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
142287
Product/Active constituent Name
Application Product Name
SPINOGEL ORGANIC COCKROACH GEL
Application Date
Application Number
142287
Application Product Name
SPINOGEL ORGANIC COCKROACH GEL
Application details
Product name:
SPINOGEL ORGANIC COCKROACH GEL
Product number:
94383
Applicant Name:
SUNDEW SOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 10 g/kg spinosad ready to use bait for the control of cockroaches
Reference details:
91766 - SpinaFLEX Insecticide
Active constituents:
Active constituent name
89208 - SPINOSAD
Description of data provided:
Data no
263694
Title
CoA Spinosad Qilu Pharmaceutical document
Study date
16 June 2021
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263692
Title
Method AM-23-31: Determination of Spinosad in RF-086 and RF-089 Bait Formulations
Study date
6 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263693
Title
Validation of an Analytical Method for Determining Spinosad Content in RF-086 and RF-089
Study date
5 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263688
Title
Manufacturing and QC procedures for RF-089
Study date
6 December 2023
Auth party contact address
4 Swans Road Bell Block, New Plymouth 4312 New Zealand
Data no
263689
Title
Physical and chemical properties of RF-089
Study date
3 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263690
Title
Specification for RF-089 (1.05% w/w spinosad ready to use bait)
Study date
6 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263685
Title
Part 2 chemistry and manufacture
Study date
6 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263686
Title
SDS for Non-Active Constituents for RF-089
Study date
6 December 2023
Auth party contact address
4 Swans Road Bell Block, New Plymouth 4312 New Zealand
Data no
263687
Title
Composition of RF-089
Study date
6 December 2023
Auth party contact address
4 Swans Road Bell Block, New Plymouth 4312 New Zealand
Data no
263691
Title
Accelerated Stability of RF-089 (1.05% w/w Spinosad Ready To Use Bait) in MDPE Packaging for 8 weeks at 40??C
Study date
5 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263695
Title
Spinogel Part 8 Efficacy
Study date
6 December 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263696
Title
Trial to investigate efficacy of Spinogel Organic Cockroach Gel (10g/kg spinosad) against German cockroaches in the laboratory
Study date
16 September 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263697
Title
Trial to investigate efficacy of Spinogel Organic Cockroach Gel (10g/kg spinosad) against American cockroaches in the laboratory
Study date
30 September 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
279809
Title
Renovo Spinogel response
Study date
17 October 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
279810
Title
Sundew Spinogel response
Study date
25 October 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
279811
Title
Further Spinogel response
Study date
24 October 2024
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Data no
263684
Title
Spinogel AA letter
Study date
22 November 2023
Auth party contact address
UNIT 11, 4 DUNLOP COURT BAYSWATER Australia
Date
Application Date
Application No
Application Number
142418
Product/Active constituent Name
Application Product Name
THIOPRON FUNGICIDE
Application Date
Application Number
142418
Application Product Name
THIOPRON FUNGICIDE
Application details
Product name:
THIOPRON FUNGICIDE
Product number:
94432
Applicant Name:
UPL AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 825g/L sulphur suspension concentrate product for use in grapevines and tomatoes for the control of powdery mildew and mites.
Reference details:
51784 - MICROTHIOL DISPERSS WETTABLE SULPHUR FUNGICIDE, MITICIDE AND INSECTICIDE
62282 - UNISHIELD FUNGICIDE, MITICIDE AND INSECTICIDE
Description of data provided:
Data no
264241
Title
Sulphur Certificate of Analysis
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264240
Title
Validation of an Analytical Method for the Determination of active ingredient content of Sulphur 825 SC
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279861
Title
Validation of SOP DLA-240.2 version 2 Microthiol Special Liquide determination of active ingredient
Study date
2005
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264237
Title
Product Manufacturing Documents
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264238
Title
Certificate of Composition
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264242
Title
Document J
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279856
Title
Thiopron Manufacturing information
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279857
Title
Thiopron QC manufacturing specifications
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279858
Title
Certificate of Analysis
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279859
Title
Thiopron regulatory specifications
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279860
Title
Thiopron manufacturing process description
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264236
Title
Part 2 - Chemistry and Manufacture Dossier
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264239
Title
Physical, chemical and technical properties of Sulphur 825 g/1 (FCG70) including accelerated storage stability
Study date
2020
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
279862
Title
Shelf-life of Microthiol Special Liquid 825 g/l SC in commercial container for 2 years at ambient storage conditions.
Study date
2007
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264267
Title
Sulphur Options Rates Grape Trial
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264268
Title
An evaluation of various sulphur products for their efficacy against Powdery Mildew (Uncinula necator) in Grapes
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264269
Title
Efficacy of Sulphur Options for Powdery Mildew Control in Grapes
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264270
Title
Evaluation of Sulphur and Adjuvant options in Grapes for the control of Powdery Mildew
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264254
Title
BIOEQUIVALENCE OF THIOPRON SULPHUR TO MICROTHIOL DISPERSS WETTABLE SULPHUR FOR POWDERY MILDEW CONTROL IN GRAPES
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264255
Title
Bioequivalence of THIOPRON Sulphur and Microthiol Disperss for control of powdery mildew (caused by Erysiphe necator) in grapevines cv. Merlot
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264256
Title
Comparison of THIOPRON 825 SC with Microthiol 800 DF for the control of powdery mildew (Erysiphe necator) in grapevines cv. Verdelho
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264257
Title
BIOEQUIVALENCY OF THIOPRON SULPHUR TO MOCROTHIOL DISPERSS WETTABLE SULPHUR FOR POWDERY MILDEW CONTROL IN GRAPES
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264258
Title
Powdery Mildew ??? Tomatoes. Determine the Bioequivalence of THIOPRON Sulphur to Microthiol Disperss Wettable Sulphur for Powdery Mildew control in Tomatoes.
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264259
Title
Two Spotted Mite ??? Tomatoes. Determine the Bioequivalence of THIOPRON Sulphur to Microthiol Disperss Wettable Sulphur for mite control in Tomatoes
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264260
Title
Efficacy of FFZ05 for control of powdery mildew (caused by Erysiphe necator) in grapevine cv. Cabernet
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264261
Title
Sulphur Options for Powdery Mildew Control in Grapes
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264262
Title
Sulphur Options for Powdery Mildew Control in Grapes
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264263
Title
An evaluation of various sulphur products for their efficacy againstPowdery Mildew (Uncinula necator) in Grapes
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264264
Title
Sulphur Options for Powdery Mildew Control in Grapes
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264265
Title
Sulphur Options and Actiwett for Powdery Mildew Control in Grapes
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264253
Title
Part 8: Efficacy and Safety Dossier
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264266
Title
Sulphur Options and Adjuvant Safety Grape Trial
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264248
Title
FCG08 - Sulfur 825 g/L SC: Chronic Oral Toxicity Test on the Honey Bee (Apis mellifera L.) in the Laboratory
Study date
2020
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264251
Title
Sulphur 825 g/L SC: Effects on Reproduction of Collembola (Folsomia candida) in Artificial Soil
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264249
Title
Sulphur 825 g/L SC: Effects on Reproduction of the Predatory Mite Hypoaspis aculeifer in Artificial Soil
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264250
Title
FCG08, Sulfur 825 g/l SC: Effects on the Activity of the Soil Microflora in the Laboratory (Nitrogen Transformation)
Study date
2019
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264247
Title
Part 7: Environment Dossier
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264252
Title
FCG08 Sulfur 825 g/L SC: Effects on Reproduction and Growth of Earthworms Eisenia andrei in Artificial Soil
Study date
2020
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264231
Title
Thiopron - proposed label
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264232
Title
Sulphur Technical Safety Data Sheet
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264233
Title
Thiopron Safety Data Sheet
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264234
Title
EFSA JOURNAL: CONCLUSION ON PESTICIDES PEER REVIEW. Peer review of the pesticide risk assessment of the active substance sulfur
Study date
2023
Auth party contact address
-
Data no
264235
Title
US-EPA: Sulfur. Summary of Human Health Risk Assessments to Support Registration Review. May 1, 2013.
Study date
2013
Auth party contact address
-
Data no
264246
Title
Sulfur 825 SC: Occupational exposure from application to grapevines in Australia
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264244
Title
Acute Inhalation Toxicity Study of Sulphur 825 SC in Rats
Study date
2021
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264245
Title
SKIN SENSITISATION STUDY OF SULPHUR 825 SC BY LOCAL LYMPH NODE ASSAY IN MICE
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
264243
Title
Part 4 - Health dossier
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date
Application Date
Application No
Application Number
142178
Product/Active constituent Name
Application Product Name
MASTIPLAN L.C. BROAD SPECTRUM LACTATING COW TREATMENT
Application Date
Application Number
142178
Application Product Name
MASTIPLAN L.C. BROAD SPECTRUM LACTATING COW TREATMENT
Application details
Product name:
MASTIPLAN L.C. BROAD SPECTRUM LACTATING COW TREATMENT
Product number:
94354
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 300mg cephapirin and 20 mg prednisolone as a homogeneous, sterile suspension intramammary product for the treatment of mastitis in lactating cows.
Reference details:
47091 - METRICURE BENZATHINE CEPHAPIRIN INTRA-UTERINE SUSPENSION
Active constituents:
Active constituent name
90798 - Cephapirin sodium
Active constituent name
90815 - Prednisolone
Description of data provided:
Data no
272711
Title
Prednisolone Certificate of Analysis.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263001
Title
Analytical Method and Validation Data.
Study date
2007
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262995
Title
Raw Materials Specifications and Certificates of Analysis.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262998
Title
Product Specifications.
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262999
Title
Batch Analysis.
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
272712
Title
Mastiplan Commitment - Finished Product Specifications
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262994
Title
Pharmaceutical Development.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262996
Title
Manufacturers and GMP Compliance.
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262997
Title
Manufacturing Process and In-Process Controls.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262993
Title
Description and Composition.
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263002
Title
Packaging Specifications.
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263003
Title
Mastiplan Chemistry and Manufacture
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
272713
Title
s159 Response Letter
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263000
Title
Stability Data.
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
278362
Title
Comparative efficacy of a mastitis preparation containing cefapirin mecillinam and prednisolone versus placebo treatment and Avuloxil in cows with experimentally infuced Staphylococcus aureus mastitis (pilot dose-finding). MSD Animal Health Study No. 93R/0334.
Study date
1993
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
278363
Title
MSD Response Letter to the APVMA Efficacy and Safety Enquiries.
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
278364
Title
Bovine Mastitis Bacteriology, Australian Standard Diagnostic Techniques for Animal Diseases.
Study date
1980
Auth party contact address
-
Data no
263238
Title
Overview of MIC?s of cephapirin against bovine mastitis pathogens. MSD Animal Health Study No. 00111-RE.
Study date
2000
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263239
Title
Minimal inhibitory concentrations against bovine mastitis bacterial strains isolated in a field trial. MSD Animal Health Study No. RE-08873.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263240
Title
Antimicrobial susceptibility monitoring of mastitis pathogens isolatedfrom acute cases of clinical mastitis in dairy cows across Europe: VetPath results.
Study date
2015
Auth party contact address
-
Data no
263241
Title
Antimicrobial resistance in Staphylococcus aureus, Streptococcus uberis and Streptococcus dysgalactiae from dairy cows with mastitis.
Study date
2013
Auth party contact address
-
Data no
263245
Title
Antibacterial effect of cephapirin against mastitis pathogens in Mueller Hinton broth or serum broth, in normal milk and mastitis milk. MSD Animal Health Study No. 96R/0002.
Study date
1996
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263246
Title
Post antibiotic effects and post antibiotic sub-MIC effects of cephapirin with bovine mastitis pathogens. MSD Animal Health Study No. 95R/0249.
Study date
1995
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263247
Title
Determination of Minimal Inhibitory Concentrations (MICs) of cephapirin against bovine mastitis pathogens isolated in Australia.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263248
Title
Pharmacokinetic and efficacy of a mastitis preparation with 100 mg mecillinam and 100 mg cephapirin (as sodium or benzathine) in cows with experimentally induced Staphylococcus aureus mastitis. MSD Animal Health Study No. 93R/0257.
Study date
1993
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263249
Title
Efficacy of a mastitis preparation with cephapirin and prednisolone in cows with experimental Staphylococcus aureus mastitis: comparison of two treatment regimes versus treatment with Avuloxil. MSD Animal Health Study No. 94R/0085.
Study date
1994
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263250
Title
Efficacy of a mastitis preparation in cows with experimental Staphylococcus aureus mastitis: comparison of two treatment regimes. MSD Animal Health Study 94R/0350.
Study date
1994
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263251
Title
Efficacy of a mastitis preparation in cows with experimental Staphylococcus aureus mastitis: dose finding cephapirin. MSD Animal Health Study No. 95R/0160.
Study date
1995
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263252
Title
Dose effect relationship for cephapirin and bacteriological cure in a Staphylococcus aureus mastitis model; meta-analysis of five dose finding studies. MSD Animal Health Study No. 99R/0365.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263253
Title
Anti-inflammatory action of prednisolone in cows with endotoxin induced mastitis after intramammary infusion of formulation with cephapirin-sodium and prednisolone (dose finding). MSD Animal Health Study No. 94R/0425.
Study date
1994
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263254
Title
Anti-inflammatory action of prednisolone in cows with endotoxin induced mastitis after intramammary infusion of formulation with cephapirin-sodium and different dosages of prednisolone (dose finding). MSD Animal Health Study No. 95R/0111.
Study date
1995
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263255
Title
A comparative field trial of Mastiplan and Synulox for therapy of bovine clinical mastitis. MSD Animal Health Study No. 01R/0285.
Study date
2001
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263256
Title
A comparative field trial of Mastiplan and Peracef for therapy of bovine clinical mastitis. MSD Animal Health Study No. 01R/0542. 07-11-2001.
Study date
2001
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263257
Title
A randomized positive controlled field trial to assess the efficacy and safety of Mastiplan in treatment of bovine clinical mastitis. MSD Animal Health Study No. RE-08910.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263258
Title
Meta analysis of two clinical studies comparing the efficacy of Mastiplan and Synulox. MSD Animal Health Study No. RE-09610.
Study date
2006
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263190
Title
Dose confirmation of prednisolone for treatment of cows with Streptococcus uberis induced mastitis; comparison of treatment with cephapirin alone, with cephapirin and prednisolone and non-treatment. MSD Animal Health Study No. 99R/0505.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263191
Title
Prednisolone and cefapirin act synergistically in resolving experimental Escherichia coli mastitis.
Study date
2013
Auth party contact address
-
Data no
263183
Title
Anti-inflammatory agents in the treatment of mastitis.
Study date
1997
Auth party contact address
-
Data no
263184
Title
Treatment of clinical mastitis in cattle.
Study date
1995
Auth party contact address
-
Data no
263185
Title
Effects of prednisolone on experimentally induced mastitis treated with amoxicillin and clavulanic acid.
Study date
1988
Auth party contact address
-
Data no
263186
Title
Clinical efficacy of prednisolone in cows with experimental Streptococcus uberis mastitis.
Study date
1994
Auth party contact address
-
Data no
263211
Title
Cefalonium Summary Report (2). Committee for veterinary medicinal products.
Study date
2002
Auth party contact address
-
Data no
263212
Title
Cefalexin Summary Report. Committee for veterinary medicinal products.
Study date
1999
Auth party contact address
-
Data no
263219
Title
Prednisolone (as free alcohol) Summary Report. Committee for veterinary medicinal products.
Study date
1999
Auth party contact address
-
Data no
263206
Title
Cefapirin Summary Report (2).
Study date
2001
Auth party contact address
-
Data no
263261
Title
Mastiplan Periodic Safety Update Reports.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263262
Title
MASTIPLAN REGISTRATION FILE: EFFICACY AND SAFETY
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263263
Title
MASTIPLAN DETAILED AND CRITICAL SUMMARY EFFICACY AND SAFETY.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263182
Title
Mastiplan Efficacy and Safety Executive Summary (Part 8).
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263266
Title
Mastiplan Pharmaceutical Development.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263267
Title
Bovine mastitis pathogens and trends in resistance to antibacterial drugs.
Study date
2004
Auth party contact address
-
Data no
263264
Title
Effect of milk fraction on concentrations of cephapirin and desacetylcephapirin in bovine milk after intramammary infusion of cephapirin sodium.
Study date
2009
Auth party contact address
-
Data no
263265
Title
Effect of milking frequency and dosing interval on the pharmacokinetics of cephapirin after intramammary infusion in lactating dairy cows.
Study date
2009
Auth party contact address
-
Data no
263207
Title
Tissue distribution and residues of beta-lactam antibiotics in normal dairy cows.
Study date
1977
Auth party contact address
-
Data no
263208
Title
Pharmacokinetics of sodium cephapirin in lactating dairy cows.
Study date
1988
Auth party contact address
-
Data no
263209
Title
Protein binding of cephapirin in bovine plasma and milk. MSD Animal Health Study No. 91/9120B.
Study date
1991
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263210
Title
Determination and relevance of microbiologically active metabolites of cephapirin. MSD Animal Health Study No. 91/9120A.
Study date
1991
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263242
Title
Active drug metabolites and renal failure.
Study date
1977
Auth party contact address
-
Data no
263243
Title
Cefotaxime, cephalothin, and cefapirin: Antimicrobial activity and synergy studies of cephalosporins with significant in vivo desacetyl metabolite concentrations.
Study date
1984
Auth party contact address
-
Data no
263244
Title
A review of cephalosporin metabolism: a lesson to be learned for future chemotherapy.
Study date
1989
Auth party contact address
-
Data no
263220
Title
Prednisolone metabolism and excretion in the isolated perfused rat kidney.
Study date
1981
Auth party contact address
-
Data no
263221
Title
Metabolism of prednisolone by the isolated perfused human placental lobule.
Study date
1991
Auth party contact address
-
Data no
263222
Title
Effect of liver function on the metabolism of prednisone and prednisolone in humans.
Study date
1986
Auth party contact address
-
Data no
263223
Title
Metabolism of 1-dehydroseroids in man.
Study date
1959
Auth party contact address
-
Data no
263224
Title
Characterization of prednisone, prednisolone and their metabolites by gas chromatography-mass spectrometry.
Study date
1991
Auth party contact address
-
Data no
263225
Title
Simultaneous analysis of prednisone, prednisolone and their major hydroxylated metabolites in urine by high-performance liquid chromatography.
Study date
1991
Auth party contact address
-
Data no
263226
Title
A thin-layer chromatography study on the metabolism of prednisolone in the horse.
Study date
1967
Auth party contact address
-
Data no
263227
Title
Measurements of prednisolone and some of its metabolites, in urine of patients after orthotopic liver transplantation, as a means of monitoring prednisolone absorption.
Study date
1986
Auth party contact address
-
Data no
263228
Title
Biological activity of certain progesterone-like compounds as determined by the Hooker-Forbes bioassay.
Study date
1957
Auth party contact address
-
Data no
263229
Title
Correlation between chemical structure, receptor binding, and biological activity of some novel, highly active, 16a, 17a-acetal-substituted glucocorticoids.
Study date
1984
Auth party contact address
-
Data no
263230
Title
Binding affinities of rimexolone (ORG 6216), flunisolide and their putative metabolites for the glucocorticoid receptor of human synovial tissue.
Study date
1990
Auth party contact address
-
Data no
263231
Title
Oxidation of corticosteroids to steroidal carboxylic acids by an enzyme preparation from hamster liver.
Study date
1977
Auth party contact address
-
Data no
263232
Title
Cephapirin and prednisolone pharmacokinetics in plasma of lactating healthy cows after intramammary treatment containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 99R/0294.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263233
Title
Concentrations of cephapirin in post-milk of cows with Staphylococcus aureus mastitis after intramammary treatment with two formulations containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 98R/0073.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263234
Title
Concentrations of cephapirin in milk and prednisolone in milk and plasma of cows with endotoxin-induced mastitis after
treatment with a mastitis preparation containing cephapirin (as sodium) and prednisolone. MSD Animal Health Study No. 98R/0153.
treatment with a mastitis preparation containing cephapirin (as sodium) and prednisolone. MSD Animal Health Study No. 98R/0153.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263235
Title
Cephapirin and prednisolone pharmacokinetics in plasma of lactating cows with Staphylococcus aureus mastitis
after intramammary treatment containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 99R/0274.
after intramammary treatment containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 99R/0274.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263236
Title
Plasma and milk pharmacokinetic profiles of cephapirin and prednisolone in lactating cows during and after intramammary
treatment with two oily based formulations both containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. RE-05355.
treatment with two oily based formulations both containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. RE-05355.
Study date
2003
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263237
Title
Milk pharmacokinetic profiles of cephapirin, desacetyl-cephapirin and prednisolone after treatment of cows with two different formulations of Mastiplan. MSD Animal Health Study No. RE-08754.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263213
Title
Anti-inflammatory steroid action. Basic and clinical aspects.
Study date
1989
Auth party contact address
-
Data no
263214
Title
Bovine plasma and synovial fluid kinetics of methylprednisolone and methylprednisolone acetate after intra-articular administration of methylprednisolone acetate.
Study date
1986
Auth party contact address
-
Data no
263215
Title
Prednisolone succinate and prednisolone acetate in cattle: pharmacokinetics and action on the adrenal gland.
Study date
1985
Auth party contact address
-
Data no
263216
Title
Dexamethasone and prednisolone in the horse: pharmacokinetics and action on the adrenal gland.
Study date
1984
Auth party contact address
-
Data no
263217
Title
Pharmacokinetics of intravenously administration of prednisolone in the horse as determined by radioimmunoassay.
Study date
1995
Auth party contact address
-
Data no
263218
Title
Metabolism of synthetic steroids.
Study date
1972
Auth party contact address
-
Data no
263187
Title
Effect of steroidal anti-inflammatory drugs on E. coli endotoxin-induced mastitis in the cow.
Study date
1989
Auth party contact address
-
Data no
263188
Title
Effect of intramammary treatment on PMN functions of cows with endotoxin-induced mastitis; comparison of treatment with cefapirin alone, with cefapirin and prednisolone and non-treatment. MSD Animal Health Study No. 98R/0260.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263189
Title
Statistical analysis of the effect of intramammary treatment with prednisolone and cephapirin on polymorphonuclear neutrophil (PMN) functions from blood and milk of cows with lipopolysaccharide induced mastitis. MSD Animal Health Study No.99R/0504.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263192
Title
Aminoglycosides, macrolides, lincosamides, polymyxins, chloramphenicol, and other antibacterial drugs.
Study date
1988
Auth party contact address
-
Data no
263193
Title
Penicillins, cephalosporins, and other B-lactam antibiotics.
Study date
1996
Auth party contact address
-
Data no
263194
Title
Antibacterials. In: The complete drug reference, Martindale
Study date
1999
Auth party contact address
-
Data no
263195
Title
Beta-lactam antibiotics: Penam Penicillins. In: Antimicrobial therapy in Veterinary Medicine. 3rd edition, Prescott : Chapter 6.
Study date
2000
Auth party contact address
-
Data no
263196
Title
Antibiotic treatment for animals: effect on bacterial population and dosage regimen optimisation.
Study date
2000
Auth party contact address
-
Data no
263197
Title
Antimicrobial drug delivery in food animals and microbial food safety concerns: an overview of in vitro and in vivo factors potentially affecting the animal gut microflora.
Study date
2004
Auth party contact address
-
Data no
263198
Title
Study on phagocytosis by polymorphonuclear leucocytes isolated from blood of cows by using flow cytometry: effect of cephapirin and mecillinam. MSD Animal Health Study No. 97R/0367.
Study date
1997
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263199
Title
Study on the respiratory burst activity of polymorphonuclear leucocytes isolated from blood and milk of cows by using chemiluminescence: effect of cephapirin and mecillinam. MSD Animal Health Study No. 97R/0368. 22-08-1997.
Study date
1997
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263200
Title
Regulation of gene expression by glucocorticoids.
Study date
1989
Auth party contact address
-
Data no
263201
Title
Glucocorticoids: Binding Affinity and Lipophilicity.
Study date
1986
Auth party contact address
-
Data no
263202
Title
Prednisolone. In: The complete drug reference, Martindale.
Study date
1999
Auth party contact address
-
Data no
263203
Title
Adrenocorticotropic hormone; adrenocortical steroids and their synthetic analogs; inhibitors of the synthesis and actions of adrenocortical hormones.
Study date
1996
Auth party contact address
-
Data no
263204
Title
Review of the Pharmacology, Pharmacokinetics, and Clinical Use of Cephalosporins.
Study date
1990
Auth party contact address
-
Data no
263205
Title
Comparative pharmacokinetics and metabolism of cephapirin in laboratory animals and human.
Study date
1976
Auth party contact address
-
Data no
263259
Title
Tolerance in dairy cows after intramammary treatment with a formulation containing 300 mg cephapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 99R/0337.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263260
Title
Local tolerance of an intramammary preparation containing 300 mg cephapirin (as sodium) and 20 mg prednisolone in lactating cows. MSD Animal Health Study No. RE-07670.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263004
Title
Environmental Risk Assessment
Study date
2014
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262990
Title
Mastiplan Application Executive Summary
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262992
Title
MASTIPLAN Permit to import
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263108
Title
Mastiplan Worker Health and Safety Data (User Risk Assessment).
Study date
2014
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263122
Title
Prednisolone analysis in biological matrices by HPLC (ISO 78/2) for edible tissues and milk of cattle. MSD Animal Health Study No. 98.090.3.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263128
Title
Validation study of a LC-MS/MS quantification of cephapirin and desacetylcephapirin in bovine milk.MSD Animal Health Study No. 00642-EX.
Study date
2001
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263129
Title
Prednisolone analysis in bovine milk by HPLC and Validation of the determination of prednisolone in bovine milk by HPLC. MSD Animal Health Study Number: 04.209.2
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263130
Title
Prednisolone analysis in bovine tissues by HPLC and Validation of the determination of prednisolone in bovine tissues by HPLC, Study 04.163.2.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263159
Title
Characterization of prednisone, prednisolone and their metabolites by gas chromatography-mass spectrometry.
Study date
1991
Auth party contact address
-
Data no
263160
Title
Simultaneous analysis of prednisone, prednisolone and their major hydroxylated metabolites in urine by high-performance liquid chromatography.
Study date
1991
Auth party contact address
-
Data no
263154
Title
Analysis of prednisone, prednisolone and their 20?-hydroxylated metabolites by high performance liquid chromatography.
Study date
1981
Auth party contact address
-
Data no
263173
Title
Method Validation for Determination of Prednisolone in Kidney and Liver of Cows. Study No. 20863, Report No. 050/93/0022.
Study date
1993
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263174
Title
Addendum to Method Validation for Determination of Prednisolone in Kidney and Liver of Cows. Study No. 20863, Report No. 050/93/0022.
Study date
1993
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263175
Title
Quantitative HPLC analysis of prednisolone in bovine plasma, milk, muscle, fat, and udders. Study Report No. 830/91/0924.
Study date
1991
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263177
Title
The Australian Dairy Industry - In focus 2019
Study date
2019
Auth party contact address
-
Data no
263126
Title
Depletion of cephapirin, desacetyl-cephapirin and prednisolone concentrations in tissues of lactating cows after intramammary treatment with Mastiplan formulation containing 300 mg cephapirin as sodium and 20 mg prednisolone. MSD Animal Health Study No. EX-03136-00, Release No. RE-08673.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263127
Title
Depletion of cephapirin, desacetyl-cephapirin and prednisolone concentrations in milk after treatment of lactating cows with Mastiplan formulation containing 300 mg cephapirin and 20 mg prednisolone. MSD Animal Health Study EX-03312-00.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263133
Title
Cefapirin and prednisolone pharmacokinetics in plasma of lactating healthy cows after intramammary treatment containing 300 mg cefapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 99R/0294.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263134
Title
Plasma and milk pharmacokinetic profiles of cefapirin and prednisolone in lactating cows during and after intramammary treatment with two oily based formulations both containing 300 mg cefapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study Report No. RE-05355.
Study date
2003
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263136
Title
Cefapirin Summary Report (2).
Study date
2001
Auth party contact address
-
Data no
263111
Title
Prednisolone International Maximum Residue Limit Dossier.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263112
Title
Prednisolone MRL Consolidated Response to Committee for Veterinary Medicinal Products (CVMP) Enquiries.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263113
Title
Index of Prednisolone International MRL Dossier.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263114
Title
Prednisolone (as free alcohol) Summary Report.
Study date
1999
Auth party contact address
-
Data no
263115
Title
European public MRL assessment report (EPMAR), Methylprednisolone (bovine milk after provisional MRLs).
Study date
2012
Auth party contact address
-
Data no
263116
Title
Prednisolone Overseas Trade Aspects of Residues in Food Commodities (Part 5B).
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263117
Title
Expert Report on MASTIPLAN Residues Documentation.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263118
Title
Public Release Summary on Evaluation of the new active CEPHAPIRIN in the product Metricure Benzathine cephapirin intra -uterine suspension.
Study date
2001
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263119
Title
Australian Public Assessment Report for Prednisone.
Study date
2013
Auth party contact address
-
Data no
263120
Title
MASTIPLAN Pharmaceutical Development.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263121
Title
Oral liver glycogen test in rats and mice. Intervet International study, Project No. 1/02.02. 1.01.
Study date
1970
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263137
Title
Prednisolone Australian Product Information.
Study date
2021
Auth party contact address
-
Data no
263138
Title
Prednisolone Residues Expert Report.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263139
Title
Metabolism of synthetic corticosteroids in humans.
Study date
1972
Auth party contact address
-
Data no
263140
Title
Isolation and identification of four new carboxylic acid metabolites of cortisol in man.
Study date
1973
Auth party contact address
-
Data no
263141
Title
Prednisolone Toxicity and Pharmacodynamics Expert Reports.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263142
Title
Adrenocorticotropic hormone; adrenocortical steroids and their synthetic analogs; inhibitors of the synthesis and actions of adrenocortical hormones.
Study date
1990
Auth party contact address
-
Data no
263143
Title
Assessment of tyrosine aminotransferase induction in rat liver by prednisolone. MSD Animal Health Study Report No. 93R/0223.
Study date
1994
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263144
Title
Structure-activity relationships in glucocorticoids.
Study date
1979
Auth party contact address
-
Data no
263145
Title
Evaluation of dose-related pharmacokinetics and pharmacodynamics of prednisolone in man.
Study date
1992
Auth party contact address
-
Data no
263146
Title
Human Pharmacokinetic Review; Prednisolone Tablets, Delta-Cortef tablets.
Study date
1986
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263147
Title
Pharmacodynamics of methylprednisolone phosphate after single intravenous administration to healthy volunteers.
Study date
1991
Auth party contact address
-
Data no
263148
Title
Assay of tyrosine transaminase activity by conversion of p-Hydroxyphenylpyruvate to p-Hydroxybenzaldehyde.
Study date
1966
Auth party contact address
-
Data no
263149
Title
Pharmacokinetics and pharmacodynamics of methylprednisolone when administered at 8 am versus 4 pm.
Study date
1992
Auth party contact address
-
Data no
263150
Title
Evaluation of the Teratogenic Potential of Chemicals in the Rat.
Study date
1990
Auth party contact address
-
Data no
263151
Title
Pharmacokinetic-pharmacodynamic modelling of prednisolone induced lymphocytopenia in man.
Study date
1984
Auth party contact address
-
Data no
263152
Title
Prednisolone concentration-effect relations in humans and the influence of plasma hydrocortisone.
Study date
1986
Auth party contact address
-
Data no
263153
Title
Cortisol production rate measured by liquid chromatography / mass spectrometry.
Study date
1990
Auth party contact address
-
Data no
263135
Title
Registration File, MASTIPLAN Residues Documentation.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263131
Title
Mastiplan LC Residues and Trade Scientific Argument.
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263132
Title
Mastiplan Periodic Safety Update Reports.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263123
Title
The relationship between prednisolone and dexamethasone.
Study date
1992
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263124
Title
Biological potencies of chemically modified adrenocorticosteroids in rat and man.
Study date
1964
Auth party contact address
-
Data no
263125
Title
Prednisolone binding to albumin and transcortin in the presence of cortisol.
Study date
1982
Auth party contact address
-
Data no
263109
Title
Mastiplan Residues and Trade Executive Summary.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263110
Title
MASTIPLAN LC ? APVMA Residues and Trade Evaluation Report.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
262991
Title
Mastiplan LC - Residues and Trade Evaluation Report
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263006
Title
Mastiplan LC APVMA Residues and Trade Evaluation Report.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263178
Title
MASTIPLAN Draft E-Label.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263180
Title
APVMA Technical Advice on Residues and Antibiotic Resistance (PAA written assistance).
Study date
2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263155
Title
Prednisolone metabolism and excretion in the isolated perfused rat kidney.
Study date
1981
Auth party contact address
-
Data no
263156
Title
Metabolism of prednisolone by the isolated perfused human placental lobule.
Study date
1991
Auth party contact address
-
Data no
263157
Title
Effect of liver function on the metabolism of prednisone and prednisolone in humans.
Study date
1986
Auth party contact address
-
Data no
263158
Title
Metabolism of 1-Dehydrosteroids in Man.
Study date
1959
Auth party contact address
-
Data no
263161
Title
A thin-layer chromatography study on the metabolism of prednisolone in the horse.
Study date
1967
Auth party contact address
-
Data no
263162
Title
Measurements of prednisolone and some of its metabolites, in urine of patients after orthotopic liver transplantation, as a means of monitoring prednisolone absorption.
Study date
1986
Auth party contact address
-
Data no
263163
Title
Assay of androgens administered by inunction to the chick's comb.
Study date
1963
Auth party contact address
-
Data no
263164
Title
Biological activity of certain progesterone-like compounds as determined by the Hooker-Forbes bioassay.
Study date
1957
Auth party contact address
-
Data no
263165
Title
Correlation between chemical structure, receptor binding, and biological activity of some novel, highly active, 16a, 17a-acetal-substituted glucocorticoids.
Study date
1984
Auth party contact address
-
Data no
263166
Title
Binding affinities of rimexolone (ORG 6216), flunisolide and their putative metabolites for the glucocorticoid receptor of human synovial tissue.
Study date
1990
Auth party contact address
-
Data no
263167
Title
Acidic metabolite of prednisolone.
Study date
1977
Auth party contact address
-
Data no
263168
Title
Serum protein binding of prednisolone in four species.
Study date
1980
Auth party contact address
-
Data no
263169
Title
Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration.
Study date
1992
Auth party contact address
-
Data no
263170
Title
Prednisolone binding to plasma proteins in domestic species
Study date
1988
Auth party contact address
-
Data no
263171
Title
Clinical pharmacokinetics of prednisone and prednisolone.
Study date
1990
Auth party contact address
-
Data no
263172
Title
European public MRL assessment report (EPMAR) Prednisolone (Equidae).
Study date
2013
Auth party contact address
-
Data no
263181
Title
Special Data - Antibiotic Resistance Risk Assessment.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270037
Title
Reverse zoonotic transmission of community-associated MRSA ST1-IV to a dairy cow.
Study date
2017
Auth party contact address
-
Data no
270038
Title
New host shift from human to cows within Staphylococcus aureus involved in bovine mastitis and nasal carriage of animal's caretakers.
Study date
2018
Auth party contact address
-
Data no
270039
Title
Survey and Sequence Characterization of Bovine Mastitis-Associated Escherichia coli in Dairy Herds.
Study date
2020
Auth party contact address
-
Data no
270040
Title
Assessing in vivo and in vitro biofilm development by Streptococcus dysgalactiae subsp. dysgalactiae using a murine model of catheter-associated biofilm and human keratinocyte cell.
Study date
2022
Auth party contact address
-
Data no
270041
Title
Streptococcus dysgalactiae subsp. dysgalactiae isolated from milk of the bovine udder as emerging pathogens: In vitro and in vivo infection of human cells and zebrafish as biological models.
Study date
2019
Auth party contact address
-
Data no
270042
Title
Novel ?-Lactamase bla(ARL) in Staphylococcus arlettae.
Study date
2017
Auth party contact address
-
Data no
270043
Title
Antibiotic resistance risk assessments. Risk assessment for food-producing animals.
Study date
2014
Auth party contact address
-
Data no
270044
Title
Draft Genome Sequences and Antimicrobial Resistance Genes of Five Staphylococcus aureus Strains Isolated from Bovine Milk.
Study date
2022
Auth party contact address
-
Data no
270045
Title
Importance Ratings and Summary of Antibacterial Uses in Human and Animal Health in Australia.
Study date
2018
Auth party contact address
-
Data no
270046
Title
Australia New Zealand Food Standards Code -Standard 4.2.4 - Primary Production and Processing Standard for Dairy Products (Australia Only).
Study date
2021
Auth party contact address
-
Data no
270047
Title
Cephapirin: in vitro antibacterial spectrum.
Study date
1971
Auth party contact address
-
Data no
270048
Title
Phenotypic and Genotypic Assessment of Antimicrobial Resistance in Escherichia coli from Australian Cattle Populations at Slaughter.
Study date
2022
Auth party contact address
-
Data no
270049
Title
Circulation of Streptococcus agalactiae ST103 in a Free Stall Italian Dairy Farm.
Study date
2022
Auth party contact address
-
Data no
270050
Title
Newly identified degradation products of ceftiofur and cephapirin impact the analytical approach for quantitative analysis of kidney.
Study date
2009
Auth party contact address
-
Data no
270051
Title
Performance of ceftriaxone susceptibility testing on the Accelerate Pheno system of ESBL-producing isolates.
Study date
2020
Auth party contact address
-
Data no
270052
Title
In Vitro Susceptibility of Mastitis Pathogens Isolated from Clinical Mastitis Cases on Northern German Dairy Farms.
Study date
2020
Auth party contact address
-
Data no
270053
Title
Comparison of phenotypic and genotypic antimicrobial resistance patterns associated with Staphylococcus aureus mastitis in German and Danish dairy cows.
Study date
2020
Auth party contact address
-
Data no
270054
Title
Bovine Staphylococcus aureus: Subtyping, evolution, and zoonotic transfer.
Study date
2016
Auth party contact address
-
Data no
270055
Title
A Perspective on the Potential Zoonotic Role of Streptococcus agalactiae: Searching for a Missing Link in Alternative Transmission Routes.
Study date
2018
Auth party contact address
-
Data no
270056
Title
Plasma and milk pharmacokinetic profiles of cefapirin and prednisolone in lactating cows during and after intramammary treatment with two oily based formulations both containing 300 mg cefapirin (as sodium) and 20 mg prednisolone.
Study date
2003
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270057
Title
Depletion of cephapirin, desacetyl-cephapirin and prednisolone concentrations in milk after treatment of lactating cows with Mastiplan formulation containing 300 mg cephapirin and 20 mg prednisolone (EX-03312-00, Study report RE-08672).
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270058
Title
Clinical and in vitro evaluation of cephapirin, a new cephalosporin antibiotic.
Study date
1972
Auth party contact address
-
Data no
270059
Title
Mouse mastitis model of infection for antimicrobial compound efficacy studies against intracellular and extracellular forms of Staphylococcus aureus.
Study date
2004
Auth party contact address
-
Data no
270060
Title
Epidemiology of ?-Lactamase-Producing Pathogens.
Study date
2020
Auth party contact address
-
Data no
270061
Title
Comparative pharmacokinetics and metabolism of cephapirin in laboratory animals and humans.
Study date
1976
Auth party contact address
-
Data no
270062
Title
Evidence of Common Isolates of Streptococcus agalactiae in Bovines and Humans in Emilia Romagna Region (Northern Italy).
Study date
2021
Auth party contact address
-
Data no
270063
Title
Extended-spectrum ?-lactamases: an update on their characteristics, epidemiology and detection.
Study date
2021
Auth party contact address
-
Data no
270064
Title
Trace determination of beta-lactam antibiotics in surface water and urban wastewater using liquid chromatography combined with electrospray tandem mass spectrometry.
Study date
2006
Auth party contact address
-
Data no
270065
Title
Estimating the impact of cefuroxime versus cefazolin and amoxicillin/clavulanate use on future collateral resistance: a retrospective comparison.
Study date
2022
Auth party contact address
-
Data no
270066
Title
Bacterial pathogens associated with clinical and subclinical mastitis in a Mediterranean pasture-based dairy production system of Australia.
Study date
2021
Auth party contact address
-
Data no
270067
Title
Dependence of ?-lactamase stability on substructures within ?-lactam antibiotics.
Study date
1984
Auth party contact address
-
Data no
270068
Title
Potential group B Streptococcus interspecies transmission between cattle and people in Colombian dairy farms.
Study date
2019
Auth party contact address
-
Data no
270069
Title
Diseases of the Mammary Gland.
Study date
2017
Auth party contact address
-
Data no
270070
Title
Minimum inhibitory concentrations of cephalosporin compounds and their active metabolites for selected mastitis pathogens.
Study date
2013
Auth party contact address
-
Data no
270071
Title
The fall and rise of group B Streptococcus in dairy cattle: reintroduction due to human-to-cattle host jumps?
Study date
2021
Auth party contact address
-
Data no
270072
Title
Livestock-Associated MRSA: The Impact on Humans.
Study date
2015
Auth party contact address
-
Data no
270073
Title
Cefapirin Summary Report (2).
Study date
2001
Auth party contact address
-
Data no
270074
Title
VICH GL36(R2) Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI - Scientific guideline.
Study date
2019
Auth party contact address
-
Data no
270075
Title
Countdown Farm guidelines for mastitis control.
Study date
2018
Auth party contact address
-
Data no
270076
Title
Monitoring of antimicrobial susceptibility of udder pathogens recovered from cases of clinical mastitis in dairy cows across Europe: VetPath results.
Study date
2018
Auth party contact address
-
Data no
270077
Title
Cephalothin and Cefazolin.
Study date
2018
Auth party contact address
-
Data no
270078
Title
Distribution of serotypes and antimicrobial resistance genes among Streptococcus agalactiae isolates from bovine and human hosts.
Study date
2005
Auth party contact address
-
Data no
270079
Title
Three decades of ?-lactamase inhibitors.
Study date
2010
Auth party contact address
-
Data no
270080
Title
Risk factors for antimicrobial resistance in fecal Escherichia coli from preweaned dairy calves.
Study date
2015
Auth party contact address
-
Data no
270081
Title
A survey of mastitis pathogens including antimicrobial susceptibility in southeastern Australian dairy herds.
Study date
2021
Auth party contact address
-
Data no
270082
Title
Risk for the development of Antimicrobial Resistance (AMR) due to feeding of calves with milk containing residues of antibiotics.
Study date
2017
Auth party contact address
-
Data no
270083
Title
Antimicrobial susceptibility of nine udder pathogens recovered from bovine clinical mastitis milk in Europe 2015?2016: VetPath results.
Study date
2020
Auth party contact address
-
Data no
270084
Title
Mastitis therapy and pharmacology.
Study date
2003
Auth party contact address
-
Data no
270085
Title
A dominant clonal lineage of Streptococcus uberis in cattle in Germany.
Study date
2022
Auth party contact address
-
Data no
270086
Title
Identification and characterization of methicillin-resistant coagulase-negative staphylococci from bovine mastitis.
Study date
2010
Auth party contact address
-
Data no
270087
Title
Characterization of methicillin-resistant Staphylococcus aureus CC398 obtained from humans and animals on dairy farms.
Study date
2012
Auth party contact address
-
Data no
270088
Title
Characterization of methicillin-resistant Staphylococcus aureus ST398 from cases of bovine mastitis.
Study date
2010
Auth party contact address
-
Data no
270089
Title
Proposal P296 - Primary Production & Processing Standard for Dairy. Final Assessment Report.
Study date
2006
Auth party contact address
-
Data no
270090
Title
Proposal P296 - Primary Production & Processing Standard for Dairy. Final Assessment Report. Attachment 2. A Risk Profile of Dairy Products in Australia.
Study date
2006
Auth party contact address
-
Data no
270091
Title
Meticillin-resistant Staphylococcus aureus with a novel mecA homologue in human and bovine populations in the UK and Denmark: a descriptive study.
Study date
2011
Auth party contact address
-
Data no
270092
Title
An overview of factors affecting the disposition of intramammary preparations used to treat bovine mastitis.
Study date
2006
Auth party contact address
-
Data no
270093
Title
Phenotypic and Genotypic Characterization of Antimicrobial Resistance in Streptococci Isolated from Human and Animal Clinical Specimens.
Study date
2023
Auth party contact address
-
Data no
270094
Title
Pharmacological Basis of Therapeutics.
Study date
1975
Auth party contact address
-
Data no
270095
Title
Elimination kinetics of cephapirin sodium in milk after an 8-day extended therapy program of daily intramammary infusion in healthy lactating Holstein-Friesian cows.
Study date
2013
Auth party contact address
-
Data no
270096
Title
Escherichia coli Mastitis in Dairy Cattle: Etiology, Diagnosis, and Treatment Challenges.
Study date
2022
Auth party contact address
-
Data no
270097
Title
In vitro activity of 10 antimicrobial agents against bacteria isolated from cows with clinical mastitis.
Study date
2003
Auth party contact address
-
Data no
270098
Title
Cephalosporin antimicrobial agents and related compounds.
Study date
1991
Auth party contact address
-
Data no
270099
Title
Antimicrobial Resistance in Streptococcus spp.
Study date
2018
Auth party contact address
-
Data no
270100
Title
Economic effects of bovine mastitis and mastitis management: a review.
Study date
2007
Auth party contact address
-
Data no
270101
Title
A Staphylococcus xylosus isolate with a new mecC allotype.
Study date
2013
Auth party contact address
-
Data no
270102
Title
Comparison of phenotypic and genotypic detection of penicillin G resistance of Staphylococcus aureus isolated from bovine intramammary infection.
Study date
2005
Auth party contact address
-
Data no
270103
Title
Methicillin resistant S. aureus in human and bovine mastitis.
Study date
2011
Auth party contact address
-
Data no
270104
Title
Cefotaxime, cephalothin, and cephapirin: antimicrobial activity and synergy studies of cephalosporins with significant in vivo desacetyl metabolite concentrations.
Study date
1984
Auth party contact address
-
Data no
270105
Title
MRSA transmission between cows and humans.
Study date
2007
Auth party contact address
-
Data no
270106
Title
Comparative analysis of genetic characterization of ?-lactam-resistant Escherichia coli from bulk tank milk in Korea.
Study date
2021
Auth party contact address
-
Data no
270107
Title
The Role of Streptococcus spp. in Bovine Mastitis.
Study date
2021
Auth party contact address
-
Data no
270108
Title
Changes in antimicrobial resistance of Staphylococcus aureus in bovine quarter milk samples from Southern Germany between 2012 and 2022.
Study date
2023
Auth party contact address
-
Data no
270109
Title
Genomic characterization of coagulase-negative staphylococci including methicillin-resistant Staphylococcus sciuri causing bovine mastitis.
Study date
2018
Auth party contact address
-
Data no
270110
Title
Comparison of the in vitro activity of several cephalosporin antibiotics against gram-negative and gram-positive bacteria resistant to cephaloridine.
Study date
1976
Auth party contact address
-
Data no
270111
Title
MRSA harboring mecA variant gene mecC, France.
Study date
2012
Auth party contact address
-
Data no
270112
Title
Use of a heavy inoculum in the in vitro evaluation of the anti-staphylococcal activity of 19 cephalosporins.
Study date
1978
Auth party contact address
-
Data no
270113
Title
Overview of MIC'S of cephapirin against bovine mastitis pathogens isolated from 1984 to 1999 in Europe. MSD Animal Health Study No. 00111-RE.
Study date
2000
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270114
Title
Milk pharmacokinetic profiles of cephapirin, desacetyl-cephapirin and prednisolone after treatment of cows with two different formulations of Mastiplan. MSD Animal Health StudyNo. RE-08754.
Study date
2005
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270115
Title
The pathogenic potential and genetic attributes of Escherichia coli in milk from dairy cows with subclinical mastitis.
Study date
2022
Auth party contact address
-
Data no
270116
Title
Genomic Distinctions of LA-MRSA ST398 on Dairy Farms From Different German Federal States With a Low Risk of Severe Human Infections.
Study date
2020
Auth party contact address
-
Data no
270117
Title
?-lactam antibiotics: An overview from a medicinal chemistry perspective.
Study date
2020
Auth party contact address
-
Data no
270118
Title
Characteristics of Escherichia coli Isolated from Bovine Mastitis Exposed to Subminimum Inhibitory Concentrations of Cefalotin or Ceftazidime.
Study date
2018
Auth party contact address
-
Data no
270119
Title
Susceptibility of anaerobic and aerobic isolates from human faeces towards cephapirin (high inoculum). MSD Animal Health Study number 96/21066, Release number 97R/0195.
Study date
1997
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270120
Title
Susceptibility of anaerobic and aerobic isolates from human faeces towards desacetyl-cephapirin (high inoculum). MSD Animal Health Study number 97/21063A, Release number 98R/0040.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270121
Title
Streptococcus agalactiae Serotype IV in Humans and Cattle, Northern Europe(1).
Study date
2016
Auth party contact address
-
Data no
270122
Title
Genomic and phenotypic profiling of Staphylococcus aureus isolates from bovine mastitis for antibiotic resistance and intestinal infectivity.
Study date
2023
Auth party contact address
-
Data no
270123
Title
The cephalosporins.
Study date
1999
Auth party contact address
-
Data no
270124
Title
Characterization of Streptococcus agalactiae isolates of bovine and human origin by randomly amplified polymorphic DNA analysis.
Study date
2000
Auth party contact address
-
Data no
270125
Title
Evaluating the solubility of compounds intended for intramammary infusion based upon tests conducted across a range of milk matrices.
Study date
2023
Auth party contact address
-
Data no
270126
Title
Characterization of Staphylococcus aureus isolates from raw milk sources in Victoria, Australia.
Study date
2016
Auth party contact address
-
Data no
270127
Title
Epidemiology of Antimicrobial Resistance Genes in Streptococcus agalactiae Sequences from a Public Database in a One Health Perspective.
Study date
2022
Auth party contact address
-
Data no
270128
Title
Phylogenetic Analysis of Escherichia coli Isolated from Australian Feedlot Cattle in Comparison to Pig Faecal and Poultry/Human Extraintestinal Isolates.
Study date
2023
Auth party contact address
-
Data no
270129
Title
Phenotypic and Genotypic Analysis of Antimicrobial Resistance in Escherichia coli Recovered from Feedlot Beef Cattle in Australia.
Study date
2022
Auth party contact address
-
Data no
270130
Title
Conversion of cephapirin to deacetylcephapirin in milk and tissues of treated animals.
Study date
2000
Auth party contact address
-
Data no
270131
Title
Microarray based study on virulence-associated genes and resistance determinants of Staphylococcus aureus isolates from cattle.
Study date
2007
Auth party contact address
-
Data no
270132
Title
Different distribution of antimicrobial resistance genes and virulence profiles of Staphylococcus aureus strains isolated from clinical mastitis in six countries.
Study date
2020
Auth party contact address
-
Data no
270133
Title
Genotyping and Antimicrobial Susceptibility Profiling of Streptococcus uberis Isolated from a Clinical Bovine Mastitis Outbreak in a Dairy Farm.
Study date
2021
Auth party contact address
-
Data no
270134
Title
Bovine mastitis, a worldwide impact disease: Prevalence, antimicrobial resistance, and viable alternative approaches.
Study date
2023
Auth party contact address
-
Data no
270135
Title
Genomic Analysis of Bovine Staphylococcus aureus Isolates from Milk To Elucidate Diversity and Determine the Distributions of Antimicrobial and Virulence Genes and Their Association with Mastitis.
Study date
2020
Auth party contact address
-
Data no
270136
Title
Antimicrobial resistance in non-aureus staphylococci isolated from milk is associated with systemic but not intramammary administration of antimicrobials in dairy cattle.
Study date
2018
Auth party contact address
-
Data no
270137
Title
Prevalence and Genetic Basis of Antimicrobial Resistance in Non-aureus Staphylococci Isolated from Canadian Dairy Herds.
Study date
2018
Auth party contact address
-
Data no
270138
Title
Public Release Summary on Evaluation of the new active CEPHAPIRIN in the product/s Metricure Benzathine cephapirin intra -uterine suspension.
Study date
2001
Auth party contact address
-
Data no
270139
Title
Annual Report 2021?22, Dairy.
Study date
2022
Auth party contact address
-
Data no
270140
Title
Structure-activity relations and beta-lactamase resistance.
Study date
1980
Auth party contact address
-
Data no
270141
Title
Antimicrobial resistance and genomic insights into bovine mastitis-associated Staphylococcus aureus in Australia.
Study date
2020
Auth party contact address
-
Data no
270142
Title
Diversity and evolution of blaZ from Staphylococcus aureus and coagulase-negative staphylococci.
Study date
2006
Auth party contact address
-
Data no
270143
Title
Effect of selected antibiotics on Staphylococcus aureus present in milk from infected mammary glands.
Study date
1993
Auth party contact address
-
Data no
270144
Title
The postantibiotic effect of selected antibiotics on Staphylococcus aureus Newbould 305 from bovine intramammary infection.
Study date
1993
Auth party contact address
-
Data no
270145
Title
Structural and Mechanistic Basis for Extended-Spectrum Drug-Resistance Mutations in Altering the Specificity of TEM, CTX-M, and KPC ?-lactamases.
Study date
2018
Auth party contact address
-
Data no
270146
Title
Comparative genomic analysis of Staphylococcus aureus isolates associated with either bovine intramammary infections or human infections demonstrates the importance of restriction-modification systems in host adaptation.
Study date
2022
Auth party contact address
-
Data no
270147
Title
Postantibiotic effects and postantibiotic-sub-MIC effects of cephapirin with bovine mastitis pathogens. MSD Animal Health Study No. 95R/0249.
Study date
1995
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270148
Title
Risk factors associated with short-term post-treatment outcomes of clinical mastitis.
Study date
2011
Auth party contact address
-
Data no
270149
Title
Antimicrobial Resistance in Escherichia coli.
Study date
2018
Auth party contact address
-
Data no
270150
Title
Beta-lactam Antibiotics: Cephalosporins.
Study date
2013
Auth party contact address
-
Data no
270151
Title
Letter to the editor: The claimed synergistic action of prednisolone and cefapirin in mastitis therapy: a comment on Sipka et al. (2013).
Study date
2014
Auth party contact address
-
Data no
270152
Title
Cephalosporin antibiotics in the aquatic environment: A critical review of occurrence, fate, ecotoxicity and removal technologies.
Study date
2018
Auth party contact address
-
Data no
270153
Title
Effect of heat treatments on stability of ?-lactams in milk.
Study date
2011
Auth party contact address
-
Data no
270154
Title
Comparative genomics study of Staphylococcus aureus isolated from cattle and humans reveals virulence patterns exclusively associated with bovine clinical mastitis strains.
Study date
2022
Auth party contact address
-
Data no
270155
Title
Antimicrobial Resistance Profiles of Staphylococcus Isolated from Cows with Subclinical Mastitis: Do Strains from the Environment and from Humans Contribute to the Dissemination of Resistance among Bacteria on Dairy Farms in Colombia?
Study date
2023
Auth party contact address
-
Data no
270156
Title
Low prevalence of antimicrobial resistant organisms (methicillin resistant Staphylococcus aureus, extended beta-lactamase producing Enterobacteriaceae, and vancomycin resistant enterococci) in bulk tank milk in New South Wales, Australia.
Study date
2023
Auth party contact address
-
Data no
270157
Title
EFFECT OF INOCULUM AND OF BETA-LACTAMASE ON ANTI-STAPHYLOCOCCAL ACTIVITY OF 13 PENICILLINS AND CEPHALOSPORINS.
Study date
1975
Auth party contact address
-
Data no
270158
Title
Minimum inhibitory concentrations for selected antimicrobial agents against organisms isolated from the mammary glands of dairy heifers in New Zealand and Denmark.
Study date
1998
Auth party contact address
-
Data no
270159
Title
Antimicrobial susceptibility of coagulase-negative Staphylococcus species isolated from bovine milk.
Study date
2009
Auth party contact address
-
Data no
270160
Title
Diversity of methicillin-resistant Staphylococcus aureus (MRSA) isolated from Austrian ruminants and New World camelids.
Study date
2018
Auth party contact address
-
Data no
270161
Title
Molecular Characterization of Staphylococcus aureus Isolated from Bovine Mastitis and Close Human Contacts in South African Dairy Herds: Genetic Diversity and Inter-Species Host Transmission.
Study date
2017
Auth party contact address
-
Data no
270162
Title
Risk Factors for the Occurrence of Methicillin-Resistant Staphylococcus aureus in Dairy Herds: An Update.
Study date
2020
Auth party contact address
-
Data no
270163
Title
Antimicrobial Resistance among Staphylococci of Animal Origin.
Study date
2018
Auth party contact address
-
Data no
270164
Title
Antimicrobial Resistance and Clonal Lineages of Staphylococcus aureus from Cattle, Their Handlers, and Their Surroundings: A Cross-Sectional Study from the One Health Perspective.
Study date
2022
Auth party contact address
-
Data no
270165
Title
Unusual finding of the human-adapted hypervirulent serotype III/ST17 clone in a historical bovine Group B Streptococcus isolate from Brazil.
Study date
2021
Auth party contact address
-
Data no
270166
Title
Prednisolone and cefapirin act synergistically in resolving experimental Escherichia coli mastitis.
Study date
2013
Auth party contact address
-
Data no
270167
Title
Impact of intramammary treatment on gene expression profiles in bovine Escherichia coli mastitis.
Study date
2014
Auth party contact address
-
Data no
270168
Title
The distribution of clones of Streptococcus agalactiae (group B streptococci) among herdspersons and dairy cows demonstrates lack of host specificity for some lineages.
Study date
2019
Auth party contact address
-
Data no
270169
Title
Methicillin-resistant Staphylococcus aureus (MRSA) in three dairy herds in southwest Germany.
Study date
2011
Auth party contact address
-
Data no
270170
Title
Effect of milking frequency and dosing interval on the pharmacokinetics of cephapirin after intramammary infusion in lactating dairy cows.
Study date
2009
Auth party contact address
-
Data no
270171
Title
Effect of milk fraction on concentrations of cephapirin and desacetylcephapirin in bovine milk after intramammary infusion of cephapirin sodium.
Study date
2009
Auth party contact address
-
Data no
270172
Title
Antimicrobial susceptibility monitoring of mastitis pathogens isolated from acute cases of clinical mastitis in dairy cows across Europe: VetPath results.
Study date
2015
Auth party contact address
-
Data no
270173
Title
Antimicrobial use on Australian dairy cattle farms - A survey of veterinarians.
Study date
2022
Auth party contact address
-
Data no
270174
Title
Methicillin and aminoglycoside resistance in Staphylococcus aureus isolates from bovine mastitis and sequence analysis of their mecA genes.
Study date
2009
Auth party contact address
-
Data no
270175
Title
Methicillin-resistant staphylococci isolated from animals.
Study date
2004
Auth party contact address
-
Data no
270176
Title
Characterization of methicillin-resistant non-Staphylococcus aureus staphylococci carriage isolates from different bovine populations.
Study date
2013
Auth party contact address
-
Data no
270177
Title
Methicillin-resistant Staphylococcus aureus (MRSA) ST398 associated with clinical and subclinical mastitis in Belgian cows.
Study date
2010
Auth party contact address
-
Data no
270178
Title
Occurrence of the blaZ gene in penicillin resistant Staphylococcus aureus isolated from bovine mastitis in Denmark.
Study date
1999
Auth party contact address
-
Data no
270179
Title
Methicillin-resistant Staphylococcus aureus ST9 from a case of bovine mastitis carries the genes cfr and erm(A) on a small plasmid.
Study date
2012
Auth party contact address
-
Data no
270180
Title
Susceptibility to cephalosporins of bacteria causing intramammary infections in dairy cows with a high somatic cell count in Germany.
Study date
2016
Auth party contact address
-
Data no
270181
Title
Bacteremia associated with naturally occuring acute coliform mastitis in dairy cows.
Study date
2001
Auth party contact address
-
Data no
270182
Title
AWaRe classification of antibiotics for evaluation and monitoring of use, 2023.
Study date
2023
Auth party contact address
-
Data no
270183
Title
Evaluation of a new cephalosporin antibiotic, cephapirin.
Study date
1972
Auth party contact address
-
Data no
270184
Title
The new macrolide-lincosamide-streptogramin B resistance gene erm(45) is located within a genomic island in Staphylococcus fleurettii.
Study date
2015
Auth party contact address
-
Data no
270185
Title
Molecular Characterization of Methicillin-Resistant Staphylococcus aureus Isolated from Australian Animals and Veterinarians.
Study date
2018
Auth party contact address
-
Data no
270186
Title
Comparison of genes involved in penicillin resistance in staphylococci of bovine origin.
Study date
2000
Auth party contact address
-
Data no
270187
Title
Diversity of staphylococcal cassette chromosome in coagulase-negative staphylococci from animal sources.
Study date
2009
Auth party contact address
-
Data no
270188
Title
Determination of Minimal Inhibitory Concentrations (MICs) of cephapirin against bovine mastitis pathogens isolated in Australia.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270189
Title
MASTIPLAN L.C. BROAD SPECTRUM LACTATING COW TREATMENT - Special Data ? Antibiotic Resistance Risk Assessment - REFERENCES LIST
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
270190
Title
Relative morphological effects induced by cefoxitin and other beta-lactam antibiotics in vitro.
Study date
1976
Auth party contact address
-
Data no
270191
Title
Activity of four cephalosporinan antibiotics in vitro against bovine udder pathogens and pathogenic bacteria isolated from newborn calves.
Study date
1976
Auth party contact address
-
Data no
263036
Title
Repeated dose toxicity of prednisolone.
Study date
1961
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263077
Title
S.S. Delta-Cortef hemisuccinate - intramuscular irritation in rabbits
Study date
1955
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263078
Title
Solu-Delta-Cortef 100 mg with Triton - intramuscular irritation in rabbits.
Study date
1957
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263045
Title
Sister chromatid exchanges in human lymphocytes treated with combinations of cytotoxic drugs.
Study date
1982
Auth party contact address
-
Data no
263046
Title
Comparative teratogenicity of selected glucocorticoids applied ocularly in mice.
Study date
1977
Auth party contact address
-
Data no
263038
Title
Effect of L-glutamic acid on glucocorticoid-induced cleft palate in gestating albino mice.
Study date
1980
Auth party contact address
-
Data no
263039
Title
Deleterious effects of prenatal prednisolone exposure upon morphological and behavioral development of mice.
Study date
1981
Auth party contact address
-
Data no
263040
Title
Brief prenatal exposure to prednisolone adversely affects behavioral development and body weight.
Study date
1982
Auth party contact address
-
Data no
263041
Title
Induction of cleft palate in rats with anti-inflammatory drugs.
Study date
1971
Auth party contact address
-
Data no
263042
Title
Induction of celft palate in rabbits by several glucocorticoids.
Study date
1967
Auth party contact address
-
Data no
263043
Title
Cleft palate induction in hamster fetuses by glucocorticoid hormones and their synthetic analogues.
Study date
1976
Auth party contact address
-
Data no
263072
Title
Palatal Slit and Cleft Palate in Rats Treated with Glucocorticoids II. Comparative Teratogenicity of Prednisolone, Triamcinolone Acetonide and Hydrocortisone.
Study date
1995
Auth party contact address
-
Data no
263073
Title
Evaluation of the Teratogenic Potential of Chemicals in the Rat.
Study date
1990
Auth party contact address
-
Data no
263176
Title
Palatal Slit and Cleft Palate in Rats Treated with Glucocorticoids II. Comparative Teratogenicity of Prednisolone, Triamcinolone Acetonide and Hydrocortisone.
Study date
1995
Auth party contact address
-
Data no
263053
Title
Regulation of gene expression by glucocorticoids.
Study date
1989
Auth party contact address
-
Data no
263047
Title
Evaluation of a genotoxicity test measuring DNA-strand breaks in mouse lymphoma cells by alkaline unwinding and hydroxyapatite elution.
Study date
1988
Auth party contact address
-
Data no
263048
Title
Mouse lymphoma L5178Y thymidine kinase locus assay of 50 compounds.
Study date
1988
Auth party contact address
-
Data no
263037
Title
Hormones Influencing Metabolism.
Study date
1988
Auth party contact address
-
Data no
263074
Title
Oral liver glycogen test in rats and mice. Intervet International, Project No. 1/02.02. 1.01.
Study date
1970
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263057
Title
Prednisolone metabolism and excretion in the isolated perfused rat kidney.
Study date
1981
Auth party contact address
-
Data no
263058
Title
Metabolism of prednisolone by the isolated perfused human placental lobule.
Study date
1991
Auth party contact address
-
Data no
263059
Title
Effect of liver function on the metabolism of prednisone and prednisolone in humans.
Study date
1986
Auth party contact address
-
Data no
263060
Title
Metabolism of 1-Dehydrosteroids in Man.
Study date
1959
Auth party contact address
-
Data no
263061
Title
Characterization of prednisone, prednisolone and their metabolites by gas chromatography-mass spectrometry.
Study date
1991
Auth party contact address
-
Data no
263062
Title
Simultaneous analysis of prednisone, prednisolone and their major hydroxylated metabolites in urine by high-performance liquid chromatography.
Study date
1991
Auth party contact address
-
Data no
263063
Title
A thin-layer chromatography study on the metabolism of prednisolone in the horse.
Study date
1967
Auth party contact address
-
Data no
263064
Title
Metabolism of synthetic corticosteroids in humans.
Study date
1972
Auth party contact address
-
Data no
263065
Title
Measurements of prednisolone and some of its metabolites, in urine of patients after orthotopic liver transplantation, as a means of monitoring prednisolone absorption.
Study date
1986
Auth party contact address
-
Data no
263066
Title
Biological activity of certain progesterone-like compounds as determined by the Hooker-Forbes bioassay.
Study date
1957
Auth party contact address
-
Data no
263067
Title
Correlation between chemical structure, receptor binding, and biological activity of some novel, highly active, 16a, 17a-acetal-substituted glucocorticoids.
Study date
1984
Auth party contact address
-
Data no
263068
Title
Binding affinities of rimexolone (ORG 6216), flunisolide and their putative metabolites for the glucocorticoid receptor of human synovial tissue.
Study date
1990
Auth party contact address
-
Data no
263032
Title
Assessment of tyrosine aminotransferase induction in rat liver by prednisolone. MSD Animal Health Study Report No. 93R/0223.
Study date
1994
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263086
Title
Assay of tyrosine transaminase activity by conversion of p-Hydroxyphenylpyruvate to p-Hydroxybenzaldehyde.
Study date
1966
Auth party contact address
-
Data no
263087
Title
Assay of androgens administered by inunction to the chick's comb.
Study date
1963
Auth party contact address
-
Data no
263083
Title
Effect of dexamethasone on tyrosine aminotransferase activity in rat liver - a sensitive test to define its hormonal no-effect level.
Study date
1991
Auth party contact address
-
Data no
263084
Title
Isolation and identification of four new carboxylic acid metabolites of cortisol in man.
Study date
1973
Auth party contact address
-
Data no
263092
Title
Cycloheximide causes increased accumulation of translatable mRNA for tyrosine aminotransferase and tryptophan oxygenase in livers of cortisol-treated rats.
Study date
1978
Auth party contact address
-
Data no
263096
Title
Acidic metabolite of prednisolone.
Study date
1977
Auth party contact address
-
Data no
263100
Title
Biological potencies of chemically modified adrenocorticosteroids in rat and man.
Study date
1964
Auth party contact address
-
Data no
263101
Title
Analysis of prednisone, prednisolone and their 20?-hydroxylated metabolites by high performance liquid chromatography.
Study date
1981
Auth party contact address
-
Data no
263102
Title
Initial steps in the induction by glucocorticosteroids of rat liver tryptophan oxygenase and tyrosine aminotransferase.
Study date
1978
Auth party contact address
-
Data no
263104
Title
Down-regulation of glucocorticoid receptor and its relationship to the induction of rat liver tyrosine aminotransferase.
Study date
1989
Auth party contact address
-
Data no
263094
Title
Dynamics of glucocorticoid receptor and induction of tyrosine aminotransferase in rat liver.
Study date
1982
Auth party contact address
-
Data no
263095
Title
Consideration of Proposed Draft Maximum Residue Limits for Veterinary Drugs. Summary and Conclusions. Draft section from the report of the forty second meeting of JECFA.
Study date
1994
Auth party contact address
-
Data no
263105
Title
Mastiplan Periodic Safety Update Reports.
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263106
Title
Prednisolone Australian Product Information.
Study date
2021
Auth party contact address
-
Data no
263107
Title
Cefapirin and prednisolone pharmacokinetics in plasma of lactating healthy cows after intramammary treatment containing 300 mg cefapirin (as sodium) and 20 mg prednisolone. MSD Animal Health Study No. 99R/0294.
Study date
1999
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263103
Title
Review of glucocorticoid pharmacology.
Study date
1982
Auth party contact address
-
Data no
263097
Title
Prednisolone In: Martindale - The Extra Pharmacopoeia
Study date
1993
Auth party contact address
-
Data no
263098
Title
Pharmacokinetic-pharmacodynamic modelling of prednisolone induced lymphocytopenia in man.
Study date
1984
Auth party contact address
-
Data no
263099
Title
Prednisolone concentration-effect relations in humans and the influence of plasma hydrocortisone.
Study date
1986
Auth party contact address
-
Data no
263093
Title
Kinetics of pharmacologic response.
Study date
1982
Auth party contact address
-
Data no
263085
Title
Pharmacodynamics of methylprednisolone phosphate after single intravenous administration to healthy volunteers.
Study date
1991
Auth party contact address
-
Data no
263088
Title
Cortisol production rate measured by liquid chromatography / mass spectrometry.
Study date
1990
Auth party contact address
-
Data no
263089
Title
Pharmacokinetics and pharmacodynamics of methylprednisolone when administered at 8 am versus 4 pm.
Study date
1992
Auth party contact address
-
Data no
263090
Title
Realistic guidelines of corticosteroid therapy in rheumatic disease.
Study date
1981
Auth party contact address
-
Data no
263091
Title
Adrenocorticotropic hormone; adrenocortical steroids and their synthetic analogs; inhibitors of the synthesis and actions of adrenocortical hormones.
Study date
1990
Auth party contact address
-
Data no
263079
Title
Comparison of the biopotency of corticosterone and dexamethasone acetate in glucocorticoid receptor down regulation in rat liver.
Study date
1989
Auth party contact address
-
Data no
263080
Title
Stress-Induced changes of glucocorticoid receptor in rat liver.
Study date
1992
Auth party contact address
-
Data no
263081
Title
General presence of glucocorticoid receptors in mammalian tissues.
Study date
1974
Auth party contact address
-
Data no
263082
Title
Medical Progress; Hormone Receptors.
Study date
1979
Auth party contact address
-
Data no
263005
Title
Mastiplan Toxicology and Occupational Health and Safety Executive Summary (Health Module).
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263007
Title
Prednisolone International Maximum Residue Limit Dossier.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263008
Title
Prednisolone MRL Consolidated Response to Committee for Veterinary Medicinal Products (CVMP) Enquiries.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263009
Title
Index of Prednisolone International MRL Dossier
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263010
Title
Prednisolone (as free alcohol) Summary Report.
Study date
July 1999
Auth party contact address
-
Data no
263011
Title
Registration File - Prednisolone Toxicology and User Safety Documentation
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263012
Title
Mastiplan Pharmaceutical Development.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263013
Title
Expert Report on MASTIPLAN Toxicity and User Safety.
Study date
2008
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263014
Title
Prednisolone
Study date
1999
Auth party contact address
-
Data no
263015
Title
Adrenocorticotropic hormone; adrenocortical steroids and their synthetic analogs; inhibitors of the synthesis and actions of adrenocortical hormones.
Study date
1996
Auth party contact address
-
Data no
263016
Title
Australian Public Assessment Report for Prednisone.
Study date
2013
Auth party contact address
-
Data no
263017
Title
Dexamethasone (Extrapolation to goats) Summary Report (3).
Study date
2004
Auth party contact address
-
Data no
263018
Title
Bovine plasma and synovial fluid kinetics of methylprednisolone and methylprednisolone acetate after intra-articular administration of methylprednisolone acetate.
Study date
1986
Auth party contact address
-
Data no
263019
Title
Prednisolone succinate and prednisolone acetate in cattle: pharmacokinetics and action on the adrenal gland.
Study date
1985
Auth party contact address
-
Data no
263020
Title
Dexamethasone and prednisolone in the horse: pharmacokinetics and action on the adrenal gland
Study date
1984
Auth party contact address
-
Data no
263021
Title
Pharmacokinetics of intravenously administration of prednisolone in the horse as determined by radioimmunoassay.
Study date
1995
Auth party contact address
-
Data no
263022
Title
Prednisolone binding to plasma proteins in domestic species
Study date
1988
Auth party contact address
-
Data no
263023
Title
Prednisolone binding to albumin and transcortin in the presence of cortisol.
Study date
1982
Auth party contact address
-
Data no
263024
Title
Serum protein binding of prednisolone in four species.
Study date
1980
Auth party contact address
-
Data no
263025
Title
Clinical pharmacokinetics of prednisone and prednisolone.
Study date
1990
Auth party contact address
-
Data no
263026
Title
Oxidation of corticosteroids to steroidal carboxylic acids by an enzyme preparation from hamster liver.
Study date
1977
Auth party contact address
-
Data no
263027
Title
The risks of systemic corticosteroid use.
Study date
1998
Auth party contact address
-
Data no
263069
Title
Evaluation of dose-related pharmacokinetics and pharmacodynamics of prednisolone in man.
Study date
1992
Auth party contact address
-
Data no
263075
Title
The relationship between prednisolone and dexamethasone.
Study date
1992
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263076
Title
Human Pharmacokinetic Review; Prednisolone Tablets, Delta-Cortef tablets.
Study date
1986
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263054
Title
Glucocorticoids: Binding Affinity and Lipophilicity.
Study date
1986
Auth party contact address
-
Data no
263055
Title
Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration.
Study date
1992
Auth party contact address
-
Data no
263056
Title
Corticosteroids and Growth.
Study date
1976
Auth party contact address
-
Data no
263029
Title
Clinical pharmacokinetics of prednisone and prednisolone.
Study date
1979
Auth party contact address
-
Data no
263030
Title
Corticosteroids: a review with emphasis on complications of prolonged systemic therapy.
Study date
1989
Auth party contact address
-
Data no
263031
Title
Mastiplan Toxicology Scientific Argument.
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263049
Title
Prednisolone Toxicity and Pharmacodynamics Expert Reports.
Study date
1998
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263050
Title
Prednisolone and Dexamethasone: minimum inhibitory concentration determinations against representative bacterial species.
Study date
1994
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263051
Title
METRICURE APVMA Toxicology Evaluation Report.
Study date
1997
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263052
Title
Structure-activity relationships in glucocorticoids.
Study date
1979
Auth party contact address
-
Data no
263179
Title
MASTIPLAN Draft E - Label
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263044
Title
Investigation into the effects of prednisolone on the development of foetal abnormalities and induction of abortion in dairy cattle following treatment for mastitis.
Study date
1989
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263070
Title
Reproductive and developmental toxicity study of Prednisolone farnesylate (PNF). Study by Subcutaneous Administration of PNF Prior to and in the Early Stages of Pregnancy in Rats.
Study date
1992
Auth party contact address
-
Data no
263071
Title
Reproductive and developmental toxicity study of Prednisolone farnesylate (PNF). Study by Subcutaneous Administration of PNF During the Period of Fetal Organogenesis in Rats.
Study date
1992
Auth party contact address
-
Data no
263028
Title
Acute toxicity of corticoids in the mouse.
Study date
1966
Auth party contact address
-
Data no
263033
Title
Acute toxicity of corticosteroids in the rat.
Study date
1966
Auth party contact address
-
Data no
263034
Title
Single dose toxicity of prednisolone.
Study date
1963
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
263035
Title
A study of the subacute toxicity of prednisolone, methylprednisolone, and triamcinolone in dogs.
Study date
1959
Auth party contact address
-
Date
Application Date
Application No
Application Number
142377
Product/Active constituent Name
Application Product Name
MAVRIK AQUAFLOW INSECTICIDE
Application Date
Application Number
142377
Application Product Name
MAVRIK AQUAFLOW INSECTICIDE
Application details
Product name:
MAVRIK AQUAFLOW INSECTICIDE
Product number:
54223
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to add new uses in avocado, mango and macadamia; extend uses to all states, correct the formulation type and register a pack size range.
Active constituents:
Active constituent name
44046 - TAU-FLUVALINATE
Description of data provided:
Data no
272515
Title
Efficacy of Insecticides on lace bug in macadamias.
Study date
October 2019
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272516
Title
Evaluate crop safety and efficacy of Mavrik Aquaflow for control of lace bug in macadamia.
Study date
October 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272517
Title
Efficacy of Mavrik on thrips in avocado
Study date
March 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272518
Title
Evaluate crop safety and efficacy of Mavrik Aquaflow for control of Lace bug in macadamia.
Study date
October 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272519
Title
Evaluate crop safety and efficacy of Mavrik Aqualflow for contron of Lace bug in Macadamia.
Study date
October 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272520
Title
Efficacy of Mavrik on thrips in avocado.
Study date
March 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272521
Title
Efficacy of Mavrik on thrips in avocado.
Study date
March 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272522
Title
Efficacy of Mavrik on thrips in mango.
Study date
February 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272523
Title
Efficacy on Mavrik on thrips in mango.
Study date
February 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
272524
Title
Efficacy of Mavrik on thrips in mango.
Study date
February 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264080
Title
Part 8 Efficacy and Safety Dossier - MAVRIK
Study date
November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
280856
Title
MAVRIK Aquaflow Insecticide - Draft Text Label
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
280852
Title
MAVRIK Aquaflow Insecticide: Part 5B - Overseas Trade
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
280853
Title
Determination of residues of tau-fluvalinate in tropical fruit following applications of MAVRIK. Australia, 2021-2023. S20-09671-01.
Study date
18 May 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
280854
Title
Determination of residues of tau-fluvalinate and its metabolites in macadamia following applications of MAVRIK. Australia, 2021. S20-09570-01.
Study date
1 December 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
280851
Title
MAVRIK Aquaflow Insecticide: Part 5A - Residues
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264081
Title
Part 5A Residues Dossier - MAVRIK
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
274014
Title
Residue study with tau-fluvalinate (SAN 527) in or on macadamia nuts in South Africa (R-14537).
Study date
23 October 2001
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
274015
Title
Residue study with tau-fluvalinate (SAN 527) in or on macadamia nuts in South Africa (R-14536).
Study date
23 October 2001
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
274016
Title
Residue study with tau-fluvalinate (SAN 527) in or on macadamia nuts in South Africa (R-14535).
Study date
23 October 2001
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
280855
Title
Storage stability of tau-fluvalinate in various crop matrices. R-13615.
Study date
27 March 1995
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264082
Title
Part 5B Trade Dossier - MAVRIK
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
274017
Title
Mavrik Aquaflow Insecticide s159 response
Study date
3 July 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
142422
Product/Active constituent Name
Application Product Name
Novali 835 SC Herbicide
Application Date
Application Number
142422
Application Product Name
Novali 835 SC Herbicide
Application details
Product name:
Novali 835 SC Herbicide
Product number:
94435
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 835 g/L Pyroxasulfone Suspension Concentrate (SC) product for control of Annual phalaris, Annual ryegrass, Barley grass, Great brome, Paradoxa grass, Silver grass, Toad rush and Wild oat in Wheat (not durum wheat), Triticale, Chickpeas, Field peas, Lentils and Lupin
Reference details:
82979 - Sakura Flow Herbicide
90790 - NOVALI 850 WG HERBICIDE
Active constituents:
Active constituent name
90190 - Pyroxasulfone
Active constituent name
94193 - PYROXASULFONE
Description of data provided:
Data no
264283
Title
Part Chemistry and Manufacturing
Study date
November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264289
Title
Method validation and determination of Pyroxasulfone content in one batch of ADM.06800.H.4.A
Study date
6 December 2022.
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264284
Title
Certificate of analysis of actives source 1
Study date
November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264285
Title
Certificate of analysis of actives source 2
Study date
November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264286
Title
Raw material SDS
Study date
November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264287
Title
Pyroxasulfone 835 SC Formulation Process
Study date
November 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264288
Title
R C2223: Physical and Chemical Properties and determination of accelerated storage stability (54??C for 2 weeks) of one batch of ADM.06800.H.4. A
Study date
18 July 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264301
Title
Part 8 Efficacy and Crop Safety
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264302
Title
Bioequivalence of ADM.06800.H.2.A and ADM.06800.H.1.D for control of annual ryegrass (Lolium rigidum) in chickpeas cv. Genesis090
Study date
21 March 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264303
Title
Bioequivalence of ADM.06800.H.2.A and ADM.06800.H.1.D on annual ryegrass (Lolium rigidum) in lupins
Study date
2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264306
Title
Evaluation of ADM.06800.H2.A applied solo and with various tank mix partners for pre-emergence weed control in wheat,
Study date
6 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264307
Title
Evaluation of ADM06800.H.2.A applied solo and with various tank mix partners for pre-emergence weed control in wheat,
Study date
30 March 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264308
Title
Efficacy of ADM.06800.H.2.A, applied pre-emergence, for the control of grasses and broadleaf weeds in chickpea cv. Monarch
Study date
31 January 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264309
Title
Proposed label
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264304
Title
Evaluation of the crop safety of ADM.06800.H.2.A 835 SC in various cereals
Study date
19 April 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264305
Title
Evaluation of the crop safety of ADM.06800.H.2.A 835 SC in various pulses
Study date
19 April 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264292
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A): Acute Dermal Toxicity Study In Wistar Rats (Fixed dose procedure)
Study date
24 January 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264297
Title
Evaluation of Pyroxasulfone 835 SC (ADM.06800.H.4.A) for Ocular Hazard Potential Using Bovine Corneal Opacity and Permeability Test.
Study date
22 November 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264295
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A): Acute Eye Irritation/Serious Eye Damage Study in New Zealand White Rabbits.
Study date
16 March 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264293
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A): Acute Inhalation Toxicity Study (Acute Toxic Class Method) In Wistar Rats
Study date
31 January 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264291
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A): Acute Oral Toxicity Study (Acute Toxic Class Method) In Wistar Rats
Study date
27 January 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264294
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A): Acute Dermal Irritation/Corrosion Study in New Zealand White Rabbits.
Study date
22 February 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264298
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A) ??? In vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method.
Study date
19 January 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264296
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A): Local Lymph Node Assay (LLNA) in CBA/Ca Mice
Study date
23 February 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264299
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A) ??? Bacterial Reverse Mutation test.
Study date
14 November 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264300
Title
Pyroxasulfone 835 SC (ADM.06800.H.4.A) ??? In-Vitro Mammalian Cell Micronucleus test in Human Peripheral Blood Lymphocytes.
Study date
23 February 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
264290
Title
Toxicology Novali 835 SC Herbicide
Study date
December 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
142436
Product/Active constituent Name
Application Product Name
TITAN EOS HERBICIDE
Application Date
Application Number
142436
Application Product Name
TITAN EOS HERBICIDE
Application details
Product name:
TITAN EOS HERBICIDE
Product number:
61860
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add plant desiccation and knockdown weed control in pulses to the label.
Reference details:
64177 - TITAN DIQUAT 200 NON-RESIDUAL HERBICIDE
87424 - TITAN PARAQUAT 360 HERBICIDE
Active constituents:
Active constituent name
56809 - PARAQUAT DICHLORIDE MANUFACTURING CONCENTRATE
Active constituent name
56808 - DIQUAT DIBROMIDE MANUFACTURING CONCENTRATE
Description of data provided:
Data no
264341
Title
Compare pre-harvest crop desiccation and efficacy of Titan EOS Herbicide to Paraquat and Diquat on annual ryegrass in lentils
Study date
November 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264342
Title
Compare pre-harvest crop desiccation of Titan EOS Herbicide to Paraquat and Diquat in lentils, and efficacy on annual ryegrass
Study date
December 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
281792
Title
Compare pre-harvest crop desiccation and efficacy of Titan EOS
Herbicide to Paraquat and Diquat on annual ryegrass in lentils
Herbicide to Paraquat and Diquat on annual ryegrass in lentils
Study date
December 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
281793
Title
Compare pre-harvest crop desiccation of Titan EOS Herbicide to
Paraquat and Diquat in lentils, and efficacy on annual ryegrass
Paraquat and Diquat in lentils, and efficacy on annual ryegrass
Study date
December 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
281794
Title
RESPONSE: TITAN EOS HERBICIDE 61860/142436
Study date
December 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
264343
Title
Overview: PROPOSED ADDITIONS TO TITAN EOS label
Study date
December 2023
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
277234
Title
RESPONSE: TITAN EOS HERBICIDE 61860/142436
Study date
September 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
142425
Product/Active constituent Name
Application Product Name
Ethephon
Application Date
Application Number
142425
Application Product Name
Ethephon
Application details
Product name:
Ethephon
Active name:
Ethephon
Applicant Name:
ZHUOCHEN INDUSTRIES (SHANGHAI) CO.,LTD.
Application purpose and description of use:
Approval of ETHEPHON for use in agricultural chemical products.
Description of data provided:
Data no
264330
Title
Final Report 0033 Five Batch Analysis of Ethephon TC-Confidential Attachment
Study date
January 03, 2020
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264331
Title
Final Report 0033-Five Batch Analysis of Ethephon TC
Study date
January 03, 2020
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264332
Title
Final Report 0034-Five Batch Analysis of Ethephon TC-Additional Impurities
Study date
January 03, 2020
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264333
Title
Final Report 0086-Five batch analysis of Ethephon TC-Additional Impurities
Study date
January 03, 2020
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264338
Title
DoC of Ethephon TC
Study date
December 25, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
275191
Title
revise DoC of Ethephon TC
Study date
July 21, 2024
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264334
Title
Manufacturer process and Impurities Justification of Ethephon TC
Study date
December 25, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264335
Title
The statement of batch size of Ethephon technical in 5-batch report
Study date
December 25, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264336
Title
Physical and chemical properties of Ethephon
Study date
December 25, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264339
Title
Consent from SHAOXING EASTLAKE HIGH-TECH CO., LTD.
Study date
December 20, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264340
Title
Letter of consent Nominated Agent
Study date
December 25, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Data no
264337
Title
Registration Data of Ethephon
Study date
December 25, 2023
Auth party contact address
Room 101, NO.38, Lane 431, Huyi Road, Jiading District Shanghai China
Date
Application Date
Application No
Application Number
142438
Product/Active constituent Name
Application Product Name
Propyzamide
Application Date
Application Number
142438
Application Product Name
Propyzamide
Application details
Product name:
Propyzamide
Active name:
Propyzamide
Applicant Name:
Chengwu Taihe Chemical Co., Ltd.
Application purpose and description of use:
Approval of Propyzamide for use in agricultural chemical products.
Description of data provided:
Data no
264345
Title
Analysis method for Propyzamide
Study date
30/06/2023
Auth party contact address
Chemical Industry Zone Chengwu, Heze Shandong China
Data no
264344
Title
Five Batch Analysis of Propyzamide Technical
Study date
07/12/2023
Auth party contact address
Chemical Industry Zone Chengwu, Heze Shandong China
Data no
264348
Title
Certificate of Analysis
Study date
30/06/2023
Auth party contact address
Chemical Industry Zone Chengwu, Heze Shandong China
Data no
264346
Title
Method of manufacture of Propyzamide
Study date
01/06/2023
Auth party contact address
Chemical Industry Zone Chengwu, Heze Shandong China
Data no
264347
Title
Declaration of Composition
Study date
2024
Auth party contact address
Chemical Industry Zone Chengwu, Heze Shandong China
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
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
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
284437
Title
Repellency Efficacy data Screen2P Wear
Study date
03/02/2025
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
285287
Title
Repellency Efficacy data Screen2P Wear
Study date
03/02/2025
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
Data no
281443
Title
Skin Sensitization Study Permethrin
Study date
27/10/2007
Auth party contact address
30 SOUTH ST RYDALMERE 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
285286
Title
Repellency Efficacy data Screen2P Wear
Study date
03/02/2025
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
285403
Title
Skin sen (40_60) LLNA
Study date
07/04/2011
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
285404
Title
9. SCREEN 2P WEAR - insecticide efficacy Resultat
Study date
2024
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
285405
Title
9. SCREEN 2P WEAR - Culex Anopheles - insecticide efficacy
Study date
2024
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
263524
Title
Screen2P Wear (Non-Perfumed) 100ml Label
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
Data no
281442
Title
Skin Sensitization of Permethrin
Study date
22/10/2007
Auth party contact address
30 SOUTH ST RYDALMERE Australia
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
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
285487
Title
32s44-batch-analyses
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285485
Title
32s21-manufacturer
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285486
Title
32s41-specification
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
282547
Title
2025-01-23 - Datalist to RM - Datalist to be uploaded - 94343/142149
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
282548
Title
comparative-table
Study date
2024
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
285488
Title
32p6-reference-standards
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285489
Title
app-1-coa-working-standard-uspep
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
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
Data no
285492
Title
app-1-coa
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285490
Title
Appendix 4.6
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285491
Title
508037
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285493
Title
EU 6.0 PART m3 32p44 app1
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285432
Title
Single-dose ropinirole hydrochloride toxicity study in rats and monkeys
Study date
1996
Auth party contact address
-
Data no
285399
Title
511188
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285401
Title
Neoplastic Lesions of Questionable Significance to Humans
Study date
1994
Data no
285420
Title
Endometrial Stromal Polyps in Rodents: Biology, Etiology, and Relevance to Disease in Women
Study date
2012
Auth party contact address
-
Data no
285417
Title
Update on genotoxicity and carcinogenicity testing of 472 marketed pharmaceuticals
Study date
2009
Auth party contact address
-
Data no
285428
Title
Hyperplastic Endometrial Polyps in the Dog and Cat
Study date
1984
Auth party contact address
-
Data no
285439
Title
Ropinirole: Oral Reproductive and Developmental Toxicity Studies in Rats and Rabbits
Study date
1996
Auth party contact address
-
Data no
285435
Title
Cytogenetic, Biochemical and Histopathological Effects of Ropinirole on Albino Male Mice
Study date
2015
Auth party contact address
-
Data no
285484
Title
8333411
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285408
Title
Other requirements
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285400
Title
8333410
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285395
Title
Appendix 1a.1
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285396
Title
Appendix 1b.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285397
Title
Appendix 38.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285398
Title
Appendix 38.2
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285409
Title
User risk assessment
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285406
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
285407
Title
Toxicology
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285411
Title
Nanocarrier for the Transdermal Delivery of an Antiparkinsonian Drug
Study date
2009
Auth party contact address
-
Data no
285412
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
285414
Title
Population pharmacokinetics of ropinirole in patients with Parkingson's disease
Study date
1997
Auth party contact address
-
Data no
285415
Title
In vitro identification of the P450 enzymes responsible for the metabolism of ropinirole
Study date
1997
Auth party contact address
-
Data no
285421
Title
ADMET considerations for restless leg syndrome drug treatments
Study date
2012
Auth party contact address
-
Data no
285422
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
285424
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
285425
Title
Preclinical Pharmacology of Ropinirole (SK F 101468-A) a Novel Dopamine D2 Agonist
Study date
1991
Auth party contact address
-
Data no
285494
Title
Ropinirole - Literature Review
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285495
Title
Preclinical Evaluation of Application for Registration 1
Study date
1996
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285496
Title
Nonclinical Evaluation Report 2
Study date
2003
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
285436
Title
Controlled delivery of ropinirole hydrochloride through skin using modulated iontophoresis and microneedles
Study date
2013
Auth party contact address
-
Data no
285437
Title
Repeat-Dose Oral Toxicity of Ropinirole in Cynomolgus Monkeys
Study date
1996
Auth party contact address
-
Data no
285438
Title
Repeat-Dose Oral Toxicity of Ropinirole in Rats
Study date
1996
Auth party contact address
-
Data no
285418
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
285433
Title
Clinical Pharmacokinetics of Ropinirole
Study date
2000
Auth party contact address
-
Data no
285434
Title
Comparative Pharmacological Study of Ropinirole (SKF-101468) and its Metabolites in Rats
Study date
2000
Auth party contact address
-
Data no
285430
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
285431
Title
Dopamine receptor agonists differ in their actions on cardiac ion channels
Study date
2003
Auth party contact address
-
Data no
285419
Title
Effectiveness of ropinirole for RLS and depressive symptoms in an 11-year-old girl
Study date
2009
Auth party contact address
-
Data no
285429
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
285440
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
285426
Title
Falling asleep at the wheel: motor vehicle mishaps in persons taking pramipexole and ropinirole
Study date
1999
Auth party contact address
-
Data no
285427
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
285423
Title
Rare and Serious Cardiac Side Effects During Ropinirole Titration
Study date
2010
Auth party contact address
-
Data no
285416
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
285413
Title
Ropinirole Monotherapy Induced Severe Reversible Dyskinesias in Parkinson?s Disease
Study date
2013
Auth party contact address
-
Data no
285410
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
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
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
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
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
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
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
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
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
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
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
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
262778
Title
32p45-excipients-human-animal
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
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
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
262550
Title
Appendix 7.1
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
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
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
262603
Title
13000038
Study date
2013
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
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
262731
Title
SPC Emedog
Study date
2015
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
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
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
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
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
262669
Title
Development of resistance
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
262578
Title
Appendix 15.1
Study date
2017
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
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
262717
Title
Dopamine receptor agonists differ in their actions on cardiac ion channels
Study date
2003
Auth party contact address
-
Data no
262589
Title
Pharmacology
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
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
262668
Title
Pharmacology
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
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
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
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
262712
Title
Population pharmacokinetics of ropinirole in patients with Parkingson's disease
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
262670
Title
Tolerance in target animal species
Study date
2023
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
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
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
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
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
262598
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
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
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
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
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
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
262536
Title
Clevor - response template - D120
Study date
2017
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
262646
Title
Product Monograph
Study date
2008
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
262591
Title
Other requirements
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
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
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
262664
Title
Pharmacokinetics of Dopamine-2 Agonists in Rats and Dogs
Study date
1986
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
262650
Title
RIVM report
Study date
2023
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
262659
Title
Movement disorders in pregnancy
Study date
2004
Auth party contact address
-
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
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
262647
Title
Disposition of ropinirole in animals and man
Study date
1999
Auth party contact address
-
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
262811
Title
Medicines Complete Database
Study date
2023
Auth party contact address
-
Data no
262851
Title
Ropinirole: current status of the studies.
Study date
2004
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
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
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
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
-
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