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
142263
Product/Active constituent Name
Application Product Name
Maropitant
Application Date
Application Number
142263
Application Product Name
Maropitant
Application details
Product name:
Maropitant
Active name:
Maropitant
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Approval of Maropitant for use in veterinary chemical products.
Description of data provided:
Data no
263525
Title
Appendix 1 Three CoAs of the Active
Study date
2021
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
280648
Title
S159 Response question 4-2 , Certificate of Analysis-2
Study date
Sep 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
280649
Title
S159 Response Question 4 Reply-3, Certificate of Analysis-3
Study date
Sep 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
280650
Title
S159 Notice Question 4 Reply-1 Certificate of Analysis-1
Study date
Sep 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
280651
Title
S159 Notice Question 2 Reply
Study date
Sep 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
263526
Title
Maropitant DMF
Study date
2022
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
280646
Title
S159 Notice Question 3 Reply
Study date
Sep 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Data no
280647
Title
S159 Notice Questions 3 and 5 Response
Study date
Sep 2024
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
142162
Product/Active constituent Name
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg
Application Date
Application Number
142162
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg
Application details
Product name:
Revolution Plus (selamectin/sarolaner) monthly topical solution for medium cats 2.6 – 5 kg
Product number:
87224
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
This application proposes to vary the REVOLUTION PLUS product range to add a label claim for a new parasite
Active constituents:
Active constituent name
56261 - SELAMECTIN
Active constituent name
80944 - SAROLANER
Active constituent name
86826 - SELAMECTIN
Date
Application Date
Application No
Application Number
142164
Product/Active constituent Name
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for small cats and kittens 1.25 – 2.5 kg
Application Date
Application Number
142164
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for small cats and kittens 1.25 – 2.5 kg
Application details
Product name:
Revolution Plus (selamectin/sarolaner) monthly topical solution for small cats and kittens 1.25 – 2.5 kg
Product number:
87225
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
This application proposes to vary the REVOLUTION PLUS product range to add a label claim for a new parasite.
Active constituents:
Active constituent name
56261 - SELAMECTIN
Active constituent name
80944 - SAROLANER
Active constituent name
86826 - SELAMECTIN
Date
Application Date
Application No
Application Number
142158
Product/Active constituent Name
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg
Application Date
Application Number
142158
Application Product Name
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg
Application details
Product name:
Revolution Plus (selamectin/sarolaner) monthly topical solution for large cats 5.1 – 10 kg
Product number:
87222
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
This application proposes to vary the REVOLUTION PLUS product range to add a label claim for a new parasite.
Active constituents:
Active constituent name
56261 - SELAMECTIN
Active constituent name
80944 - SAROLANER
Active constituent name
86826 - SELAMECTIN
Description of data provided:
Data no
262906
Title
Study 186C-ZA-21-270
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
262907
Title
Study A186C-US-14-130
Study date
2015
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
262908
Title
Preventative efficacy of Frontline Combo and Certifect against Dipylidium caninum infestation of cats and dogs using a natural flea (Ctenocephalides felis) infestation mode
Study date
2013
Auth party contact address
-
Data no
262909
Title
Preventative efficacy of Nexgard spectra against Dipylidium caninum infectionin dogs using a natural flea (Ctenocephalides feis) infestation model
Study date
2017
Auth party contact address
-
Data no
262910
Title
Analysis of Dipylidium caninum tapeworms from dogs and cats, or their respective fleas Part 2.
Study date
2018
Auth party contact address
-
Data no
262911
Title
Insecticide and acaricide molecules and/or combinations to prevent pet infestation by ectoparasites
Study date
2012
Auth party contact address
-
Data no
262912
Title
Prophylactic treatment of flea-infested cats with an imidacloprid/flumethrin collar to forestall infection with Dipylidium caninum
Study date
2012
Auth party contact address
-
Data no
262913
Title
Topical or oral fluralaner efficacy against flea (Ctenocephalides felis) transmission of Dipylidiu, caninum infection to dogs
Study date
2018
Auth party contact address
-
Data no
262914
Title
Analysis of Dipylidium caninum tapeworms from dogs and cats, or their respective fleas Part 1.
Study date
2018
Auth party contact address
-
Data no
262915
Title
Effects on the development of Dipylidium caninum and on the host reaction to this parasite in the adult flea (Ctenocephalides felis felis)
Study date
1987
Auth party contact address
-
Data no
262916
Title
Factors affecting the development of Dipylidium caninum in Ctenocephalides felis felis
Study date
1985
Auth party contact address
-
Data no
262917
Title
Dipylidium caninum in the twenty-first century: epidemiological studies and reported cases in companion animals and humans
Study date
2022
Auth party contact address
-
Data no
262918
Title
The biology, ecology and management of the cat flea
Study date
1997
Auth party contact address
-
Data no
276145
Title
p8-a3-A186C-ZA-21-270-flea-infection-counts
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276150
Title
p8-a4-A186C-US-23-294-study
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276147
Title
p8-beugnet-et-al-2022
Study date
2022
Auth party contact address
-
Data no
276148
Title
p8-geurden-et-al-2022
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276149
Title
p8-vich-gl7-2000
Study date
2000
Auth party contact address
-
Data no
262902
Title
PArt 1 Application Overview
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
262905
Title
Part 8 Overview
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
278248
Title
Response to s159 notice p13-rev-plus-flea-tape-s159-rtq-jul24
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
262903
Title
Rev Plus Label RLP
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
262904
Title
RevPlus Dosage Table
Study date
2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
276146
Title
p8-apvma-2020
Study date
2020
Auth party contact address
-
Date
Application Date
Application No
Application Number
142430
Product/Active constituent Name
Application Product Name
TITAN SIMAZINE 500 Flowable Herbicide
Application Date
Application Number
142430
Application Product Name
TITAN SIMAZINE 500 Flowable Herbicide
Application details
Product name:
TITAN SIMAZINE 500 Flowable Herbicide
Product number:
92665
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternate formulation to registration details
Active constituents:
Active constituent name
57791 - SIMAZINE
Description of data provided:
Data no
264329
Title
Certificate of analysis
Study date
December 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264321
Title
Chemistry & Manufacture Titan Simazine 500 SC
Study date
November 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264323
Title
SAFETY DATA SHEET
Study date
September 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264324
Title
SAFETY DATA SHEET
Study date
April 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264325
Title
SAFETY DATA SHEET
Study date
April 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264326
Title
SAFETY DATA SHEET
Study date
June 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264327
Title
SAFETY DATA SHEET
Study date
September 2018
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264328
Title
SAFETY DATA SHEET
Study date
November 2022
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264322
Title
Storage Stability of Titan Simazine 500 SC
Study date
November 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272305
Title
Section 159(1) (a) - Notice of requirement of information
Study date
May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272304
Title
Notice of recategorization of application
Study date
May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
142189
Product/Active constituent Name
Application Product Name
Screen 2P Wear (Non-Perfumed)
Application Date
Application Number
142189
Application Product Name
Screen 2P Wear (Non-Perfumed)
Application details
Product name:
Screen 2P Wear (Non-Perfumed)
Product number:
94355
Applicant Name:
CALLINGTON HAVEN PTY LTD
Application purpose and description of use:
Registration of Screen2P Wear (Non-Perfumed) containing Permethrin 4%w/w clothes become a barrier against mosquito bites (Aedes, Culex, Anopheles), which can carry vector-borne diseases.
Reference details:
89427 - Chemblend Permethrin 500 Timber and Pest Termiticide and Insecticide
Active constituents:
Active constituent name
89258 - Permethrin
Description of data provided:
Data no
263523
Title
Screen2P Wear ( Non-perfumed) SDS 20231130
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263524
Title
Screen2P Wear (Non-Perfumed) 100ml Label
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263522
Title
PAA2-137814 Meeting and written advice
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270590
Title
Emulgin CO 40 SDS
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270591
Title
Iso Propanol AUS-SDS
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270592
Title
MSDS Castor Oil (30-40 EO)
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270593
Title
Phenoxyethanol P10 AUS GHS
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270594
Title
SDS-PERMETHRIN 93% (Permethrin 93% Tech (25{3}75)) (ID 4967)
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270595
Title
Updated DBA SDS EN 2022
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270596
Title
XANTHAN GUM (23.12.2022)
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Date
Application Date
Application No
Application Number
142213
Product/Active constituent Name
Application Product Name
Screen 2P Wear
Application Date
Application Number
142213
Application Product Name
Screen 2P Wear
Application details
Product name:
Screen 2P Wear
Product number:
94357
Applicant Name:
CALLINGTON HAVEN PTY LTD
Application purpose and description of use:
Registration of Screen2P Wear(Perfumed) containing 4% w/w Permethrin for clothes become a barrier against mosquito
bites (Aedes, Culex, Anopheles), which can carry vector-borne diseases,
Reference details:
89427 - Chemblend Permethrin 500 Timber and Pest Termiticide and Insecticide
Active constituents:
Active constituent name
89258 - Permethrin
Description of data provided:
Data no
263399
Title
Certificate of Analysis, Permethrin
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263400
Title
Screen2P Wear Method of Analysis
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263401
Title
Screen2P Wear Stability Data
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263403
Title
Screen2P Wear Insecticide Efficacy Resultat
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263404
Title
Screen2P Wear Culex Anapheles Insecticide Efficacy
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263405
Title
Screen2P Wear SDS 20211011
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263397
Title
PAA2-137814 Meeting and written advice
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
263406
Title
Screen2P Wear label 200ml
Study date
2023
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270597
Title
Emulgin CO 40 SDS
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270598
Title
Geraniol SDS 2023 EN
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270599
Title
Iso_Propanol-AUS_SDS
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270600
Title
MSDS Castor Oil (30-40 EO)
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270601
Title
Phenoxyethanol P10 AUS GHS
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270602
Title
SDS-PERMETHRIN 93% (Permethrin 93% Tech (25{3}75)) (ID 4967)
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270603
Title
Updated DBA SDS EN 2022
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
270604
Title
XANTHAN GUM (23.12.2022)
Study date
18/04/2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Date
Application Date
Application No
Application Number
142250
Product/Active constituent Name
Application Product Name
Glufosinate-P-Ammonium manufacturing concentrate
Application Date
Application Number
142250
Application Product Name
Glufosinate-P-Ammonium manufacturing concentrate
Application details
Product name:
Glufosinate-P-Ammonium manufacturing concentrate
Active name:
Glufosinate-P-Ammonium manufacturing concentrate
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Approval of Glufosinate-P-Ammonium manufacturing concentrate for use in agricultural chemical products.
Description of data provided:
Data no
273542
Title
Validation of an analytical method for determination of cyanide in Glufosinate-ammonium BAS 1000 H (TC 95) and BAS 1000 02 H (TK 50) by means of ion chromatography. BASF DocID: 2021/2004270
Study date
05/07/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273543
Title
Validation of an analytical method for the determination of organic solvents in Glufosinate-ammonium BAS 1000 H (TC 95) and BAS 1000 02 H (TK 50) by headspace GC. BASF DocID: 2021/2004283
Study date
19/07/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273544
Title
Validation of an analytical method for determination of ammonium and sodium in Glufosinate-ammonium BAS 1000 H (TC 95) and BAS 1000 02 H (TK 50) by means of ion chromatography BASF DocID: 2021/2004287
Study date
23/09/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273545
Title
Validation of an analytical method for determination of chloride and acetate in Glufosinate-ammonium BAS 1000 H (TC 95) and BAS 1000 02 H (TK 50) by means of ion chromatography BASF DocID: 2021/2004290
Study date
28/09/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273546
Title
Validation of an analytical method for the determination of the active ingredient Reg. No. 163209 in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by HPLC. BASF DocID: 2021/2016412
Study date
17/12/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273547
Title
Validation of an analytical method for the determination of the enantiomers Glufosinate-P (Reg. No. 6113987) and Glufosinate-M (Reg. No. 6113988) in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by HPLC. 2021/2016420
Study date
15/02/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273548
Title
Additional validation of an analytical method for the determination of the organic solvent methanol in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by headspace GC. BASF DocID: 2021/2016425
Study date
09/02/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273549
Title
Additional Validation of an analytical method for determination of ammonium in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) by means of ion chromatography. 2021/2016567
Study date
30/05/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273550
Title
Additional validation of an analytical method for determination of chloride in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) by means of ion chromatography. 2021/2016569
Study date
12/04/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273551
Title
Additional validation of an analytical method for determination of cyanide in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) by means of ion chromatography 2021/2016571
Study date
29/03/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273552
Title
Validation of an analytical method for the determination of the impurities PPA (Reg. No. 6114949) and PPO (Reg. No. 6114951) in L-Glufosinate-ammonium BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by HPLC-MS. 2021/2017098
Study date
05/04/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273553
Title
Additional Validation of an analytical method for determination of ammonium in L-Glufosinate-ammonium (L-GA) BAS 1010 03 H (TK 50) by means of ion chromatography. 2021/2027504
Study date
26/04/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273554
Title
Additional validation of an analytical method for determination of chloride in L-Glufosinate-ammonium (L-GA) BAS 1010 03 H (TK 50) by means of ion chromatography. 2021/2027505
Study date
14/04/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273555
Title
Additional validation of an analytical method for determination of cyanide in L-Glufosinate-ammonium (L-GA) BAS 1010 03 H (TK 50) by means of ion chromatography. 2021/2027506
Study date
30/03/2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273556
Title
Validation of the Analytical Method AFL1066/01"Determination of sodium in L-Glufosinate-ammonium BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by means of ion chromatography". 2022/2011970
Study date
17/03/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
273557
Title
Add. Valid. of the Analytical Method AFL1027/04 "Determination of organic solvents in Glufosinate-ammonium (GA) BAS 1000 H (TC 95) + BAS 1000 02 H (TK 50) and L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) + BAS 1010 03 H (TK50) by HS GC. 2022/2060702
Study date
27/03/2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278347
Title
LWGA02H2; Validation report LC determination of glufosinate-ammonium (reg. no.: 163209) in glufosinate-ammonium (BAS 1000 02 H). BASF DocID 2022/2053085
Study date
06/07/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278348
Title
IAGA02H1; Validation of the test specification for the determination of anions in Basta TK (BAS 1000 02 H)
using IC. BASF DocID 2022/2053094
using IC. BASF DocID 2022/2053094
Study date
09/09/2020
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278349
Title
IKGA02H2; Validation report IC determination of cations in Basta TK 50 (BAS 1000 02 H). BASF DocID 2022/2053096
Study date
22/02/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278350
Title
LNGA02H1; Validation report LCMS determination of PPA (reg. no 6114949), hydroxybutyric acid (reg. no. 6142594) in glufosinate ammonium (TGAI, BAS 1000 H) and PPA (reg. no 6114949), PPO (reg. no. 6114951)
in L-glufosinate ammonium (TGAI, BAS 1010 H). BASF DocID 2022/2053101
in L-glufosinate ammonium (TGAI, BAS 1010 H). BASF DocID 2022/2053101
Study date
23/05/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278351
Title
GLGA02H1; Validation of the test specification for the determination of methanol (reg. no. 211342) and 1-butanol (reg. no. 4080622) in Basta TK (BAS 1000 02 H) using gas chromatography. BASF DocID 2022/2053104
Study date
29/10/2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278352
Title
Photometic Determination of Cyanide/ Prussic Acid. Method LM/04651/02e
Study date
08/08/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278353
Title
Validation report Photometic Determination of Cyanide/ Prussic Acid. Method: LM_04651_02e
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278354
Title
Analytical Method APL0802/01. Determination of the enantiomers Glufosinate-P (Reg. No. 6113987) and Glufosinate-M (Reg. No. 6113988) in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by HPLC. 2021/2016421
Study date
15/02/2022
Data no
278355
Title
Validation of an analytical method for the determination of the enantiomers Glufosinate-P (Reg. No. 6113987) and Glufosinate-M (Reg. No. 6113988) in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) and BAS 1010 03 H (TK 50) by HPLC. 2021/2016420
Study date
15/02/2022
Data no
272950
Title
Analytical Method APL0802 /01; Determination of the enantiomers Glufosinate-P (Reg. No. 6113987 ) and Glufosinate-M (Reg. No. 6113988 ) in L-Glufosinate-ammonium (L-GA ) BAS 1010 H (TC 88 ) and BAS 1010 03 H (TK 50 ) by HPLC
2021/2016421
2021/2016421
Study date
15/02/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272951
Title
Additional validation of an analytical method for determination of cyanide in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) by means of ion chromatography 2021/2016571
Study date
29/03/2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272952
Title
Analytical Method APL0795/02 Determination of cyanide in Glufosinate-ammonium (GA) BAS 1000 H (TC 95) + BAS 1000 02 H (TK 50) and in L-Glufosinate-ammonium (L-GA) BAS 1010 H (TC 88) + BAS 1010 03 H (TK 50) by means of Ion Chromatography. 2021/2016572
Study date
26/04/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272953
Title
Analytical method LWGA02H2, LC determination of Glufosinate ammonium (Reg.No.: 163209) in Glufosinate-ammonium (BAS 1000 02 H).2022/2053084
Study date
07/07/2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272954
Title
Analytical method IAGA02H1, IC determination of Acetate and Chloride Ions in Basta TK (BAS 1000 02 H). 2022/2053092
Study date
09/09/2020
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272955
Title
Analytical method IKGA02H2, Test method, IC determination of Cations in Basta TK 50 (BAS 1000 02 H). 2022/2053095
Study date
22/02/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272956
Title
Analytical method LNGA02H1, LCMS determination of PPA (Reg.No. 6114949), Hydroxybutanoic acid (Reg.No. 6142594) in Glufosinate Ammonium (TGAI, BAS 1000 H) and PPA (Reg.No. 6114949), PPO (Reg.No. 6114951) in LGlufosinate Ammonium (TGAI, BAS 1010 H) 2022/2053100
Study date
24/05/2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272957
Title
Analytical method GLGA02H1, GC Headspace determination of Methanol (Reg.No.: 211342) und 1-Butanol (Reg.No. 4080622) in Basta TK (BAS 1000 02 H) 2022/2053102
Study date
29/10/2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272959
Title
LWGA02H2 - Test method - LC determination of Glufosinate-ammonium (Reg.No.: 163209) in Glufosinate-ammonium (BAS 1000 02 H)
Study date
2021-07-06
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272960
Title
IAGA02H1 - Test method - IC determination of Acetate and Chloride Ions in Basta TK (BAS 1000 02 H)
Study date
2020-09-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272962
Title
LNGA02H1 - Test method - LCMS determination of PPA (Reg.No. 6114949), Hydroxybutanoic acid (Reg.No. 6142594) in Glufosinate Ammonium (TGAI, BAS 1000 H) and PPA (Reg.No. 6114949), PPO (Reg.No.6114951) in L-Glufosinate Ammonium (TGAI, BAS 1010 H)
Study date
2022-05-23
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272958
Title
Composition Analysis of Multiple Batches of L-Glufosinate-ammon Manufacturing-use Product (MUP) (BAS 1010 03 H),
Study date
2022-06-03
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272963
Title
GLGA02H1 - GC Headspace determination of Methanol (Reg.No.:211342) und 1-Butanol (Reg.No.4080622) in Basta TK (BAS 1000 02 H)
Study date
2019-10-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
272961
Title
IKGA02H2 - Test method - IC determination of Cations in Basta TK 50 (BAS 1000 02 H)
Study date
2022-02-22
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
263520
Title
Declaration of Composition
Study date
04/12/2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
263519
Title
APVMA Advice
Study date
22/05/2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
142148
Product/Active constituent Name
Application Product Name
ropinirole hydrochloride
Application Date
Application Number
142148
Application Product Name
ropinirole hydrochloride
Application details
Product name:
ropinirole hydrochloride
Product number:
94342
Applicant Name:
MAVLAB ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 30 mg/mL eye drops solution product for induction of vomiting in dogs, in conjunction with approval of ropinirole hydrochloride.
Description of data provided:
Data no
262583
Title
3-2-s-4-2-analytical-procedures
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262587
Title
app-1-validation-report-residual-solvents
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262585
Title
app-1-residual-solvents
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262814
Title
Active constituent CoAs
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262584
Title
manufacturer-1
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262581
Title
3-2-s-1-general-information
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262582
Title
3-2-s-3-characterisation
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262815
Title
CEP ropinirole-hydrochloride
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262816
Title
Drig Master File: ropinirole
Study date
2023
Auth party contact address
Veerabhadraswamy temple road, Gummadidala Mandal, Sangareddy District, India-502 313 Bonthapally Village, Telangana
Data no
262586
Title
3-2-s-4-3-validation-of-analytical-procedures
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Date
Application Date
Application No
Application Number
142149
Product/Active constituent Name
Application Product Name
Clevor 30 mg/mL Eye Drops Solution
Application Date
Application Number
142149
Application Product Name
Clevor 30 mg/mL Eye Drops Solution
Application details
Product name:
Clevor 30 mg/mL Eye Drops Solution
Product number:
94343
Applicant Name:
MAVLAB ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 30 mg/mL eye drops solution product for induction of vomiting in dogs, in conjunction with approval of ropinirole hydrochloride.
Active constituents:
Active constituent name
94342 - ropinirole hydrochloride
Description of data provided:
Data no
262737
Title
32s44-batch-analyses
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262735
Title
32s21-manufacturer
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262736
Title
32s41-specification
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262738
Title
32p6-reference-standards
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262739
Title
app-1-coa-working-standard-uspep
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262781
Title
32p52-analytical-proc
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262782
Title
app-1-M122716-clarity-of-solution
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262783
Title
app-2-M122717-colour-of-solution
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262784
Title
app-3-M122721-particulates-particles
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262785
Title
app-4-M122723-appearance
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262786
Title
app-5-M122718-identif-assay-rel-subst
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262787
Title
app-6-M122722-uniformity-dosage-mass-var
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262788
Title
app-7-M122720-pH
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262789
Title
app-8-M113205-sterility
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262790
Title
32p53-validation-analytical-procedures
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262791
Title
app-1-validation-report-id-assay-rel-subst
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262792
Title
app-2-validation-report-sterility
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262793
Title
32p54-batch-analyses
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262794
Title
32p55-characterisation-impurities
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262795
Title
32p56-justification-of-specifications
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262796
Title
32p7-container-closure-system
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262797
Title
app-1-conformity-cert-ampoule
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262798
Title
app-2-compliance-cert-pouch
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262799
Title
app-3-drawing-ampoule
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262800
Title
app-4-coa-ampoule
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262801
Title
app-5-coa-pouch
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262779
Title
32p31-manufacturers
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262780
Title
32p51-specifications
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262740
Title
32p1-description-and-composition
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262741
Title
32p21-components-drug-prod
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262742
Title
32p46-novel-excipients
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262743
Title
32p22-drug-prod
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262745
Title
32p23-manuf-proc-devt
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262746
Title
app-1-hold-time-study
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262747
Title
32p24-container-closure-system
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262750
Title
32p32-batch-formula
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262751
Title
32p33-desc-mfg-proc-and-proc-contr
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262752
Title
app-1-material-flow
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262753
Title
app-2-people-flow
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262754
Title
app-3-clean-area-classif
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262755
Title
app-4-s-l-hall-1-material-flow
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262756
Title
app-5-s-l-hall-1-people-flow
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262757
Title
app-6-s-l-hall-3-pouching
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262761
Title
32p34-control-critical-steps
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262762
Title
32p35-process-validation-evaluation
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262763
Title
app-1-media-fill-3012-139
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262764
Title
app-2-media-fill-3012-108
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262765
Title
app-3-media-fill-3012-201
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262766
Title
app-4-media-fill-3012-097
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262767
Title
app-5-bacterial-retention-validation
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262768
Title
32p41-specifications
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262769
Title
32p42-analytical-procedures
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262770
Title
32p43-validation-analytical-proc
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262771
Title
32p44-justification-of-spec-2
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262772
Title
app-1-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262773
Title
app-3-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262774
Title
app-4-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262775
Title
app-5-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262776
Title
app-6-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262777
Title
app-2-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262569
Title
App 26.1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262576
Title
Appendix 1.3
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262580
Title
5-8-flow-chart-of-manufacturing-sites
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262570
Title
App 28.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262571
Title
App 19.1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262778
Title
32p45-excipients-human-animal
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262758
Title
33-literature-references
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262759
Title
Tear film osmolarity in healthy dogs
Study date
2009
Auth party contact address
-
Data no
262760
Title
Development and Validation of Ropinirole Hydrochloride and its Related Compounds by UPLC in API and Pharmaceutical Dosage Forms
Study date
2010
Auth party contact address
-
Data no
262748
Title
32p25-microbiol-attributes
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262749
Title
32p26-compatibility
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262744
Title
app-1-supportive-stability
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262802
Title
32p81-stability-summary-conclusion
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262803
Title
32p82-post-approval-stability
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262804
Title
32p83-stability-data
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262805
Title
app-1-results-primary-and-scale-up-stability
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262806
Title
app-2-results-in-use-stability
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262807
Title
app-3-results-freeze-thaw
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262808
Title
app-4-results-photostability
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262809
Title
app-5-results-in-use-stability-end
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262810
Title
app-6-results-stability-commercial-batches
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262719
Title
Effectiveness and adverse effects of the use of apomorphine and 3% hydrogen peroxide solution to induce emesis in dogs
Study date
2012
Auth party contact address
-
Data no
262720
Title
Opioid analgesic drugs
Study date
2009
Auth party contact address
-
Data no
262725
Title
Small Animal Toxicology - Toxicologic Decontamination
Study date
2013
Auth party contact address
-
Data no
262726
Title
Use of Body Surface Area (BSA)-Based Dosages to Calculate Chemotherapeutic Drug Dose in Dogs: I. Potential Problems with Current BSA Formulae
Study date
1998
Auth party contact address
-
Data no
262671
Title
Clinical
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262674
Title
13000038
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262731
Title
SPC Emedog
Study date
2015
Auth party contact address
-
Data no
262577
Title
Appendix 10.1
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262568
Title
Solid phase gastric emptying times in the dog measured by 13C-sodium-acetate breath test and 99mTechnetium radioscintigraphy
Study date
2010
Auth party contact address
-
Data no
262579
Title
Use of Body Surface Area (BSA)-Based Dosages to Calculate Chemotherapeutic Drug Dose in Dogs: I. Potential Problems with Current BSA Formulae
Study date
1998
Auth party contact address
-
Data no
262557
Title
Appendix 58.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262558
Title
Appendix 58.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262559
Title
Appendix 58.3
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262560
Title
Appendix 59.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262561
Title
Appendix 63.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262564
Title
Comparison of the Effects of Central and Peripheral Dopamine Receptor Activation on Evoked Firing in the Trigeminocervical Complex
Study date
2009
Auth party contact address
-
Data no
262565
Title
Top 5 ingestions that require induction of emesis
Study date
2015
Auth party contact address
-
Data no
262550
Title
Appendix 7.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262603
Title
13000038
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262679
Title
V3111001 Veterinary clinical study report
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262680
Title
V3111001 Appendix 1
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262681
Title
V3111001 Appendix 2
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262682
Title
V3111001 Appendix 4
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262683
Title
V3111001 Appendix 6
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262684
Title
V3111001 Appendix 7
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262685
Title
V3111001 Appendix 8
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262686
Title
V3111001 Appendix 9
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262687
Title
V3111001 Appendix 10
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262688
Title
V3111001 Appendix 12
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262689
Title
V3111002 Veterinary clinical study report
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262690
Title
V3111002 Appendix 1
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262691
Title
V3111002 Appendix 2
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262692
Title
V3111002 Appendix 3
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262693
Title
V3111002 Appendix 4
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262694
Title
V3111002 Appendix 6
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262695
Title
V3111002 Appendix 7
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262696
Title
V3111002 Appendix 8
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262697
Title
V3111002 Appendix 9
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262698
Title
V3111002 Appendix 10
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262699
Title
V3111002 Appendix 12
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262700
Title
V3111003 Veterinary clinical study report
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262701
Title
V3111003 Appendix 1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262702
Title
V3111003 Appendix 2
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262703
Title
V3111003 Appendix 3
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262704
Title
V3111003 Appendix 4
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262705
Title
V3111003 Appendix 5
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262706
Title
V3111003 Appendix 6
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262707
Title
V3111003 Appendix 7
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262708
Title
V3111003 Appendix 8
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262709
Title
V3111003 Appendix 9
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262710
Title
V3111003 Appendix 10
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262711
Title
V3111003 Appendix 12
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262566
Title
Differential Actions of Antiparkinson Agents at Multiple Classes of Monoaminergic Receptor. I. A Multivariate Analysis of the Binding Profiles of 14 Drugs at 21 Native and Cloned Human Receptor Subtypes
Study date
2002
Auth party contact address
-
Data no
262567
Title
Parkinson's disease and anaesthesia
Study date
2002
Auth party contact address
-
Data no
262578
Title
Appendix 15.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262669
Title
Development of resistance
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262677
Title
R150339
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262678
Title
R160040
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262713
Title
In vitro identification of the P450 enzymes responsible for the metabolism of ropinirole
Study date
1997
Auth party contact address
-
Data no
262715
Title
Emesis in dogs: a review
Study date
2010
Auth party contact address
-
Data no
262812
Title
R160282
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262813
Title
R170055
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262673
Title
508038
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262717
Title
Dopamine receptor agonists differ in their actions on cardiac ion channels
Study date
2003
Auth party contact address
-
Data no
262714
Title
Comparison of the functional potencies of ropinirole and other dopamine receptor agonists at human D2(long), D3 and D4.4 receptors expressed in Chinese hamster ovary cells
Study date
1999
Auth party contact address
-
Data no
262668
Title
Pharmacology
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262727
Title
Disposition of ropinirole in animals and man
Study date
1999
Auth party contact address
-
Data no
262728
Title
Comparative Pharmacological Study of Ropinirole (SKF-101468) and its Metabolites in Rats
Study date
2000
Auth party contact address
-
Data no
262729
Title
Treatment of Disorders of Bowel Motility and Water Flux; Anti-Emetics; Agents Used in Biliary and Pancreatic Disease
Study date
2011
Auth party contact address
-
Data no
262730
Title
Effects of ropinirole on action potential characteristics and the underlying ion currents in canine ventricular myocytes
Study date
2010
Auth party contact address
-
Data no
262721
Title
Receptor-Binding and Pharmacokinetic Properties of Dopaminergic Agoanists
Study date
2009
Auth party contact address
-
Data no
262722
Title
Decontaminating the Poisoned Patient
Study date
2013
Auth party contact address
-
Data no
262723
Title
Functional group metabolism of dopamine-2 agonists: conversion of 4-(2-di-n-propylaminoethyl)-2-(3H)-indolone to 4-(2-di-n-propylaminoethyl)-7-hydroxy-2-(3H)-indolone
Study date
1986
Auth party contact address
-
Data no
262724
Title
Functional potencies of new antiparkinsonian drugs at recombinant human dopamine D1 , D2 and D3 receptors
Study date
1999
Auth party contact address
-
Data no
262732
Title
SPC Requip
Study date
2016
Auth party contact address
-
Data no
262733
Title
Pharmacokinetics of Dopamine-2 Agonists in Rats and Dogs
Study date
1986
Auth party contact address
-
Data no
262734
Title
Assessment of Potential Interactions Between Dopamine Receptor Agonists and Various Human Cytochrome P450 Enzymes Using a Simple In Vitro Inhibition Screen
Study date
1997
Auth party contact address
-
Data no
262553
Title
Appendix 40.1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262554
Title
Appendix 42.1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262555
Title
Appendix 43a.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262599
Title
508038
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262589
Title
Pharmacology
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262712
Title
Population pharmacokinetics of ropinirole in patients with Parkingson's disease
Study date
1997
Auth party contact address
-
Data no
262604
Title
13000068
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262605
Title
14000043
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262556
Title
Appendix 49
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262539
Title
Appendix 2.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262540
Title
Appendix 3.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262541
Title
Appendix 3.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262542
Title
Appendix 4.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262543
Title
Appendix 4.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262544
Title
Appendix 4.3
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262545
Title
Appendix 4.4
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262546
Title
Appendix 4.5
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262547
Title
Appendix 4.6
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262548
Title
Appendix 5.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262549
Title
Appendix 5.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262562
Title
The action potential in mammalian central neurons
Study date
2007
Auth party contact address
-
Data no
262563
Title
Drug Tolerance: A Known Unknown in Translational Neuroscience
Study date
2016
Auth party contact address
-
Data no
262598
Title
508037
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262670
Title
Tolerance in target animal species
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262675
Title
13000068
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262676
Title
14000043
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262672
Title
508037
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262718
Title
Prolactin in Canine and Feline Reproduction
Study date
1997
Auth party contact address
-
Data no
262716
Title
Cardiovascular and Electrocardiographic Effects of the Dopamine Receptor Agonists Ropinirole, Apomorphine, and PNU-142774E in Conscious Beagle Dogs
Study date
2006
Auth party contact address
-
Data no
262593
Title
Environmental impact assessment
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262817
Title
Clevor - IB-0008 - AR
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262818
Title
Project Plan - signed by applicant - 140059
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262819
Title
2023-10-12 - PAA meeting record and written advice - 140059 -FINAL
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262820
Title
clevor-epar-spc-prod-info_en
Study date
2018
Auth party contact address
-
Data no
262821
Title
Clevor_International Documentation Summary
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262822
Title
Clevor - EU Dossier Cross-Reference Table
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262823
Title
GMP certificates
Study date
2022
Auth party contact address
-
Data no
273852
Title
GMP certificate
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275514
Title
Ropinirole Safety Data Sheet
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262850
Title
Previous versions of EU dossier not expected to be relied upon.
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262824
Title
Clevor - D120 SO and LoQ
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262825
Title
Clevor - D180 SO and LoOI
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262826
Title
Clevor - D210 CVMP assessment report
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262827
Title
Clevor - V-004417-PAR-en
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262828
Title
Clevor IB-0002 - Rapp AR
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262829
Title
Clevor II-0005-G - Rapporteur assessment report
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262572
Title
Clevor - D180 LoOI Responses
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262536
Title
Clevor - response template - D120
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262632
Title
Single-dose ropinirole hydrochloride toxicity study in rats and monkeys
Study date
1996
Auth party contact address
-
Data no
262600
Title
511188
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262607
Title
Neoplastic Lesions of Questionable Significance to Humans
Study date
1994
Auth party contact address
-
Data no
262617
Title
Endometrial Stromal Polyps in Rodents: Biology, Etiology, and Relevance to Disease in Women
Study date
2012
Auth party contact address
-
Data no
262614
Title
Update on genotoxicity and carcinogenicity testing of 472 marketed pharmaceuticals
Study date
2009
Auth party contact address
-
Data no
262625
Title
Hyperplastic Endometrial Polyps in the Dog and Cat
Study date
1984
Auth party contact address
-
Data no
262646
Title
Product Monograph
Study date
2008
Auth party contact address
-
Data no
262662
Title
Ropinirole: Oral Reproductive and Developmental Toxicity Studies in Rats and Rabbits
Study date
1996
Auth party contact address
-
Data no
262663
Title
An exploratory retrospective evaluation of ropinirole-associated psychotic symptoms in an outpatient population treated for restless legs syndrome or Parkinson's disease
Study date
2009
Auth party contact address
-
Data no
262651
Title
Cytogenetic, Biochemical and Histopathological Effects of Ropinirole on Albino Male Mice
Study date
2015
Auth party contact address
-
Data no
262591
Title
Other requirements
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262601
Title
8333410
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262602
Title
8333411
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262537
Title
Appendix 1a.1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262538
Title
Appendix 1b.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262551
Title
Appendix 38.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262552
Title
Appendix 38.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262573
Title
Appendix 1.1
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262574
Title
Appendix 1.2
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262575
Title
Appendix 1.3
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262594
Title
Residue tests
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262595
Title
Identification of the product
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262596
Title
Metabolism and residue kinetics
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262597
Title
Residue analytical method
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262590
Title
Toxicology
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262588
Title
Precise identification of the product and its active substance
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262592
Title
User risk assessment
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262611
Title
Population pharmacokinetics of ropinirole in patients with Parkingson's disease
Study date
1997
Auth party contact address
-
Data no
262612
Title
In vitro identification of the P450 enzymes responsible for the metabolism of ropinirole
Study date
1997
Auth party contact address
-
Data no
262608
Title
Nanocarrier for the Transdermal Delivery of an Antiparkinsonian Drug
Study date
2009
Auth party contact address
-
Data no
262609
Title
Oil based nanocarrier system for transdermal delivery of ropinirole: A mechanistic, pharmacokinetic and biochemical investigation
Study date
2012
Auth party contact address
-
Data no
262618
Title
ADMET considerations for restless leg syndrome drug treatments
Study date
2012
Auth party contact address
-
Data no
262619
Title
New prospective in treatment of Parkinson's disease: Studies on permeation of ropinirole through buccal mucosa
Study date
2012
Auth party contact address
-
Data no
262621
Title
Pregnancy outcome following use of levodopa, pramipexole, ropinirole, and rotigotine for restless legs syndrome during pregnancy: a case series
Study date
2013
Auth party contact address
-
Data no
262622
Title
Preclinical Pharmacology of Ropinirole (SK F 101468-A) a Novel Dopamine D2 Agonist
Study date
1991
Auth party contact address
-
Data no
262652
Title
SDS 1
Study date
2015
Auth party contact address
-
Data no
262653
Title
SDS 2
Study date
2015
Auth party contact address
-
Data no
262654
Title
SDS 3
Study date
2014
Auth party contact address
-
Data no
262655
Title
SDS 4
Study date
2016
Auth party contact address
-
Data no
262656
Title
Treatment of Disorders of Bowel Motility and Water Flux; Anti-Emetics; Agents Used in Biliary and Pancreatic Disease
Study date
2011
Auth party contact address
-
Data no
262657
Title
Update on ropinirole in the treatment of Parkinson's disease
Study date
2009
Auth party contact address
-
Data no
262658
Title
Controlled delivery of ropinirole hydrochloride through skin using modulated iontophoresis and microneedles
Study date
2013
Auth party contact address
-
Data no
262659
Title
Movement disorders in pregnancy
Study date
2004
Auth party contact address
-
Data no
262660
Title
Repeat-Dose Oral Toxicity of Ropinirole in Cynomolgus Monkeys
Study date
1996
Auth party contact address
-
Data no
262661
Title
Repeat-Dose Oral Toxicity of Ropinirole in Rats
Study date
1996
Auth party contact address
-
Data no
262664
Title
Pharmacokinetics of Dopamine-2 Agonists in Rats and Dogs
Study date
1986
Auth party contact address
-
Data no
262647
Title
Disposition of ropinirole in animals and man
Study date
1999
Auth party contact address
-
Data no
262649
Title
Comparative Pharmacological Study of Ropinirole (SKF-101468) and its Metabolites in Rats
Study date
2000
Auth party contact address
-
Data no
262650
Title
RIVM report
Study date
2023
Auth party contact address
-
Data no
262626
Title
Globally harmonized system of classification and labelling of chemicals (GHS)
Study date
2011
Auth party contact address
-
Data no
262615
Title
Comparison of the functional potencies of ropinirole and other dopamine receptor agonists at human D2(long), D3 and D4.4 receptors expressed in Chinese hamster ovary cells
Study date
1999
Auth party contact address
-
Data no
262628
Title
Cardiovascular and Electrocardiographic Effects of the Dopamine Receptor Agonists Ropinirole, Apomorphine, and PNU-142774E in Conscious Beagle Dogs
Study date
2006
Auth party contact address
-
Data no
262629
Title
Dopamine receptor agonists differ in their actions on cardiac ion channels
Study date
2003
Auth party contact address
-
Data no
262633
Title
Clinical Pharmacokinetics of Ropinirole
Study date
2000
Auth party contact address
-
Data no
262634
Title
Formulation of intranasal mucoadhesive temperature-mediated in situ gel containing ropinirole and evaluation of brain targeting efficiency in rats
Study date
2010
Auth party contact address
-
Data no
262635
Title
Ropinirole: a dopamine agonist for the treatment of Parkinson's disease
Study date
1999
Auth party contact address
-
Data no
262636
Title
Intranasal and Subcutaneous Administration of Dopamine D3 Receptor Agonists Functionally Restores Nigrostriatal Dopamine in MPTP-Treated Mice
Study date
2013
Auth party contact address
-
Data no
262637
Title
Functional group metabolism of dopamine-2 agonists: conversion of 4-(2-di-n-propylaminoethyl)-2-(3H)-indolone to 4-(2-di-n-propylaminoethyl)-7-hydroxy-2-(3H)-indolone
Study date
1986
Auth party contact address
-
Data no
262638
Title
OECD Guideline for the Testing of Chemicals - Acute Dermal Irritation Corrosion
Study date
2002
Auth party contact address
-
Data no
262639
Title
OECD Guideline for the Testing of Chemicals - Acute Eye Irritation Corrosion
Study date
2012
Auth party contact address
-
Data no
262640
Title
OECD Guideline for the Testing of Chemicals - Skin Sensitization Local Lymph Node Assay
Study date
2010
Auth party contact address
-
Data no
262641
Title
OECD Guideline for the Testing of Chemicals - Bacterial Reverse Mutation Test
Study date
1997
Auth party contact address
-
Data no
262642
Title
OECD Guideline for the Testing of Chemicals - In Vitro Mammalian Chromosomal Aberration Test
Study date
1997
Auth party contact address
-
Data no
262643
Title
OECD assessment report for excipient
Study date
2002
Auth party contact address
-
Data no
262830
Title
Ropinirole - Literature Review
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262831
Title
A placebo-controlled evaluation of ropinirole, a novel D2 agonist, as sole dopaminergic therapy in Parkinson's Disease
Study date
1998
Auth party contact address
-
Data no
262833
Title
Ropinirole for levodopa-induced complications in Parkinson's Disease (Review).
Study date
2001
Auth party contact address
-
Data no
262834
Title
High-dose therapy with ropinirole in patients with Parkinson's Disease.
Study date
2001
Auth party contact address
-
Data no
262835
Title
High-dose ropinirole in advanced Parkinson's Disease with severe dyskinesias.
Study date
2003
Auth party contact address
-
Data no
262836
Title
Comparison of the risk of adverse events with pramipexole and ropinirole in patients with Parkinson's Disease. A meta-analysis.
Study date
2003
Auth party contact address
-
Data no
262837
Title
Ropinirole as an adjunct to levodopa in the treatment of Parkinson's Disease. A 16-week bromocriptine controlled study.
Study date
2003
Auth party contact address
-
Data no
262838
Title
Ropinirole therapy for Parkinson's Disease.
Study date
2004
Auth party contact address
-
Data no
262839
Title
Ropinirole in the treatment of restless leg syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries.
Study date
2004
Auth party contact address
-
Data no
262840
Title
Ropinirole is effective in the long-term management of restless leg syndrome: a randomized controlled trial.
Study date
2006
Auth party contact address
-
Data no
262841
Title
A review of ropinirole prolonged release in Parkinson's Disease.
Study date
2009
Auth party contact address
-
Data no
262842
Title
Tolerability and safety of ropinirole versus other dopamine agonists and levodopa in the treatment of Parkinson's disease. Meta-analysis of randomized controlled trials.
Study date
2010
Auth party contact address
-
Data no
262843
Title
A fatal intoxication case involving ropinirole.
Study date
2012
Auth party contact address
-
Data no
262844
Title
Indirect comparisons of adverse events and dropout rates in early Parkinson's Disease trials of pramipexole, ropinirole and rasagiline.
Study date
2012
Auth party contact address
-
Data no
262845
Title
Drug safety evaluation of ropinirole prolonged release.
Study date
2014
Auth party contact address
-
Data no
262846
Title
Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's Disease.
Study date
2016
Auth party contact address
-
Data no
262847
Title
The effect and safety of ropiniorle in the treatment of Parkinson Disease. A systematic review and meta-analysis.
Study date
2021
Auth party contact address
-
Data no
262848
Title
Ropinirole Product Monograph
Study date
2017
Auth party contact address
-
Data no
262849
Title
Prevalence of nausea and vomiting in adults using ropinirole: a systematic review and meta-analysis.
Study date
2017
Auth party contact address
-
Data no
262851
Title
Ropinirole: current status of the studies.
Study date
2004
Auth party contact address
-
Data no
273850
Title
Preclinical Evaluation of Application for Registration 1
Study date
1996
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
273851
Title
Nonclinical Evaluation Report 2
Study date
2003
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262811
Title
Medicines Complete Database
Study date
2023
Auth party contact address
-
Data no
262644
Title
Letter to the Editor (Case report)
Study date
2008
Auth party contact address
-
Data no
262645
Title
Othello Syndrome Secondary to Ropinirole: A Case Study
Study date
2008
Auth party contact address
-
Data no
262630
Title
Adverse Effects of Ropinirole-Treated Restless Leg Syndrome (RLS) During Smoking Cessation
Study date
2008
Auth party contact address
-
Data no
262631
Title
Ropinirole in the treatment of restless legs syndrome
Study date
2005
Auth party contact address
-
Data no
262616
Title
Effectiveness of ropinirole for RLS and depressive symptoms in an 11-year-old girl
Study date
2009
Auth party contact address
-
Data no
262627
Title
Ten-Year Follow-Up of Parkinson's Disease Patients Randomized to Initial Therapy with Ropinirole or Levodopa
Study date
2007
Auth party contact address
-
Data no
262648
Title
A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa
Study date
2000
Auth party contact address
-
Data no
262665
Title
Ropinirole-Induced Symptomatic Sinus Node Dysfunction
Study date
2008
Auth party contact address
-
Data no
262666
Title
Ropinirole in the treatment of Parkinson's disease
Study date
1999
Auth party contact address
-
Data no
262667
Title
The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: A multicenter, double-blind, randomized, placebo-controlled study-
Study date
2013
Auth party contact address
-
Data no
262623
Title
Falling asleep at the wheel: motor vehicle mishaps in persons taking pramipexole and ropinirole
Study date
1999
Auth party contact address
-
Data no
262624
Title
A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome
Study date
2007
Auth party contact address
-
Data no
262620
Title
Rare and Serious Cardiac Side Effects During Ropinirole Titration
Study date
2010
Auth party contact address
-
Data no
262610
Title
Ropinirole Monotherapy Induced Severe Reversible Dyskinesias in Parkinson's Disease
Study date
2013
Auth party contact address
-
Data no
262613
Title
Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial
Study date
2006
Auth party contact address
-
Data no
262606
Title
Pathological behaviors provoked by dopamine agonist therapy of Parkinson's disease
Study date
2011
Auth party contact address
-
Date
Application Date
Application No
Application Number
142314
Product/Active constituent Name
Application Product Name
TRIATHLON HERBICIDE
Application Date
Application Number
142314
Application Product Name
TRIATHLON HERBICIDE
Application details
Product name:
TRIATHLON HERBICIDE
Product number:
68602
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to add an alternate formulation and add Bifora control.
Active constituents:
Active constituent name
44369 - BROMOXYNIL OCTANOATE
Active constituent name
54290 - DIFLUFENICAN
Active constituent name
54557 - BROMOXYNIL OCTANOATE
Active constituent name
51603 - MCPA
Description of data provided:
Data no
263780
Title
Emulsification Stability of Triathlon EC
Study date
21 Jul 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263776
Title
Safety Data Sheet for raw materials
Study date
Sep 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263777
Title
Manufacturing method for TRIATHLON EC
Study date
17 July 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263778
Title
Report of Analysis
Study date
8 Dec 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263774
Title
Part-2 Chemistry and Manufacture
Study date
Sep 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263775
Title
TRIATHLON Herbicide Draft Label - Highlighted version
Study date
Dec 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263779
Title
QU-0370: Storage Stability of TRIATHLON, revision 1. Appendix-1 Analytical method and method validation for QCM-246.01
Study date
12 Dec 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263781
Title
Part-8 Efficacy and Safety
Study date
Dec 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263783
Title
AD-AU-22-H16-3: AD-AU-2212 275 EC and AD-AU-2213 425 EC for broadleaf weed control in wheat cv. Vixen, Roseworthy, South Australia, 2022
Study date
23 Feb 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263784
Title
AD-AU-22-H16-4: Evaluation of AD-AU-2212 and AD-AU-2213 for broadleaf weed control in pasture, Location: Buckley, Victoria
Study date
24 Jul 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263785
Title
AD-AU-22-H16-2: Evaluation of AD-AU-2212 and AD-AU-2213 for broadleaf weed control in cereals, Naraling, Western Australia, 2022
Study date
16 Nov 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263786
Title
Triathlon Herbicide draft label - Highlighted version
Study date
Dec 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
263782
Title
AD-AU-22-H16-1: Crop safety of AD-AU-2212 275 EC, AD-AU-2213 425 EC and AD-AU-2214 400 EC, applied post emergent in various cereals, Roseworthy, South Australia, 2022
Study date
23 Feb 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
142337
Product/Active constituent Name
Application Product Name
Nufarm Intervene Fungicide
Application Date
Application Number
142337
Application Product Name
Nufarm Intervene Fungicide
Application details
Product name:
Nufarm Intervene Fungicide
Product number:
90033
Applicant Name:
Kaken Pharmaceutical Co., Ltd.
Application purpose and description of use:
Variation of product registration and label approval to add new crops (cherries, fruiting vegetable - cucurbits and herbs) and a new disease (shot hole) in almonds. This application includes uses that if granted, may trigger an extension to the limitation period.
Active constituents:
Active constituent name
88809 - POLYOXIN D ZINC SALT
Description of data provided:
Data no
263973
Title
Evaluation of NUL3446 for the Control of Shot Hole in Almonds
Study date
June 23
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263974
Title
Evaluation of NUL3446 for the Control of Shot Hole in Almonds
Study date
June 23
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263975
Title
Evaluation of NUL3446 for the Control of Shot Hole in Almonds
Study date
March 23
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263976
Title
Efficacy of Miravis Prime 400 SC and Intervene 113 WG for control of grey mould (Botrytis cinerea) and Alternaria (Alternaria alternata) in sweet cherries cv. Sweet Heart Castle Forbes Bay, Tasmania
Study date
23 June 2022
Auth party contact address
45 King Street, Bowen Hills QLD 4006
Data no
263977
Title
Efficacy of Miravis Prime 400 SC and Intervene 113 WG for control of grey mould (Botrytis cinerea) and brown rot (Monilinia fructicola) in sweet cherries cv. Simone Hillwood, Tasmania
Study date
23 June 2022
Auth party contact address
45 King Street, Bowen Hills QLD 4006
Data no
263978
Title
Efficacy of NUL3446 113 WG for control of grey mould (Botrytis cinerea) in sweet cherries cv. Staccato
Study date
16 May 2022
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263979
Title
Efficacy of NUL3446 113 WG for control of grey mould (Botrytis cinerea) in sweet cherries cv. Simmone, Hillwood, Tasmania
Study date
16 May 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263980
Title
Efficacy Screen ??? Gummy Stem Cucurbits
Study date
May 2021
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263981
Title
Evaluation of NUL3446 for the control of gummy stem in Rockmelon
Study date
21 Dec 2022
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263982
Title
To evaluate NUL3446 for the control of gummy stem blight (Didymella bryoniae) in rockmelon cv. Jamaica. Rubyanna / Queensland / 2022
Study date
08-Dec 2022
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263983
Title
Evaluation of NUL3446 for the control of Gummy Stem in Cucurbits
Study date
09 Dec 2022
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263984
Title
Evaluation of NUL3446 for the control of Gummy Stem in Cucurbits
Study date
15 Dec 2022
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263985
Title
Evaluation of NUL3446 for the control of gummy stem in cucurbits Gatton, QLD, 2022
Study date
8 May 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263986
Title
Evaluation of NUL3446 for crop safety in cucurbits. One field trial, Lower Tenthill, Queensland, Australia, 2022
Study date
3 Feb 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263987
Title
Evaluation of NUL3446 for crop safety in cucurbits. One field trial, Lawes, Queensland, Australia, 2022
Study date
3 Feb 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263988
Title
Evaluation of NUL3446 for crop safety in cucurbits. One field trial. Shepparton, Victoria, Australia, 2022
Study date
1 Mar 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263989
Title
Evaluation of NUL3446 113 WG for control of powdery mildew (Golovinomyces monardae) and Botrytis blight (Botrytis cinerea) in thyme herb. Don, Tasmania, 2023
Study date
14 August 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263990
Title
Evaluation of NUL3446 113 WG for control of Botrytis blight (Botrytis cinerea) in sweet basil cv. Marion Don, Tasmania, 2023
Study date
20 July 2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Data no
263991
Title
NUFARM INTERVENE LABEL EXTENSION FOR ALMONDS, CHERRIES, CUCURBITS AND HERBS PART 8 EFFICACY AND CROP SAFETY
Study date
Dec 2023
Auth party contact address
28-8, Honkomagome 2-chome Bunkyo-ku Japan
Data no
263972
Title
Nufarm Intervene Fungicide Marked Up Label
Study date
14-12-2023
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Date
Application Date
Application No
Application Number
142363
Product/Active constituent Name
Application Product Name
Campbell Chino 400SC Turf Fungicide
Application Date
Application Number
142363
Application Product Name
Campbell Chino 400SC Turf Fungicide
Application details
Product name:
Campbell Chino 400SC Turf Fungicide
Product number:
94408
Applicant Name:
COLIN CAMPBELL (CHEMICALS) PTY LTD
Application purpose and description of use:
Registration of a 400g/L cyazofamid as a suspension concentrate product for control of Pythium diseases in turf.
Reference details:
86803 - Segway 400 SC Fungicide
Active constituents:
Active constituent name
93499 - cyazofamid
Description of data provided:
Data no
264027
Title
C of A for the active
Study date
11 December 2023
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264028
Title
SDS for inerts in the formulation
Study date
November 2023
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264029
Title
Formulation Process
Study date
December 2023
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264026
Title
Determination of Relative Density of Cyazofamid 400 g/L SC
Study date
12 September 2023
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264030
Title
Final Report Accelerated Storage Stability of Cyazofamid 400 g/L SC
Study date
1 September 2023
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264031
Title
Final Report Low Temperature Stability of Cyazofamid 400 g/L SC
Study date
7 September 2023
Auth party contact address
9th Floor, Arliga NorthStar Opposite Police Station (Beside RMZ Galleria Mall)Yelahanka, Bangalore 560064. Karnataka INDIA
Data no
264023
Title
Evaluation of fungicides for control of Pythium spp in turf - 2022
Study date
29 June 2022
Auth party contact address
5 Blackfriar Place WETHERILL PARK Australia
Data no
264024
Title
Evaluation of fungicides for control of Pythium spp in turf - 2023
Study date
4 July 2023
Auth party contact address
5 Blackfriar Place WETHERILL PARK Australia
Data no
264025
Title
Part 8 Efficacy Summary
Study date
2023
Auth party contact address
5 Blackfriar Place WETHERILL PARK Australia
Date
Application Date
Application No
Application Number
141689
Product/Active constituent Name
Application Product Name
SEDdex Injection
Application Date
Application Number
141689
Application Product Name
SEDdex Injection
Application details
Product name:
SEDdex Injection
Product number:
94143
Applicant Name:
PARNELL TECHNOLOGIES PTY LTD
Application purpose and description of use:
Registration of a Dexmedetomidine Hydrochloride Injection, 0.5 mg/mL, 10 mL vial. Intended for use as a Sedative, analgesic for use in the restraint of dogs and cats.
Reference details:
64563 - DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS
Active constituents:
Active constituent name
94144 - Dexmedetomidine hydrochloride
Description of data provided:
Data no
263454
Title
GMP Evidence
Study date
7 November 2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
263455
Title
GMP Evidence
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
272727
Title
Stability Data-Attachment 1
Study date
Oct 23
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
272728
Title
Prpoposed Specification-Attachemnt 2
Study date
May 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260211
Title
Finished Product_Manufacturer GMP_Drug Establishments Current Registration Site
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271693
Title
Parnell response-Attachment 1
Study date
October 2019
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260212
Title
Flow Diagram of Dexmedetomidine Hydrochloride Injection (Compounding and Filling)
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260208
Title
Cover letter_Applicable to Dexmedetomidine Hydrochloride Injection
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
260210
Title
Exeutive summary_Dexmedetomidine Hydrochloride Injection
Study date
July 2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271694
Title
Exeutive summary_Dexmedetomidine Hydrochloride Injection
Study date
July 2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271695
Title
Parnell response-Attachment 3
Study date
April 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271692
Title
s159-Parnell?s response letter-Word file
Study date
April 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
272726
Title
s8-Parnell?s response letter-PDF file
Study date
May 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271696
Title
Parnell response-GMP-Attachment 4
Study date
April 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date
Application Date
Application No
Application Number
141924
Product/Active constituent Name
Application Product Name
CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats
Application Date
Application Number
141924
Application Product Name
CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats
Application details
Product name:
CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats
Product number:
94258
Applicant Name:
PARNELL TECHNOLOGIES PTY LTD
Application purpose and description of use:
Registration of a CONTRASED Specific reverser of medetomidine and dexmedetomidine for dogs and cats (5 mg /mL ATIPAMEZOLE HYDROCHLORIDE) solution for injection. The finished product contains 5 mg /mL ATIPAMEZOLE HYDROCHLORIDE per mL, intended for use as reversing and abolishing the effects of medetomidine.
Reference details:
40612 - ANTISEDAN SPECIFIC REVERSER OF MEDETOMIDINE AND DEXMEDETOMIDINE FOR DOGS AND CATS
Description of data provided:
Data no
261829
Title
Flow Diagram_CONTRASED
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
261826
Title
Cover letter_Applicable to CONTRASED
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
261828
Title
Exeutive summary_CONTRASED
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date
Application Date
Application No
Application Number
141927
Product/Active constituent Name
Application Product Name
Atipamezole hydrochloride
Application Date
Application Number
141927
Application Product Name
Atipamezole hydrochloride
Application details
Product name:
Atipamezole hydrochloride
Active name:
Atipamezole hydrochloride
Applicant Name:
PARNELL TECHNOLOGIES PTY LTD
Application purpose and description of use:
New source of active constituent
Description of data provided:
Data no
262933
Title
COA_Atipamezole Hydrochloride
Study date
March 2020
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
263729
Title
Atipamezole hydrochloride CoAs
Study date
2022
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271861
Title
COA-API Supplier
Study date
Nov 2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271862
Title
Parnell response-Attachment 1
Study date
September 2021
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
271860
Title
s159-Parnell?s response letter-Word file
Study date
May 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date
Application Date
Application No
Application Number
142028
Product/Active constituent Name
Application Product Name
Greenzone Termite Paint
Application Date
Application Number
142028
Application Product Name
Greenzone Termite Paint
Application details
Product name:
Greenzone Termite Paint
Product number:
93121
Applicant Name:
GREEN ZONE PTY LTD
Application purpose and description of use:
Variation of the product registration and label approval of a product, Greenzone Termite Paint (93121), to remove the exclusion of Mastotermes darwiniensis from the Directions for Use table.
Reference details:
61290 - HOMEGUARD COLLARS
62739 - TERM-SEAL SEALANT ACTIVE TERMITE AND WATERPROOF BARRIER
62740 - TERM-SEAL MULTI-PURPOSE ACTIVE TERMITE AND WATERPROOF BARRIER
62741 - TERM-SEAL PRM ACTIVE TERMITE AND WATERPROOF BARRIER
63002 - TERM-SEAL URA-FEN ACTIVE TERMITE BARRIER
63003 - TERM-SEAL URA-FEN MAJOR TERMITE BARRIER PART B
64037 - TERM-SEAL URA-FEN SHIELD TWB TERMITE AND WATERPROOF BARRIER
70455 - TERM-SEAL URA-FEN TERMITE RESISTANT ADHESIVE
80186 - TERM-SEAL AQUA BLOCK PLUS SEALANT TERMITE BARRIER
80607 - TERM-SEAL AQUA BLOCK PLUS TERMITE BARRIER
82052 - Trithor Maxx Contact Adhesive Spray
82052 - Trithor Maxx Termiticidal Contact Adhesive Spray
89294 - Greenzone Perimeter System
89294 - Greenzone Termite Perimeter System
Active constituents:
Active constituent name
55301 - BIFENTHRIN
Description of data provided:
Data no
262266
Title
8.0 Efficacy Dossier
Study date
November 2023
Auth party contact address
25, 479 Warrical Road Moorabbin East Australia
Data no
262265
Title
1.1 Executive Summary
Study date
November 2023
Auth party contact address
25, 479 Warrical Road Moorabbin East Australia
Date
Application Date
Application No
Application Number
142336
Product/Active constituent Name
Application Product Name
Tri-Sulfox Injection
Application Date
Application Number
142336
Application Product Name
Tri-Sulfox Injection
Application details
Product name:
Tri-Sulfox Injection
Product number:
91644
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration Tri-Sulfox Injection for minor formulation variation.
Active constituents:
Active constituent name
89577 - Sulfadoxine
Active constituent name
83554 - Trimethoprim
Description of data provided:
Data no
271079
Title
Certificate of Analysis
Study date
12/03/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
263960
Title
Formulation sheet
Study date
01/12/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
263961
Title
Finished Product Specification
Study date
20/09/2021
Auth party contact address
71 Milperra Road Revesby Australia
Data no
271080
Title
Tri-Sulfox Inj letter
Study date
22/03/2024
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
142327
Product/Active constituent Name
Application Product Name
IMTRADE MOTTO RMR MITICIDE
Application Date
Application Number
142327
Application Product Name
IMTRADE MOTTO RMR MITICIDE
Application details
Product name:
IMTRADE MOTTO RMR MITICIDE
Product number:
92373
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to allow application by fixed-wing aircraft to Cotton only.
Active constituents:
Active constituent name
89349 - Etoxazole
Active constituent name
65954 - PIPERONYL BUTOXIDE
Description of data provided:
Data no
269524
Title
Investigation into the Bio-equivalency of IMTRADE MOTTO? RMR? MITICIDE to that of PARAMITE SELECTIVE MITICIDE for the control of Mites in Cotton cv. Sicot 711RRF. One Trial - Forest Hill, QLD
Study date
27/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
269525
Title
Field Trial Protocol - Investigation into the efficacy of Imtrade Motto RMR Miticide for the control of mites in cotton as an aerial application
Study date
26/03/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
263940
Title
Imtrade MOTTO?? RMR?? Miticide - RLP_V1 MARKED COPY 14/12/2023
Study date
14/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
263938
Title
Environmental Technical Report App 135307 Imtrade MOTTO RMR Miticide
Study date
04/09/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
263939
Title
Further Assessment of Imtrade Motto RMR Miticide
Study date
14/12/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
142330
Product/Active constituent Name
Application Product Name
Mecoprop-P
Application Date
Application Number
142330
Application Product Name
Mecoprop-P
Application details
Product name:
Mecoprop-P
Active name:
Mecoprop-P
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of MECOPROP-P Technical for use in agricultural chemical products.
Description of data provided:
Data no
263946
Title
PRELIMINARY ANALYSIS OF MECOPROP-P (MCPP-P) TECHNICAL GRADE ACTIVE INGREDIENT (TGAI)
Study date
April 25, 2014
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263947
Title
POL YCHLORINATED DIBENZODIOXINS AND POL YC HLORINATED DIBENZOFURANS ANALYSIS OF MECOPROP-P (MCPP-P) TGAI
Study date
April 25, 2014
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263950
Title
Doc
Study date
2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263951
Title
The Statement of Batch Size of PaclobutrazolTechnical in 5-Batch Report
Study date
2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263952
Title
CoA
Study date
2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
273746
Title
Test QC results of Mecoprop-P Technical in the random samples produced in 2024
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263948
Title
MANUFACTURE PROCESS OF MECOPROP-P Technical
Study date
2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263945
Title
Chemistry &Manufacturing Dossier
Study date
14/12/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
263949
Title
THE JUSTIFICATION OF IMPURITIES OF MECOPROP-P Technical
Study date
2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China