
Vague, A., Warren, D., Bosveld, D., Bloomfield, M. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of stripe rust in wheat
Study date
07/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287180
Author
Kov?cs, M.
Title
BCS-CN88460 EC 50 - In vitro skin corrosivity test in the EPISKIN (SM) model
Study date
08/08/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287203
Author
G?ldner, W.
Title
Shelf life of BCS-CN88460 EC 50 (50 g/L) - Packaging material: COEX/PA - Final report (2 years)
Study date
20/09/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289244
Author
Miller, A.
Title
Independent laboratory validation of residue analytical method 01511 for the determination of residues of BCS-CN88460 and its metabolites BCS-DC20298, BCS-CY26497, BCS-CY24813, BCS-DC22055 and BCS-CX99799 in/on animal tissues, milk and eggs by HPLC-MS/MS
Study date
09/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289499
Author
Cocoma, D.
Title
Vimoy Iblon + PTZ for control of leaf rust in barley
Study date
27/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285998
Author
Wendling, K.
Title
Isoflucypram + prothioconazole EC 200 (50 + 150 g/L): Honey bee (Apis mellifera L.) 22 day larval toxicity test (Repeated exposure)
Study date
15/01/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289487
Author
Murray, R., Bosveld, D, Das, D. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of yellow leaf spot in wheat
Study date
07/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285992
Author
Waibel, J.
Title
Toxicity to the ladybird beetle Coccinella septempunctata (Coleoptera: Coccinellidae) using an extended laboratory test on bean; isoflucypram + prothioconazole EC 200 (50 + 150 g/L)
Study date
12/09/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289238
Author
Traub, M.
Title
Amendment no.1 to final report - Metabolism of [pyrazole-4-14C] BCS-CN88460 in wheat plants
Study date
16/01/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309625
Author
K hler, P.
Title
Amendment no. 01: BCS-CN88460 EC 50 g/L - Effects on the vegetative vigor of ten species of non-target terrestrial plants
Study date
10/07/2020
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287189
Author
Stuke, S.; Daniels, M.; van Berkum, S.
Title
Determination of the dislodgeable foliar residues (DFR) of BCS-CN88460 in/on barley after spray application of BCS-CN88460 EC 050 in Portugal
Determination of the dislodgeable foliar residues (DFR) of BCS-CN88460 in/on barley after spray application of BCS-CN88460 EC 050 in Portugal
Study date
09/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289513
Author
Murray, R., Price, T., Morris, B. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of Septoria tritici blotch in wheat
Study date
24/01/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287166
Author
Anon.
Title
Pesticide residues in food 2022. Joint FAO/WHO meeting on pesticide residues. Evaluation Part II ? Toxicological. Geneva: World Health Organization and Food and Agriculture Organization of the United Nations
Study date
11/04/2024
Authorising party
Public
Auth party contact address
-
Data no
289490
Author
Poole, N., Mackenzie, S., Warren, D. and Vague, A.
Title
Efficacy of Input Xpro and Vimoy Iblon for Spot form net blotch control in barley
Study date
22/02/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285978
Author
Reinken, G.; Kallweit, W.
Title
Isoflucypram (ISY) and metabolite: PECgw FOCUS PEARL, PELMO, MACRO EUR - Use in winter cereals and spring cereals in Europe
Study date
08/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285984
Author
Ripperger, D.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on the seedling emergence and growth of ten non-target terrestrial plant species (tier 1)
Study date
18/07/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289227
Author
Glaubitz, J.; Kuppels, U.; Eickstaedt, D.
Title
Residue analytical method 01511 for the determination of residues of BCS-CN88460 and its metabolites BCS-DC20298, BCS-CY26497, BCS-CY24813, BCS-DC22055 and BCS-CX99799 in/on animal tissues, milk and eggs by HPLC-MS/MS
Study date
21/08/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286001
Author
Schulz, L.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on the activity of soil microflora (nitrogen transformation test)
Study date
09/07/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285955
Author
Ehmke, A.
Title
BCS-CN88460 EC 50 (50.0 g/L): Effects (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory
Study date
16/11/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289250
Author
Stuke, S.
Title
Storage stability of BCS-DC22055 and BCS-CY24813 in wheat (grain, green material, straw) for 30 months - Final report
Study date
31/08/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289496
Author
Murray, R., Morris, B., Price, T. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of stripe rust in wheat
Study date
13/1/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286024
Author
Mosbey, J.
Title
Part 7 Environment supplemental for Vimoy Iblon 50 EC Fungicide
Study date
30/04/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289258
Author
Mosbey, J.
Title
Part 5 ? Residues and Trade: isoflucypram in cereals
Study date
4/7/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285961
Author
Larnaudie Lopez, M. I.
Title
BCS-CN88460 EC 50 G: Influence on mortality and reproduction of the collembolan species Folsomia candida tested in artificial soil
Study date
08/06/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285972
Author
Vallon, A.
Title
Assessment of side-effects of isoflucypram EC 50 G on the honeybee (Apis mellifera L.) in a semi-field study after application in flowering Phacelia tanacetifolia in Spain 2017
Study date
24/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286015
Author
Waibel, J.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi (Hymenoptera: Braconidae) using an extended laboratory test on barley; isoflucypram + prothioconazole EC 200 (50+150 g/L)
Study date
07/02/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286018
Author
Anon.
Title
Draft assessment report - Evaluation of active substances - Isoflucypram - Volume 3 - B.9 (PPP) - Isoflucypram EC 50 - Ecotoxicology - Great Britain
Study date
01/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289507
Author
Murray, R., Price, T., Morris, B. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of powdery mildew in wheat
Study date
07/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287197
Author
Gueldner, W.; Hoppe, M.
Title
Storage stability at elevated temperature and cold stability of BCS-CN88460 EC 50 (50 g/L) - Packaging material: COEX/PA - Final report (14 days)
Study date
14/12/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289241
Author
Harbin, A. M.
Title
BCS-CN88460 EC50: Magnitude of the residues in/on root rotational crops (turnip)
Study date
16/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287177
Author
Kanizsai, B.
Title
BCS-CN88460 EC 50 - Local lymph node assay in the mouse
Study date
28/07/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289221
Author
Lagojda, A.; Kasel, D.
Title
Metabolism of [pyrazole-4-14C]-BCS-CN88460 in soybean plants , identification of unknown metabolites
Study date
10/05/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289476
Author
Bate, N.
Title
Input Xpro and Vimoy Iblon for stripe rust control in wheat
Study date
21/03/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287206
Author
Fischer, M.
Title
Specification - Plant protection product for Australia - isoflucypram EC 50 (50 g/L) - Vimoy Iblon; Vimoy Iblon 50 EC Fungicide
Study date
24/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287183
Author
Mosbey, J.
Title
Part 6 ? Occupational Health and Safety Vimoy Iblon 50 EC Fungicide
Study date
30/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285952
Author
EFSA
Title
Peer review of the pesticide risk assessment of the active substance isoflucypram
Study date
23/6/2022
Authorising party
Public
Auth party contact address
-
Data no
289247
Author
Traub, M.
Title
Metabolism of [phenyl-UL-14C]-BCS-CN88460 in soybean plants
Study date
27/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285995
Author
Persdorf, M.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on the activity of soil microflora (nitrogen transformation test)
Study date
15/10/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287169
Author
Anon.
Title
Assessment report - Evaluation of active substances - Isoflucypram - List of endpoints - Great Britain
Study date
31/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289491
Author
Poole, N., Murray, R., Warren, D. and Fuhrmann, K.
Title
Input Xpro and Vimoy Iblon rates for control of leaf rust in barley
Study date
16/02/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289253
Author
Tobias, S.
Title
Metabolism of [phenyl-UL-14C] BCS-CN88460 in wheat after seed treatment
Study date
06/04/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287192
Author
Ziske, J.; Andre, M.
Title
Determination of the dislodgeable foliar residues (DFR) of isoflucypram in/on spring wheat after spray application of BCS-CN88460 EC 50A G under protected conditions in Northern France and Poland
Study date
22/11/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289514
Author
Tiller, M.
Title
Vimoy Iblon+PTZ for control of septoria tritici blotch in wheat
Study date
28/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285956
Author
Schulz, L.
Title
Amendment no. 1 to the final report - BCS-CN88460 EC 50 G: Effects on the activity of soil microflora (Nitrogen transformation test)
Study date
13/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286027
Author
APVMA
Title
Project plan Item 27 timeshift
Study date
06/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285979
Author
Gladbach, A.; Blank, M.
Title
Summary of the fate and behaviour in the environment isoflucypram EC 50 (50 g/L) (Code: BCS-CN88460 EC 50)
Study date
01/02/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285964
Author
Waibel, J.
Title
Toxicity to the predatory mite Typhlodromus pyri (Acari: Phytoseiidae) using a laboratory test BCS-CN88460 EC 50 g/L
Study date
23/06/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285973
Author
Kuhl, K.
Title
Acute toxicity of BCS-CN88460 EC 50 G to the waterflea Daphnia magna in a static laboratory test system
Study date
10/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286010
Author
Richter, A.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Influence on mortality and reproduction of the collembolan species Folsomia candida tested in artificial soil
Study date
25/11/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309628
Author
M ller, R. U.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi (Hymenoptera: Braconidae) using an extended laboratory test on barley; isoflucypram + prothioconazole EC 200 (50 + 150 g/L)
Study date
12/09/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286019
Author
Anon.
Title
Assessment report - Evaluation of active substances - Isoflucypram - List of endpoints - Great Britain
Study date
31/03/2023
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287198
Author
Gueldner, W.; Hoppe, M.
Title
Storage stability at elevated temperature and cold stability of BCS-CN88460 EC 50 (50 g/L) - Packaging material: COEX/EVOH - Final report (14 days)
Study date
15/12/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286016
Author
Waibel, J.
Title
Toxicity to the green lacewing Chrysoperla carnea (Neuroptera: Chrysopidae) using an extended laboratory test on maize; isoflucypram + prothioconazole EC 200 (50+150 g/L)
Study date
07/02/2022
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289508
Author
Bate, N.
Title
Input Xpro and Vimoy Iblon rates for control of leaf rust in barley
Study date
04/03/2024
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289242
Author
Freitag, T.; Effertz, C.
Title
Determination of the residues of BCS-CN88460 in/on soil and the field rotational crops barley, carrot, turnip and lettuce after spray application of BCS-CN88460 EC 050 to bare soil in Germany, the Netherlands, southern France and Italy
Study date
20/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285970
Author
Schmitzer, S.
Title
Isoflucypram EC 50 G: Toxicity testing on honey bees (Apis mellifera L.) under semi-field conditions in Germany
Study date
14/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287201
Author
Schulz, F.; Garcia Sanchez, M. T.
Title
Validation of Analytical Method AM031618MF1 - Determination of BCS-CN45153 in the formulation isoflucypram EC 50 (50 g/L) - Final Report -
Study date
12/03/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287178
Author
Kov?cs, M.
Title
BCS-CN88460 EC 50 - In vitro skin irritation test in the EPISKIN (SM) model
Study date
30/05/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
306385
Author
Frensemeier, L.
Title
Validation of HPLC-method AM029617MP1 Isoflucypram (BCS-CN88460) Determination of impurities in technical grade active substance HPLC - external standard
Study date
6/12/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289222
Author
Heinemann, D.; Doebbe, A.
Title
Nature of the residues of [pyrazole-4-14C]BCS-CN88460 and [phenyl-UL-14C]BCS-CN88460 in processed commodities - High temperature hydrolysis
Study date
29/06/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287207
Author
Fischer, M.
Title
Specification - Plant protection product for Australia - isoflucypram EC 50 (50 g/L) - Vimoy Iblon; Vimoy Iblon 50 EC Fungicide
Study date
24/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287184
Author
M?ty?s, A.
Title
BCS-CN88460 EC 50 - Acute dermal toxicity study in the rat
Study date
24/05/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289236
Author
Bongartz, R.; Luks, A.-K.; Doebbe, A.; Conrad, F.
Title
[Phenyl-UL-14C]BCS-CN88460 - Metabolism in the lactating goat
Study date
18/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289485
Author
Laidlaw, R.
Title
Efficacy of Vimoy Iblon 50 EC for control of yellow leaf spot (Pyrenophora tritici-repentis) in wheat cv. Bale
Study date
28/03/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285990
Author
Larnaudie Lopez, M. I.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Influence on mortality and reproduction of the collembolan species Folsomia candida tested in artificial soil
Study date
04/09/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285996
Author
Obert-Rauser, P.
Title
Isoflucypram + prothioconazole EC 200 (50+150 gL): Toxicity to the single cell green alga Raphidocelis subcapitata korshikov under laboratory conditions
Study date
28/11/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287172
Author
Bernal, J.
Title
In-vitro human & rat skin penetration of 14C-BCS-CN88460 (isoflucypram) in ISY EC 50 test item
Study date
19/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289256
Author
Rogers, D.
Title
Determination of isoflucypram residues in barley and oats following applications of Vimoy Iblon (sp102000037709)
Study date
15/05/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287164
Author
Anon
Title
SDS all
Study date
30/04/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289494
Author
Warren, D., Bloomfield, M., Fuhrmann, K. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of net form net blotch in barley
Study date
07/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286007
Author
Bebon, R.; Schneider, C.
Title
Isoflucypram + prothioconazole EC200 - Toxicity to Pseudokirchneriella subcapitata in a 96-hour algal growth inhibition test
Study date
23/09/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289517
Author
Bogacki, P.
Title
Vimoy Iblon 50 EC Fungicide for the control of certain leaf diseases of wheat and barley: Part 8 ? Efficacy and Crop Safety
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285953
Author
Peters, B.; Rohland, A.
Title
Study on the effect of BCS-CN88460 EC 50 G (50 g/L) on honey bees (Apis mellifera L.) under semi-field conditions
Study date
02/03/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289225
Author
Lamshoeft, M.
Title
Metabolism of [phenyl-UL-14C]BCS-CN88460 in tomato
Study date
24/07/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
306382
Author
Mosbey, J.
Title
Vimoy Iblon 50 EC Fungicide Application 148382, Product number 96160 Chemistry s159 response
Study date
14/6/2026
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
309631
Author
B ttner, G.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Effects on survival, growth and reproduction of the earthworm Eisenia fetida tested in artificial soil
Study date
18/10/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285976
Author
Reinken, G.; Kallweit, W.
Title
Isoflucypram (ISY) and metabolite: PECsw,sed FOCUS EUR - Use in cereals in Europe
Study date
27/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
292067
Author
Warren, D., Bloomfield, M., Fuhrmann, K., Bosveld, D. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of leaf scald in barley
Study date
7/2/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286013
Author
Jans, D.
Title
Toxicity to the predatory mite Typhlodromus pyri (Acari: Phytoseiidae) using an extended laboratory test with aged residues on maize; isoflucypram + prothioconazole EC 200 (50+150 g/L)
Study date
07/12/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289505
Author
Murray, R., Vague, A., Fuhrmann, K. and Poole, N.
Title
Efficacy of Vimoy Iblon plus PTZ for the control of leaf scald in barley
Study date
07/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289511
Author
Anon
Title
Vimoy iblon draft label
Study date
July 2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287195
Author
Drafz, M.
Title
Safety-relevant data of BCS-CN88460 EC 50 (50 g/L)
Study date
25/08/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285967
Author
Jans, D.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi in an extended laboratory test with aged residues on maize soflucypram EC 50 g/L
Study date
13/09/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285993
Author
M?ller, R. U.
Title
Toxicity to the parasitoid wasp Aphidius rhopalosiphi (Hymenoptera: Braconidae) using an extended laboratory test on barley; isoflucypram + prothioconazole EC 200 (50 + 150 g/L)
Study date
12/09/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287204
Author
Fitzgerald, M.
Title
Manufacturing procedure - Plant protection product for Australia - isoflucypram EC 50 (50 g/L) - Vimoy Iblon 50 EC Fungicide
Study date
20/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289219
Author
Harbin, A. M.
Title
Determination of the residues of BCS-CN88460 in/on barley and the processed fractions (malt sprouts; brewer's malt; brewer's grain; hops draff; brewer's yeast; beer; pearl barley rub off and pearl barley) after spray application of BCS-CN88460 EC 050 in the field in the Netherlands and Spain
Study date
02/02/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289502
Author
Laffan, S.
Title
Vimoy Iblon + PTZ for control of ramularia leaf spot in barley
Study date
14/01/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289245
Author
Lagojda, A.; Kasel, D.
Title
Metabolism of [pyrazole-4-14C]-BCS-CN88460 in oilseed rape
Study date
07/11/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287181
Author
Mosbey, J.
Title
Part 3 - Summary of Toxicology on the active substance Isoflucypram
Study date
30/5/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285987
Author
Zetzmann, M.
Title
Isoflucypram + prothioconazole EC 200 (50+150 g/L): Toxicity to the water flea Daphnia magna straus under laboratory conditions (acute immobilisation test - semi-static)
Study date
02/08/2019
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
285999
Author
Waibel, J.
Title
Toxicity to the predatory mite Typhlodromus pyri (Acari: Phytoseiidae) using an extended laboratory test on maize; isoflucypram + prothioconazole EC 200 (50+150 g/L)
Study date
15/07/2021
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289233
Author
Bongartz, R.; Bartelsen, N.
Title
Amendment no 1: [Phenyl-UL-14C]BCS-CN88460 - Absorption, distribution, excretion and metabolism in the rat
Study date
26/10/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289239
Author
Uceda, L.
Title
Storage stability of residues of BCS-CN88460 and its metabolite BCS-CR60082 in tomato (fruit), bean (dry seed), wheat (grain), rape (seed) and orange (fruit) during deep freeze storage for at least 24 months
Study date
03/07/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289482
Author
Ryan, C.
Title
Vimoy Iblon + PTZ for control of stripe rust in wheat
Study date
03/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
289488
Author
Cocoma, D.
Title
Vimoy Iblon + PTZ for control of yellow leaf spot in wheat
Study date
27/02/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
287175
Author
EFSA
Title
Peer review of the pesticide risk assessment of the active substance isoflucypram
Study date
23/06/2022
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148607
Product/Active constituent Name

Application Product Name

NUFARM INTERCEPT HERBICIDE

Application details

Product name:

NUFARM INTERCEPT HERBICIDE

Product number:

69353

Applicant Name:

NUFARM AUSTRALIA LIMITED

Application purpose and description of use:

Variation of label approval to add imidazolinone herbicide tolerant chickpeas to the label of Nufarm Intercept.

Active constituents:

Active constituent name
51086 - IMAZAMOX
Active constituent name
67696 - IMAZAPYR

Description of data provided:

Data no
286990
Author
A. Ascough
Title
Determination of imazamox and imazapyr residues in imidazolinone herbicide tolerant chickpeas
Study date
April 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286984
Author
Z. Hall
Title
Imidazolinone Herbicide Tolerant Chickpea Field Studies - Crop Safety
Study date
March 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286987
Author
M. Van Drie
Title
Imidazolinone Herbicide Tolerant Chickpea Field Studies - Residue Crop Safety
Study date
March 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286981
Author
K. Lock
Title
OECD MRL calculator Intercept pulse group
Study date
May 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286988
Author
R. Farhoudi
Title
IMIDAZOLINONE HERBICIDE TOLERANT CHICKPEA CROP SAFETY FIELD STUDIES
Study date
April 2023
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286982
Author
M. Slatter
Title
Nufarm Intercept Crop Safety
Study date
May 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286976
Author
S. Pengelly
Title
DETERMINATION OF RESIDUES OF IMAZAMOX + IMAZAPYR IN IMIDAZOLINONE HERBICIDE TOLERANT CHICKPEA FOLLOWING A SINGLE APPLICATION OF INTERCEPTOR HERBICIDE
Study date
July 2023
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286985
Author
R. Shepherd
Title
IMIDAZOLINONE HERBICIDE TOLERANT CHICKPEA CROP SAFETY FIELD STUDIES
Study date
April 2023
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286979
Author
EFSA
Title
Reasoned opinion on the setting of MRLs for imazapyr in genetically modified soya bean and other oilseeds and in lentils
Study date
June 2014
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286977
Author
A. Ascough
Title
Determination of imazamox and imazapyr residues in imidazolinone herbicide tolerant chickpeas
Study date
April 2022
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286974
Author
C. Kelly and K. Lock
Title
Module 5.2A Residues
Study date
May 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286980
Author
K. Lock
Title
OECD MRL calculator Intercept Chickpeas
Study date
May 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286991
Author
S. Pengelly
Title
DETERMINATION OF RESIDUES OF IMAZAMOX + IMAZAPYR IN IMIDAZOLINONE HERBICIDE TOLERANT CHICKPEA FOLLOWING A SINGLE APPLICATION OF INTERCEPTOR HERBICIDE
Study date
July 2023
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286983
Author
Nufarm
Title
Marked up label
Study date
May 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286986
Author
R. Shepherd
Title
IMIDAZOLINONE HERBICIDE TOLERANT CHICKPEA CROP SAFETY FIELD STUDIES
Study date
April 2023
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286978
Author
EFSA
Title
Peer review of the pesticide risk assessment of the active substance imazamox
Study date
March 2016
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286989
Author
C. Ryan
Title
Crop Safety of Intercept Applied to IMI-Tolerant Chickpeas
Study date
March 2024
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
286975
Author
C. Kelly and K. Lock
Title
Module 5.2B Overseas Trade
Study date
May 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date

Application Date

Application No

Application Number

148154
Product/Active constituent Name

Application Product Name

eChem Pro-Met Gold Herbicide

Application details

Product name:

eChem Pro-Met Gold Herbicide

Product number:

96093

Applicant Name:

ECHEM (AUST) PTY LIMITED

Application purpose and description of use:

Registration of an 800 g/L prosulfocarb and 120 g/L s-metolachlor emulsifiable concentrate EC product for the Control of Annual Ryegrass (Lolium rigidum) and other grasses and broadleaf weeds in various crops

Reference details:

61234 - BOXER GOLD HERBICIDE

Active constituents:

Active constituent name
80726 - Prosulfocarb
Active constituent name
69340 - S-METOLACHLOR

Description of data provided:

Data no
285702
Author
Anon
Title
Reference label
Study date
11 April 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285696
Author
eChem Australia Pty Ltd
Title
Part 8 Efficacy and Crop Safety of eChem Pro-Met Gold Herbicide
Study date
April 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285693
Author
Anon
Title
Raw Material Specs
Study date
March 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285699
Author
eChem Australia Pty Ltd
Title
Scientific argument
Study date
11 April 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285694
Author
Yarnton A.
Title
Certificate of Analysis
Study date
28 February 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285697
Author
Anon
Title
Evaluation of eChem Pro-Met Gold Herbicide for the control of Silver grass (Vulpia bromoides, Vulpia myuros) in cereals
Study date
3 January 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285692
Author
Anon
Title
Part 2 The formulation of eChem Pro-Met Gold Herbicide
Study date
March 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285700
Author
Anon
Title
Part 8 Appendix 1 trial summaries
Study date
11 April 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285698
Author
Anon
Title
Evaluation of eChem Pro-Met Gold Herbicide for the control of Annual Ryegrass (Lolium rigidum) in lupins
Study date
16 January 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285701
Author
eChem Australia Pty Ltd
Title
Proposed Draft Label
Study date
11 April 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Data no
285695
Author
Yarnton A.
Title
Method Validation for the determination of Prosulfocarba and metolachlor
Study date
28 February 2025
Authorising party
Applicant
Auth party contact address
LEVEL 4, LANTOS PLACE 80 STAMFORD ROAD INDOOROOPILLY Australia
Date

Application Date

Application No

Application Number

148475
Product/Active constituent Name

Application Product Name

S-Metolachlor

Application details

Product name:

S-Metolachlor

Active name:

S-Metolachlor

Applicant Name:

NANTONG JIANGSHAN AGROCHEMICAL & CHEMICALS LTD LIAB CO

Application purpose and description of use:

Approval of S-Metolachlor for use in agricultural chemical products.
Date

Application Date

Application No

Application Number

148432
Product/Active constituent Name

Application Product Name

Quicksilver Herbicide

Application details

Product name:

Quicksilver Herbicide

Product number:

96172

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

Registration of a 240 g/L carfentrazone-ethyl emulsifiable concentrate (EC) product for the Control of Moss in Turf.

Reference details:

63103 - SILVERADO HERBICIDE

Active constituents:

Active constituent name
92581 - Carfentrazone-ethyl

Description of data provided:

Data no
286503
Author
Turf Culture P/L
Title
The development of a carfentrazone-ethyl 240 EC
Study date
May 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302301
Author
W Braybon
Title
To evaluate various products for Phytotoxicity in turf
Study date
21 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302295
Author
W Braybon
Title
To evaluate Post Emergent Herbicides for Moss Control in Turf
Study date
22 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286509
Author
Turf Culture P/L
Title
To evaluate 3 products for the control of moss in Bent grass (Agrostis stolonifera) Turf.
Study date
12 November 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286515
Author
Turf Culture P/L
Title
Rates vs Products vs Commerciality
Study date
30 April 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286523
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
Dose Responses of Silvery-thread Moss to Carfentrazone-ethyl
Study date
January 2015
Authorising party
Public
Auth party contact address
-
Data no
302304
Author
W Braybon
Title
To evaluate various products for Phytotoxicity in turf
Study date
21 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286506
Author
Anon
Title
Carfentrazone-ethyl - CoA
Study date
10 February 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286512
Author
Turf Culture Pty Ltd
Title
Evaluation of the Phytotoxic Potential of TC-009, TC-010, TC-011 and Coliseum on several warm and cool season turfgrass varieties.
Study date
16 March 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302298
Author
W Braybon
Title
To evaluate Post Emergent Herbicides for Moss Control in Turf
Study date
22 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302293
Author
W Braybon
Title
To evaluate Post Emergent Herbicides for Moss Control in Turf
Study date
29 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302299
Author
W Braybon
Title
Part 8(1) - Efficacy and Crop Safety
Study date
March 2026
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286507
Author
APVMA
Title
Notice of Approval of an Active Constituent
Study date
22 may 2023
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286504
Author
A Yarnton
Title
Method Validation for the determination of carfentrazone-ethyl in Formulation C
Study date
6 August 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286521
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
Dose responses of silvery-thread moss (Bryum argenteum) to carfentrazone-ethyl
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302302
Author
W Braybon
Title
To evaluate various products for Phytotoxicity in turf
Study date
21 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286510
Author
Turf Culture P/L
Title
To evaluate 3 products for the control of moss in Bent grass (Agrostis stolonifera) Turf.
Study date
12 March 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302296
Author
W Braybon
Title
To evaluate Post Emergent Herbicides for Moss Control in Turf
Study date
22 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286518
Author
Turf Culture P/L
Title
Turf Culture Smackdown NZ Moss & Broadleaf Herbicide - Label
Study date
16 November 2022
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302305
Author
W Braybon
Title
To evaluate various products for Phytotoxicity in turf
Study date
21 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302297
Author
W Braybon
Title
To evaluate Post Emergent Herbicides for Moss Control in Turf
Study date
22 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286522
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
How silvery-thread moss responds to carfentrazone-ethyl
Study date
October 2024
Authorising party
Public
Auth party contact address
-
Data no
286513
Author
Turf Culture Pty Ltd
Title
Evaluation of TC-009, TC-011 and TC-012 for the control of Moss in Bentgrass (Agrostis stolonifera) Turf
Study date
12 November 2011
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286519
Author
Zane Raudenbush , Steven J. Keeley , Cole Thompson and Mithila Jugulam4
Title
Dose responses of silvery-thread moss (Bryum argenteum) to carfentrazone-ethyl
Study date
8 June 2021
Authorising party
Public
Auth party contact address
-
Data no
302294
Author
W Braybon
Title
To evaluate Post Emergent Herbicides for Moss Control in Turf
Study date
29 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
302300
Author
W Braybon
Title
s159(1) Reply
Study date
March 2026
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286516
Author
FMC Corporation
Title
Quicksilver T&O Herbicide - USA label
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
302303
Author
W Braybon
Title
To evaluate various products for Phytotoxicity in turf
Study date
21 October 2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286505
Author
A Yarnton
Title
Testing Stability Report - Carfentrazone-ethyl EC (Formulation C)
Study date
6 August 2024
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286511
Author
Turf Culture P/L
Title
To evaluate 3 products for the control of moss in Bentgrass (Agrostis stolonifera) Turf.
Study date
16 December 2007
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286517
Author
FMC Corporation
Title
Best Management Practises - Silvery Threads Moss
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
286508
Author
Various
Title
Quicksilver - Excipient - SDSs
Study date
2025
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286514
Author
Turf Culture Pty Ltd
Title
Evaluation of the Phytotoxic Potential of TC-009, TC-010, TC-011 and Coliseum on several warm and cool season turfgrass varieties.
Study date
14 January 2008
Authorising party
Applicant
Auth party contact address
43 Gap Road Sunbury Australia
Data no
286520
Author
Zane Raudenbush, Ph.D.; Steven J. Keeley, Ph.D.; Cole Thompson, Ph.D.; Mithila Jugulam, Ph.D.
Title
How silvery-thread moss responds to carfentrazone-ethyl
Study date
21 April 2025
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

148010
Product/Active constituent Name

Application Product Name

Intersmooth 7200SI SPC Antifouling

Application details

Product name:

Intersmooth 7200SI SPC Antifouling

Product number:

96042

Applicant Name:

AKZO NOBEL PTY LIMITED

Application purpose and description of use:

Registration of a Copper present as CUPROUS OXIDE 620 - 685 g/L / COPPER PYRITHIONE 37 - 41 g/L / ZINEB 37 - 41 g/L Antifouling Paint for use to control marine growth below the waterline on vessels.

Reference details:

82066 - Interswift 6800HS Tin Free SPC Antifouling

Active constituents:

Active constituent name
58181 - COPPER PYRITHIONE
Active constituent name
51408 - ZINEB

Description of data provided:

Data no
285507
Author
Shaun Mizis
Title
Environmental Assessment ??? Leaching Behaviour
Study date
January 2025
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285504
Author
Akzo Nobel Pty Ltd BU M&PC Regulatory Affairs
Title
Intersmooth?? 7200Si SPC Antifouling Efficacy Report
Study date
April 2023
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285510
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute Oral Toxicity (Acute Toxic Class) Test in Rats
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285513
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute Eye Irritation Test in Rabbits
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285505
Author
Shaun Mizis
Title
Occupational Health and Safety Information (Product)
Study date
December 2024
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285511
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute DermalToxicity (Limit) Test in Rats
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285508
Author
Shaun Mizis
Title
Toxicity Data waiver in support of registration of Intersmooth 7200Si
Study date
January 2025
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285514
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Buehler test in guinea pigs for delayed skin sensitisation potential
Study date
21/03/2003
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285503
Author
Andrew Beaumont, Chris Wilson
Title
Intersmooth 7200Si Antifouling Paint: Physico-Chemical Properties, Including Accelerated Storage Stability
Study date
November 2022
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285509
Author
Lori Caret B.A.
Title
Interswift 655 Acute Inhalation Toxciity Study in Rats
Study date
30/12/2003
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285506
Author
Shaun Mizis
Title
Chemistry Manufacture and End Use (Product).
Study date
January 2025
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Data no
285512
Author
AMK Hutchinson DSc PhD
Title
Interswift 655 (BMA009) Acute Dermal Irritation Test in Rabbits
Study date
9/10/2002
Authorising party
Applicant
Auth party contact address
51 MCINTYRE ROAD SUNSHINE NORTH Australia
Date

Application Date

Application No

Application Number

148053
Product/Active constituent Name

Application Product Name

Firocoxib

Application details

Product name:

Firocoxib

Active name:

Firocoxib

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

New source of active constituent
Date

Application Date

Application No

Application Number

148372
Product/Active constituent Name

Application Product Name

Flupyradifurone

Application details

Product name:

Flupyradifurone

Active name:

Flupyradifurone

Applicant Name:

SHANGHAI E-TONG CHEMICAL CO LTD

Application purpose and description of use:

Approval of Flupyradifurone for use in agricultural chemical products.

Description of data provided:

Data no
308052
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Description of manufacturing process of Flupyradifurone and Impurity Information
Study date
2026
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
308053
Author
Shanghai E-Tong Chemical Co., Ltd
Title
COA of Flupyradifurone TC
Study date
2026
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
308054
Author
Shanghai E-Tong Chemical Co., Ltd
Title
S159 coverletter
Study date
2026
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
308051
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Information of Batch size
Study date
2026
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Date

Application Date

Application No

Application Number

148052
Product/Active constituent Name

Application Product Name

Dechra Firocoxib 57mg Tablets

Application details

Product name:

Dechra Firocoxib 57mg Tablets

Product number:

96063

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

Registration of a 57mg/tablet firocoxib tablet product for relief of pain and control of inflammation associated with osteoarthritis and other musculo-skeletal disorders. Also indicated for the control of post-operative pain associated with surgery; including soft tissue, orthopaedic and dental procedures.

Reference details:

58093 - PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL

Active constituents:

Active constituent name
96064 - Firocoxib

Description of data provided:

Data no
301706
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Process Validation Report
Study date
04 June 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285006
Author
L Tsirulnikov
Title
KFl-056-KC-3316
Study date
8 June 2017
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284992
Author
Anonymous
Title
Active Substance Master File - part 2
Study date
May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284995
Author
G Fallon, J Gleave
Title
ASTM001
Study date
19 May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285003
Author
G Fallon, L van Rensburg
Title
LS-AMYPLAIN Ed 06
Study date
27 Feb 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285009
Author
H Chambers
Title
DEC C 24035 W
Study date
31 January 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284998
Author
G Fallon, J Gleave
Title
ASTM009
Study date
20 October 2020
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285004
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Module 8.3 - Efficacy and Safety
Study date
February 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284990
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Module 2.3 - Chemistry and Manufacture
Study date
February 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285001
Author
U Lama, L van Rensburg
Title
ASTM211
Study date
5 September 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285007
Author
C Chark
Title
KFl-056-BC-4118
Study date
5 March 2019
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
301704
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Chromatograms
Study date
25 November 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284996
Author
G Fallon, J Gleave
Title
ASTM002
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285002
Author
U Lama, G Fallon, L Van Rensburg
Title
AMVP23_01
Study date
4 September 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
301707
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
s159 response
Study date
22 January 2026
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284993
Author
Anonymous
Title
Firocoxib Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284999
Author
G Fallon, J Gleave
Title
ASTM010
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285005
Author
P Phuwapattanachart, N Thengchaisri
Title
Analgesic efficacy of oral firocoxib in ovariohysterectomized cats
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
284991
Author
Anonymous
Title
Active Substance Master File - part 1
Study date
May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284994
Author
Dechra Veterinary Products (Australia) Pty Ltd (Ed)
Title
Excipient Monographs and Certificates of Analysis
Study date
December 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285000
Author
British Pharmacopoeial Comission
Title
Appendix XVI B. Microbiological Examination of Non-sterile Products
Study date
1 January 2025
Authorising party
Public
Auth party contact address
-
Data no
285008
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Pre-application assistance (PAA) - meeting record and advice
Study date
2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
301705
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Process Validation Protocol
Study date
24 March 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
284997
Author
G Fallon, J Gleave
Title
ASTM003
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Date

Application Date

Application No

Application Number

148055
Product/Active constituent Name

Application Product Name

Dechra Firocoxib 227mg Tablets

Application details

Product name:

Dechra Firocoxib 227mg Tablets

Product number:

96065

Applicant Name:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

Application purpose and description of use:

Registration of a 227mg/tablet firocoxib tablet product for relief of pain and control of inflammation associated with osteoarthritis and other musculo-skeletal disorders. Also indicated for the control of post-operative pain associated with surgery; including soft tissue, orthopaedic and dental procedures.

Reference details:

58093 - PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL
57941 - PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS

Active constituents:

Active constituent name
96068 - Firocoxib
Active constituent name
96064 - Firocoxib

Description of data provided:

Data no
285029
Author
F Roeber, H Chambers
Title
DEC C 24035 W
Study date
31 January 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285012
Author
Anonymous
Title
Active Substance Master File - part 2
Study date
May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285026
Author
L Tsirulnikov
Title
KFl-056-KC-3316
Study date
8 June 2017
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285023
Author
G Fallon, L von Rensburg
Title
Foil Specification
Study date
27 February 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285015
Author
G Fallon, J Gleave
Title
ASTM001
Study date
19 May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285027
Author
C Chark
Title
KFl-056-BC-4118
Study date
5 March 2019
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285018
Author
G Fallon, J Gleave
Title
ASTM009
Study date
20 October 2020
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285024
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Module 8.3 - Efficacy and Safety
Study date
March 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285010
Author
Dechra Veterinary Products (Australia) Pty Ltd
Title
Module 2.3 - Chemistry and Manufacture
Study date
March 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285030
Author
M Ahmad, AC Maxwell Walters
Title
Comparative dissolution study protocol
Study date
30 January 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285021
Author
U Lama, L von Rensburg
Title
ASTM211
Study date
5 September 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285025
Author
P Phuwapattanachart, N Thengchaisri
Title
Analgesic efficacy of oral firocoxib in ovariohysterectomized cats
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
285022
Author
U Lama, G Fallon, L von Rensburg
Title
AMVP23_01
Study date
4 September 2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285016
Author
G Fallon, J Gleave
Title
ASTM002
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285019
Author
G Fallon, J Gleave
Title
ASTM010
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285013
Author
Anonymous
Title
Firocoxib Certificates of Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285031
Author
G Ramanjaneyulu, L Van Resnberg
Title
Comparative dissolution study report
Study date
2 April 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285020
Author
British Pharmacopoeial Commission
Title
Appendix XVI B. Microbiological Examination of Non-sterile Products
Study date
1 January 2025
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285014
Author
DVP Australia Pty Ltd
Title
Excipient monographs and certificates of analysis
Study date
December 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285028
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Pre-application assistance (PAA) - meeting record and advice
Study date
21 February 2024
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285017
Author
G Fallon, J Gleave
Title
ASTM003
Study date
4 August 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Data no
285011
Author
Anonymous
Title
Active Substance Master File - part 1
Study date
May 2021
Authorising party
Applicant
Auth party contact address
2 Cal Close Somersby Australia
Date

Application Date

Application No

Application Number

148211
Product/Active constituent Name

Application Product Name

Alion 500 SC Herbicide

Application details

Product name:

Alion 500 SC Herbicide

Product number:

92296

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to add crop groups to the situations of use.

Active constituents:

Active constituent name
65379 - INDAZIFLAM

Description of data provided:

Data no
286102
Author
Pengelly, S.
Title
Indaziflam for long term weed control in orchards. M-825167-01-1
Study date
2022-10-12
Data no
286103
Author
Pengelly, S.
Title
Indaziflam for long term weed control in orchards. M-825188-01-1
Study date
2022-10-12
Data no
286108
Author
Loveless, R.
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 alone and in mixtures with glyphosate 540 g/L for weed control in stone fruit. M-876348-01-1
Study date
2009-10-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286094
Author
Desmarteau, D. A.; Fischer, D. R.
Title
AE 1170437 500 SC - Magnitude of the residue in/on pome fruit (CG 11). M-348053-01-1
Study date
2009-05-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286097
Author
Tulagi, I.
Title
Amended study report - 519 - Determination of residues of indaziflam and its metabolite in apples and grapes. M-596270-01-1
Study date
2016-05-06
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286105
Author
Davies, G.
Title
Efficacy of BCS-AA10717 (AE1170437) applied post-emergence in combination with knockdowns as a non-selective herbicide in peaches. M-826398-02-1
Study date
2025-04-04
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286114
Author
Stone, N.
Title
Indaziflam plus glyphosate for control of weeds in orchards. M-876463-01-1
Study date
2024-04-17
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286111
Author
Riethmuller, L.
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 50 WG alone and in mixtures with Roundup Power Max 540 SL and Hasten 704 SL adjuvant for knockdown and residual weed control in stone fruit. M-876351-01-1
Study date
2009-01-29
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286091
Author
Bruemmer, I.
Title
Determination of the residues of AE 1170437 in/on cherry after spraying of AE 1170437 (500 SC) in the field in Germany, Spain, Northern France and Italy - Amendment no. 1 to final report. M-308391-02-1
Study date
2023-03-02
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286100
Author
Davies, G.
Title
Module 8
Study date
2025-04-15
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286106
Author
Stone, N.
Title
Efficacy of BCS-AA10717 (AE1170437) applied post-emergence as a non-selective herbicide in peaches. M-876054-01-1
Study date
2009-08-06
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286112
Author
Stone, N.
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 50 WG alone and in mixtures with Roundup Power Max 540 SL and Hasten 704 SL adjuvant for knockdown and residual weed control in pome fruit. M-876443-01-1
Study date
2009-01-29
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286092
Author
Krolski, M. E.; Brungardt, J. N.; Stoughton, S. M.
Title
AE 1170437 500 SC - Magnitude of the residue in/on stone fruit (CG 12). M-347950-01-1
Study date
2009-05-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286109
Author
Loveless, R.
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 alone and in mixtures with glyphosate 540 g/L for weed control in stone fruit. M-876349-01-1
Study date
2009-11-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286089
Author
Fitzgerald, M.
Title
Module 5 Residues
Study date
2025-04-17
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286098
Author
Fletcher, G.
Title
Determination of residues of indaziflam and its metabolite in pear and stone fruit. M-876619-01-1
Study date
2017-05-22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286104
Author
Davies, G.
Title
Efficacy of BCS-AA10717 (AE1170437) applied pre-emergence as a non-selective herbicide in peaches. Amendment to final report. M-826270-02-1
Study date
2025-04-04
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286101
Author
Davies, G.
Title
Efficacy of Alion 500 SC, applied for pre-emergent weed control in stone fruit. Amendment to final report. M-825136-02-1
Study date
2025-04-15
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286107
Author
Loveless, R.
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 50 WG alone and in mixtures with Roundup Power Max 540 SL and Hasten 704 SL adjuvant for knockdown and residual weed control in stone fruit. M-876347-01-1
Study date
2009-10-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286095
Author
Lenz, C. A.
Title
AE 1170437 500 SC - Magnitude of the residue in/on apple processed commodities. M-348056-01-1
Study date
2009-05-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286113
Author
McMaster, I.
Title
Evaluation of nectarine crop safety from Indaziflam 500 SC application. M-876444-01-1
Study date
2024-04-17
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286110
Author
Stone, N.
Title
Evaluation of herbicide grass weed control in orchards. M-876350-01-1
Study date
2024-04-17
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286096
Author
Clay, S.
Title
Amended study report - 485 - Determination of residues of indaziflam and its metabolite in apples and grapes. M-596268-01-1
Study date
2016-05-06
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286090
Author
Braune, M.
Title
Determination of the residues of AE 1170437 in/on peach after spraying of AE 1170437 (500 SC) in the field in Germany, Spain and Italy - Amendment no. 1 to final report. M-308114-02-1
Study date
2023-03-01
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286099
Author
Clay, S.
Title
Determination of residues of indaziflam and metabolite in stonefruit and pears. M-876620-01-1
Study date
2018-06-01
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286093
Author
Stoughton, S. M.; Lenz, C. A.
Title
AE 1170437 500 SC - Magnitude of the residue in/on plum processed commodities. M-347951-01-1
Study date
2009-05-20
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date

Application Date

Application No

Application Number

148196
Product/Active constituent Name

Application Product Name

Gibberellin A4 with Gibberellin A7

Application details

Product name:

Gibberellin A4 with Gibberellin A7

Active name:

Gibberellin A4 with Gibberellin A7

Applicant Name:

ADAMA NEW ZEALAND LTD

Application purpose and description of use:

Approval of Gibberellin A4 and Gibberellin A7 for use in agricultural chemical products.

Description of data provided:

Data no
286054
Author
Anonymous
Title
Manufacture Process of GA4/7
Study date
14 April 2025
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286057
Author
Dalton J.
Title
Declaration of Composition for reference
Study date
17 October 2022
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286052
Author
ADAMA New Zealand Limited
Title
Chemistry and Manufacturing
Study date
14 April 2025
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286058
Author
Dalton J.
Title
Method Validation for the determination of gibberellin A4 and gibberellin A7 in a technical material (TC)
Study date
17 October 2022
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286055
Author
ADAMA New Zealand Limited
Title
Declaration of Composition signed
Study date
17 October 2022
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286056
Author
Dalton J.
Title
5 Batch Analysis Report (Active)
Study date
17 October 2022
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286053
Author
Dalton J.
Title
Impurity profile of gibberellin A4 + A7* technical material (TC) ACS-IPR-096
Study date
17 October 2022
Authorising party
Applicant
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Date

Application Date

Application No

Application Number

148197
Product/Active constituent Name

Application Product Name

Ulcesium 50 mg/mL Omeprazole Paste For Horses

Application details

Product name:

Ulcesium 50 mg/mL Omeprazole Paste For Horses

Product number:

96111

Applicant Name:

NAUTS EQUINE PTY LTD

Application purpose and description of use:

Registration of a 50 mg/mL omeprazole oral paste product for the treatment of gastric ulcers in horses and foals.

Reference details:

58757 - GASTROZOL DAILY ORAL PASTE FOR HORSES

Active constituents:

Active constituent name
83049 - Omeprazole 20%

Description of data provided:

Data no
285361
Author
Not specified
Title
Calculation table in full
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285367
Author
Not specified
Title
Manufacturing process flow chart
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285390
Author
EMEA
Title
Committee for Veterinary Medicinal Products ??? Omeprazole ??? Summary Report. EMEA/ MRL/841/02-FINAL.
Study date
2002
Authorising party
Public
Auth party contact address
-
Data no
285384
Author
S Colgan
Title
Bioequivalence of two omeprazole oral paste formulations in the horse. Study report 116NEEBeq.
Study date
2016
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285378
Author
Not specified
Title
Microbial testing results Ulcesium
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285347
Author
APVMA
Title
Ulcesium - PAA 141291 - Final advice
Study date
2023
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285364
Author
Not specified
Title
BPS for Ulcesium 241037 and 241038
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285387
Author
W Smith
Title
A study to determine the efficacy of a test formulation of omeprazole paste in the treatment and prevention of equine gastric ulcers when compared to a registered product in the horse. Study report 118NOC.
Study date
2018
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285370
Author
Not specified
Title
AM040 Ulcesium Finished Product Analytical Method Ed2
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285381
Author
Not specified
Title
Comparative stability study
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285358
Author
Not specified
Title
2025-04-16 - Ulcesium - Part 2 Chemistry Summary - FINAL
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285365
Author
Not specified
Title
VAR121 Process Validation Report Ed 2
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285382
Author
Not specified
Title
Ulcesium - Part 8 Efficacy and Safety Summary - FINAL
Study date
2020
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285373
Author
Not specified
Title
MVP035 Method Validation Protocol - Assay Ed.1
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285359
Author
Not specified
Title
Active Constituent CoA
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285353
Author
Not specified
Title
Response to notice 3
Study date
2023
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285385
Author
M Doherty
Title
Scientific justification for bioequivalence of Ulcerquine 50 mg/mL Omperazole Paste for Horses.
Study date
2016
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285362
Author
Not specified
Title
Excipient CoAs
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
301709
Author
Anon
Title
Excipient specifications
Study date
2026
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285379
Author
Not specified
Title
Appearance pics 241036
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285376
Author
Not specified
Title
MVR036 Method Validation Report Related Substances
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285393
Author
Ceva
Title
Omoguard Paste for Horses Safety Data Sheet.
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
285350
Author
Not specified
Title
Response to notice 1
Study date
2021
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285356
Author
APVMA
Title
Efficacy and safety report
Study date
2021
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285388
Author
W Smith
Title
A study to determine the efficacy of a test formulation of omeprazole paste in the treatment and prevention of equine gastric ulcers when compared to a registered product in the horse. Study report 218NOC.
Study date
2018
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285371
Author
Not specified
Title
App 2.13 - Validation of microbiological testing
Study date
2020
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285380
Author
Not specified
Title
Appearance pics 241037 and 241038
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285394
Author
Not specified
Title
Chemical analysis of reference product
Study date
2020
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285345
Author
APVMA
Title
Ulcerquine - PAA final response
Study date
2016
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285357
Author
APVMA
Title
Chemistry Report
Study date
2023
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285351
Author
APVMA
Title
APVMA Notice 1
Study date
2021
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285391
Author
Di Salvo et al
Title
Pharmacokinetics and tolerability of a new formulation of omeprazole in the horse.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
285368
Author
Not specified
Title
Packaging specifications
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285374
Author
Not specified
Title
MVR035 Method Validation report assay
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285377
Author
Not specified
Title
SR002 Ulcesium Stability report Ed 3
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285348
Author
Not specified
Title
2025-04-16 - Ulcesium - Regulatory Overview - FINAL
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285360
Author
Not specified
Title
Calculation table as per the BPS
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285354
Author
Not specified
Title
APVMA Notice 2
Study date
2023
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285386
Author
S Colgan
Title
A study to determine the bioequivalence of a test formulation of omeprazole paste versus a registered product in the horse. Study report 217NB.
Study date
2017
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285392
Author
Various
Title
Monographs for excipients
Study date
2009
Authorising party
Public
Auth party contact address
-
Data no
285363
Author
Not specified
Title
BPS018 Ulcesium PV B241036 executed
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285369
Author
Not specified
Title
Batch analysis CoAs
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
301708
Author
Anon
Title
Letter
Study date
2026
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285375
Author
Not specified
Title
MVP036 Method Validation Protocol RS Testing Ed.1
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285349
Author
Not specified
Title
Finished product specification
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285355
Author
APVMA
Title
2023-12-05 - Final PAA meeting record and written advice - 141291
Study date
2023
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285366
Author
Not specified
Title
VAP079 Validation protocol for Ulcesium 241036
Study date
2024
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285389
Author
Cowled et al
Title
Investigation of non-inferiority of a test formulation of omeprazole paste in the treatment and prevention of equine gastric ulcers, compared to a registered product, across two studies.
Study date
2020
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285372
Author
Not specified
Title
Method transfer of Ulcesium
Study date
2025
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285383
Author
Sykes et al
Title
ECEIM Consensus Statement - Equine Gastric Ulcer Syndrome in Adult Horses
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
285346
Author
APVMA
Title
Ulcerquine - item 25 final response
Study date
2017
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285352
Author
Not specified
Title
Response to notice 2
Study date
2022
Authorising party
Applicant
Auth party contact address
12A Morris Rd. Croydon Australia
Date

Application Date

Application No

Application Number

148289
Product/Active constituent Name

Application Product Name

Randlab Dex 5 mg/mL Injection

Application details

Product name:

Randlab Dex 5 mg/mL Injection

Product number:

89900

Applicant Name:

RANDLAB AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of the relevant particulars of product registration and label approval to add a new pack size and vary the sites of manufacture.

Active constituents:

Active constituent name
87297 - Dexamethasone Sodium Phosphate

Description of data provided:

Data no
291349
Author
Not identified
Title
Surface area calculation
Study date
21/08/2025
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291355
Author
EMA
Title
Eudralink
Study date
Unknown
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291361
Author
APVMA
Title
Notice of variation
Study date
10/02/2023
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
285564
Author
Anon
Title
Finished Product Specification
Study date
30/06/2020
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291358
Author
Randlab Australia Pty Ltd
Title
s159 Cover Letter and Response Discussion
Study date
2025
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291347
Author
Not identified
Title
Method Validation for active ingredient
Study date
May 2023
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291353
Author
Not identified
Title
Stability study report
Study date
25/10/2022
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291344
Author
EMA
Title
EMEA Sumary Report 1: Dexamethasone-summary report 1-committee-veterinary medicinal products (1996)
Study date
01/01/1996
Authorising party
Public
Auth party contact address
-
Data no
304958
Author
Not identified
Title
Stability study report
Study date
25/10/2022
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291350
Author
Not identified
Title
Method validation for the preservative
Study date
April 2023
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291356
Author
Toutain, P-L-et. al
Title
Dexamethasone and prednisolone in the horse: Pharmacokinetics and action on the adrenal gland.
Study date
Sept 1984
Authorising party
Public
Auth party contact address
-
Data no
304959
Author
Not identified
Title
Stability study report
Study date
25/10/2022
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291345
Author
EMA
Title
EMEA: Summary Report 2: Dexamethasone summary report 2-committe-veterinary medicinal products (1997)
Study date
March 1997
Authorising party
Public
Auth party contact address
-
Data no
291359
Author
APVMA
Title
Chemistry Report
Study date
25/01/2023
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291348
Author
Not identified
Title
Broached vial studies with Randlab Dex 5 Injection
Study date
02/11/2021
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291357
Author
Not identified
Title
Manufacturing Declaration Form
Study date
29/08/2025
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291360
Author
S D Mahashabde
Title
APVMA emails
Study date
18/06/2025
Authorising party
Applicant
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291346
Author
Plumb D C
Title
Dexamethasone: Wiley Publications, Veterinary Drug Handbook Seventh Edition
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
291354
Author
Soma L.R. et.al
Title
Pharmacokinetics of dexamethasone following intra-articular, intravenous, intramuscular and oral administration in horses and its effects on endogenous hydrocortisone
Study date
May 2012
Authorising party
Public
Auth party contact address
-