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
145211
Product/Active constituent Name
Application Product Name
Cropnosys Azoxystrobin 250 SC Fungicide
Application Date
Application Number
145211
Application Product Name
Cropnosys Azoxystrobin 250 SC Fungicide
Application details
Product name:
Cropnosys Azoxystrobin 250 SC Fungicide
Product number:
95297
Applicant Name:
CROPNOSYS INDIA PRIVATE LIMITED
Application purpose and description of use:
Registration of a 250 g/L soluble concentrate formulation of azoxystrobin for the control of control of various diseases of Grapes, Potatoes, Tomatoes, Cucurbits, Avocados, Mangoes, Passionfruit and Poppies, as per the Directions for Use.
Reference details:
84248 - Raystar Azoxystrobin 250SC Fungicide
Active constituents:
Active constituent name
64896 - AZOXYSTROBIN
Date
Application Date
Application No
Application Number
145190
Product/Active constituent Name
Application Product Name
Cropnosys Diflufenican 500 SC Herbicide
Application Date
Application Number
145190
Application Product Name
Cropnosys Diflufenican 500 SC Herbicide
Application details
Product name:
Cropnosys Diflufenican 500 SC Herbicide
Product number:
95287
Applicant Name:
CROPNOSYS INDIA PRIVATE LIMITED
Application purpose and description of use:
Registration of a 500 g/L suspension concentrate of diflufenican for the control of certain weeds in clover-based Pasture, Field Peas, Lentils, Lupins and Oilseed Poppy as specified in the Directions for Use table
Reference details:
85293 - Diflukey Herbicide
Active constituents:
Active constituent name
69078 - DIFLUFENICAN
Date
Application Date
Application No
Application Number
145189
Product/Active constituent Name
Application Product Name
Cropnosys Propaquizafop 100EC Herbicide
Application Date
Application Number
145189
Application Product Name
Cropnosys Propaquizafop 100EC Herbicide
Application details
Product name:
Cropnosys Propaquizafop 100EC Herbicide
Product number:
95286
Applicant Name:
CROPNOSYS INDIA PRIVATE LIMITED
Application purpose and description of use:
Registration of a 100 g/L emulsifiable concentrate of propaquizafop for post-emergence selective weed control of annual grasses in broadleaf crops and legume pastures as specified in the Directions for Use table.
Reference details:
60764 - SHOGUN HERBICIDE
Active constituents:
Active constituent name
44365 - PROPAQUIZAFOP
Date
Application Date
Application No
Application Number
145183
Product/Active constituent Name
Application Product Name
PROPENTOFYLLINE
Application Date
Application Number
145183
Application Product Name
PROPENTOFYLLINE
Application details
Product name:
PROPENTOFYLLINE
Active name:
PROPENTOFYLLINE
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Approval of Propentofylline source for use in veterinary chemical products
Description of data provided:
Data no
276906
Title
Analytical test procedure AI site
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276907
Title
Validation of Analytical Procedure AI Site Summary
Study date
December 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276908
Title
Analytical method validation protocol & report for related substances by HPLC
Study date
8 September 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276909
Title
Analytical method validation protocol & report for Assay by HPLC
Study date
19 August 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276910
Title
Analytical method validation protocol & report determination residual solvents by GC-HS
Study date
21 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276911
Title
Analytical method verification protocol & report of DSC method
Study date
22 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276912
Title
Analytical method verification protocol & report of PSD method
Study date
24 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276913
Title
Analytical method verification protocol & report for identification by FTIR
Study date
24 October 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276914
Title
Batch Analyses & Results AI-Site
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276915
Title
CoA J13910223_001
Study date
2 August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276916
Title
CoA J13910223_002
Study date
2 August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276917
Title
CoA J13910223_003
Study date
2 August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276918
Title
CoA J13910223_004
Study date
2 August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276919
Title
CoA J73910223_001
Study date
2 August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276892
Title
CoA 0000707863 MSD
Study date
21 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276893
Title
CoA 0000728313 MSD
Study date
22 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276894
Title
CoA 0000728313 MSD
Study date
22 August 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276895
Title
CoA 0000732422 MSD New Site
Study date
9 November 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276896
Title
CoA 0000732420 MSD New Site
Study date
9 November 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276897
Title
CoA 0000732423 MSD New Site
Study date
9 November 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276889
Title
Comparison Batch analyses results
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276890
Title
API Specification_Aug2019
Study date
August 2019
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276898
Title
Hygroscopicity Report
Study date
26 May 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276899
Title
Manufacturing process new AI site
Study date
December 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276900
Title
Structural Elucidation Report (3 batches)
Study date
20 June 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276901
Title
Impurities new AI site
Study date
April 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276902
Title
Fate & Purge Report
Study date
29 September 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276903
Title
Assessment and Control of DNA Reactive Genotoxic (Mutagenic) Impurities
Study date
30 March 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276904
Title
Initial Risk Assessment Report
Study date
30 March 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276905
Title
Standard specification new AI site
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276920
Title
Justification of specification AI-site
Study date
December 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276891
Title
Expert Report
Study date
15 July 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276886
Title
ASMFv4 Part 1_Aug2024
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276887
Title
ASMFv4 Part 2_Aug2024
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276888
Title
Executive Summary
Study date
21 August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276921
Title
Forced Degradation Study Protocol AI-site
Study date
25 November 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276922
Title
Forced Degradation Study Report AI-site
Study date
12 January 2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276923
Title
Stability data AI-Site
Study date
August 2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
144883
Product/Active constituent Name
Application Product Name
SWIFT POUR-ON FOR SHEEP
Application Date
Application Number
144883
Application Product Name
SWIFT POUR-ON FOR SHEEP
Application details
Product name:
SWIFT POUR-ON FOR SHEEP
Product number:
95184
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a 4.0 mg/ml abamectin and 35.0 mg/ml imidacloprid liquid pour-on product for the treatment and control of susceptible strains of lice (Bovicola ovis) on sheep, including synthetic pyrethroid resistant lice, when applied up to 7 days after shearing.
Reference details:
85544 - FENNEC POUR-ON FOR SHEEP
Active constituents:
Active constituent name
83130 - Abamectin
Active constituent name
83018 - Imidacloprid
Description of data provided:
Data no
275790
Title
Swift Pour-On for Sheep Specifications
Study date
21-Jun-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
281709
Title
Updated product specifications
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
283295
Title
Updated product specifications
Study date
13/02/2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
281708
Title
Response to Section 159(1)(a) notice for application 95184/144883, Swift Pour-On for Sheep
Study date
27-11-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
145080
Product/Active constituent Name
Application Product Name
Chlorfenapyr
Application Date
Application Number
145080
Application Product Name
Chlorfenapyr
Application details
Product name:
Chlorfenapyr
Active name:
Chlorfenapyr
Applicant Name:
SHANDONG XINLONG GROUP BIOTECHNOLOGY CO LTD
Application purpose and description of use:
Approval of Chlorfenapyr technical grade material for use in agricultural chemical products.
Description of data provided:
Data no
276745
Title
Preliminary Analysis and Enforcement Analytical Method of CHLORFENAPYR TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of CHLORFENAPYR TC
Study date
14/09/2021
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
276746
Title
Preliminary Analysis and Enforcement Analytical Method of CHLORFENAPYR TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of CHLORFENAPYR TC
Study date
05/2021
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
276747
Title
Declaration of composition - Chlorfenapyr TC
Study date
08/08/2024
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
282845
Title
Active and impurities identification
Study date
2021
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
282846
Title
Five-batch analysis data
Study date
2021
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
276744
Title
Manufacturing Process of Chlorfenapyr TC and Impurities Justification
Study date
13/12/2021
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Date
Application Date
Application No
Application Number
144731
Product/Active constituent Name
Application Product Name
AURAZOL MINIDOSE CATTLE DRENCH
Application Date
Application Number
144731
Application Product Name
AURAZOL MINIDOSE CATTLE DRENCH
Application details
Product name:
AURAZOL MINIDOSE CATTLE DRENCH
Product number:
95117
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
Registration of a 112.5 g/L ALBENDAZOLE Oral Drench product is proposed for the control of benzimidazole-sensitive mature and immature gastrointestinal roundworms (including inhibited type II Ostertagia larvae), lungworms, tapeworms and to aid in the control of adult liver fluke in cattle. It also reduces the output of viable worm and fluke eggs and for hook drenching of beef and dairy cattle.
Reference details:
85538 - INDEPENDENTS OWN ALBEMAX MINI-DOSE CATTLE DRENCH
Description of data provided:
Data no
274371
Title
Finished Product Specs
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145186
Product/Active constituent Name
Application Product Name
eChem Promid 500 WG Herbicide
Application Date
Application Number
145186
Application Product Name
eChem Promid 500 WG Herbicide
Application details
Product name:
eChem Promid 500 WG Herbicide
Product number:
95283
Applicant Name:
ECHEM (AUST) PTY LIMITED
Application purpose and description of use:
Registration of a 500 g/kg propyzamide water dispersible granule product for selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures
Reference details:
88974 - Sabakem Propyzamide 500 WG Herbicide
Active constituents:
Active constituent name
80007 - PROPYZAMIDE
Date
Application Date
Application No
Application Number
145219
Product/Active constituent Name
Application Product Name
ILIUM TEMVET INJECTION
Application Date
Application Number
145219
Application Product Name
ILIUM TEMVET INJECTION
Application details
Product name:
ILIUM TEMVET INJECTION
Product number:
67612
Applicant Name:
TROY LABORATORIES PTY LTD
Application purpose and description of use:
Variation of registration to amend product formulation.
Active constituents:
Active constituent name
81514 - BUPRENORPHINE HYDROCHLORIDE
Active constituent name
81514 - BUPRENORPHINE HYDROCHLORIDE
Description of data provided:
Data no
277203
Title
Supporting information
Study date
2024
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Date
Application Date
Application No
Application Number
144732
Product/Active constituent Name
Application Product Name
Albendazole
Application Date
Application Number
144732
Application Product Name
Albendazole
Application details
Product name:
Albendazole
Active name:
Albendazole
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
276301
Title
Active Certificates of analysis
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
279807
Title
AURA - Albendazole API -Qquery response - Justification for residual solvent ' Mesityl oxide' limits in the COA
Study date
October 2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145160
Product/Active constituent Name
Application Product Name
F.S.A. 24DB Herbicide
Application Date
Application Number
145160
Application Product Name
F.S.A. 24DB Herbicide
Application details
Product name:
F.S.A. 24DB Herbicide
Product number:
87501
Applicant Name:
FOUR SEASONS AGRIBUSINESS PTY LTD
Application purpose and description of use:
Variation of product registration to update formulation.
Active constituents:
Active constituent name
68528 - 2,4-DB
Active constituent name
47083 - 2,4-DB
Description of data provided:
Data no
277183
Title
Consent For Use of Confidential Commercial Information
Study date
19 August 2024
Data no
277184
Title
Formulation details for the above reference product
Study date
19 August 2024
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026
Date
Application Date
Application No
Application Number
145204
Product/Active constituent Name
Application Product Name
BIMACURE CEPHAPIRIN BENZATHINE INTRA-UTERINE SUSPENSION FOR CATTLE
Application Date
Application Number
145204
Application Product Name
BIMACURE CEPHAPIRIN BENZATHINE INTRA-UTERINE SUSPENSION FOR CATTLE
Application details
Product name:
BIMACURE CEPHAPIRIN BENZATHINE INTRA-UTERINE SUSPENSION FOR CATTLE
Product number:
94400
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Variation of product registration to vary relevant particulars.
Active constituents:
Active constituent name
94401 - cephapirin benzathine
Description of data provided:
Data no
277074
Title
GMP
Study date
2022
Auth party contact address
-
Date
Application Date
Application No
Application Number
145200
Product/Active constituent Name
Application Product Name
RAZOR EQUINE WORMER
Application Date
Application Number
145200
Application Product Name
RAZOR EQUINE WORMER
Application details
Product name:
RAZOR EQUINE WORMER
Product number:
59467
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration to extend the product shelf life
Active constituents:
Active constituent name
80904 - PRAZIQUANTEL
Active constituent name
56221 - PRAZIQUANTEL
Active constituent name
81934 - Praziquantel
Active constituent name
55643 - IVERMECTIN
Active constituent name
83261 - Praziquantel
Active constituent name
52892 - IVERMECTIN
Active constituent name
84516 - IVERMECTIN
Active constituent name
52892 - IVERMECTIN
Active constituent name
84516 - IVERMECTIN
Active constituent name
80904 - PRAZIQUANTEL
Description of data provided:
Data no
277023
Title
Active RS 1
Study date
Dec 2022
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277020
Title
Executive summary
Study date
Aug 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277026
Title
Test method - preservatives
Study date
Jan 2012
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277021
Title
Final stability report
Study date
Jul 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277024
Title
Active RS 2
Study date
Sep 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277022
Title
CoAs
Study date
July 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277025
Title
Test methods - microbiology
Study date
Aug 2024
Auth party contact address
-
Date
Application Date
Application No
Application Number
144890
Product/Active constituent Name
Application Product Name
Pregabalin
Application Date
Application Number
144890
Application Product Name
Pregabalin
Application details
Product name:
Pregabalin
Product number:
95189
Applicant Name:
MAVLAB ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 50 mg/mL pregabalin oral solution product for the alleviation of acute anxiety and fear in cats associated with transportation and veterinary visits, in conjunction with approval of pregabalin.
Description of data provided:
Data no
276765
Title
ASMF (Restricted) 3.2.S.2.2 Description of manufacturing procedures
Study date
August 2023
Data no
276766
Title
ASMF (Restricted) 3.2.S.2.3 Control of Materials
Study date
2023
Data no
276767
Title
ASMF (Restricted) 3.2.S.2.4 Controls of Critical Steps and Intermediates
Study date
2023
Data no
276768
Title
ASMF (Restricted) 3.2.S.2.5 Process Validation and/or Evaluation
Study date
2023
Auth party contact address
;
Data no
276769
Title
ASMF (Restricted) 3.2.S.2.6 Manufacturing Process Development
Study date
2019
Date
Application Date
Application No
Application Number
144891
Product/Active constituent Name
Application Product Name
Bonqat 50 mg/mL Oral Solution for Cats
Application Date
Application Number
144891
Application Product Name
Bonqat 50 mg/mL Oral Solution for Cats
Application details
Product name:
Bonqat 50 mg/mL Oral Solution for Cats
Product number:
95190
Applicant Name:
MAVLAB ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 50 mg/mL pregabalin oral solution product for the alleviation of acute anxiety and fear in cats associated with transportation and veterinary visits, in conjunction with approval of pregabalin.
Description of data provided:
Data no
276116
Title
ASMF (Open) 3.2.S.4.2 Analytical procedures
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276117
Title
ASMF (Open) 3.2.S.4.3 Validation of analytical procedures
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276118
Title
ASMF (Open) 3.2.S.4.4 Batch analyses
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275832
Title
Active constituent CoAs
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275833
Title
pregabalin-cep
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276119
Title
ASMF (Open) 3.2.S.4.5 Justification of specifications
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276111
Title
ASMF (Open) 3.2.S.2.1 Manufacturers
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276112
Title
ASMF (Open) 3.2.S.2.2 Description of manufacturing procedures
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276115
Title
ASMF (Open) 3.2.S.4.1 Specification
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276057
Title
3.2.S.4.1 Specification
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276047
Title
QOS-2-3-s-drug-substance
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276113
Title
ASMF (Open) 3.2.S.3.1 Elucidation of structure
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276114
Title
ASMF (Open) 3.2.S.3.2 Impurities
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276108
Title
ASMF (Open) 3.2.S.1.1 Nomenclature
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276109
Title
ASMF (Open) 3.2.S.1.2 Structure
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276110
Title
ASMF (Open) 3.2.S.1.3 General properties
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276120
Title
ASMF (Open) 3.2.S.5 Reference standards
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276121
Title
ASMF (Open) 3.2.S.6 Container closure system
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276122
Title
ASMF (Open) 3.2.S.7.1 Stability summary
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276123
Title
ASMF (Open) 3.2.S.7.2 Post-approval stability
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276124
Title
ASMF (Open) 3.2.S.7.3 Stability data
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276086
Title
3.2.P.5.2 Analytical Procedures
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276087
Title
M122238 Deliverable volume
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276088
Title
M122961 Clarity colour NZ AU
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276089
Title
M123145 Sodium Benzoate
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276090
Title
M123146 UHPLC NZ AU
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276091
Title
USP-NF 698
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276092
Title
3.2.P.5.3 Validation of Analytical Procedures
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276093
Title
Suitability study micro impurities
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276094
Title
Validation report UHPLC method
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276095
Title
Validation report-Sodium benzoate assay
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276063
Title
3.2.P.4.2 Analytical Procedures
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276064
Title
M122848 ID by IR
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276065
Title
M122850 Residue on Ignition
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276066
Title
M122851 Water
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276067
Title
M123930 ID assay organic impurities
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276068
Title
USP-NF 197 Spectro ID Tests
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276069
Title
USP-NF 921 Water determination
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275841
Title
Response to D120 LoQ: Appendix 15-2
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276085
Title
3.2.P.5.4 Batch Analyses
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276049
Title
3.2.P.2.1 Descr and Composition-Drug Product
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276050
Title
3.2.P.3.2 Batch Formula
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276051
Title
3.2.P.2.1 Components of Drug Product
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276052
Title
3.2.P.2.2 Drug Product
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276058
Title
3.2.P.4.1 Specifications_2
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276059
Title
3.2.P.4.3 Validation Analyt Proc
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276060
Title
3.2.P.4.4 Justification Specifications
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276054
Title
3.2.P.2.4 Container Closure System
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276055
Title
3.2.P.2.5 Microbiol Attributes
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276056
Title
3.2.P.2.6 Compatibility
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276082
Title
3.2.P.5.1 Specifications EU
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276083
Title
3.2.P.5.5 Characterisation Impurities
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276084
Title
3.2.P.5.6 Justification Specifications
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276070
Title
3.2.P.3.1 Manufacturers 4
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276071
Title
3.2.P 3.3 Description Manufacturing Process and Controls EU
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276072
Title
3.2.P.3.5 Process Validation and or Evaluation
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276073
Title
3.2.P.3.4 Controls Critical Steps and Intermediates
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275885
Title
CVMP additional response
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275836
Title
Response to D120 LoQ: Appendix 1-1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275837
Title
Response to D120 LoQ: Appendix 1b.1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275838
Title
Response to D120 LoQ: Appendix 13-1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275839
Title
Response to D120 LoQ: Appendix 13-2
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275840
Title
Response to D120 LoQ: Appendix 15-1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275870
Title
Response to D180 LoOI: Appendix 4-1
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276074
Title
3.2.P.7 Container Closure System
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276075
Title
Compliance cert-child resistant closure
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276076
Title
Compliance cert-closure with adapter
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276077
Title
Compliance cert-glass bottle
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276078
Title
Compliance cert-measuring device
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276079
Title
Drawing-typeIII glass bottle 5ml
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276080
Title
Tech drawing-measuring device
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276061
Title
3.2.P.4.5 Excipients of Human or Animal Origin
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276062
Title
3.2.P.4.6 Novel Excipients
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276053
Title
3.2.P.2.3 Manuf Process Devt EU
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276048
Title
QOS-2-3-r-regional-information
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276045
Title
Quality Overall Summary - introduction
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276046
Title
QOS-2-3-p-drug-product
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276096
Title
3.2.P.8.1 Stability Summary and Conclusions AU NZ
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276097
Title
3.2.P.8.2 Post-approval stability commitment CH
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276098
Title
3.2.P.8.3 Stability data
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276099
Title
Results primary stability BN 1901424
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276100
Title
Results primary stability BN 1901426
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276101
Title
Results primary stability BN 1903372
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276102
Title
Results-freeze thaw study
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276103
Title
Results-photostability
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276104
Title
Results - in-use stability
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276105
Title
Results-in-use stability end shelf life
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276107
Title
Stability ST excursions
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276005
Title
Vital statistics
Study date
2013
Auth party contact address
-
Data no
276029
Title
Pregabalin may represent a novel class of anxiolytic agents with a broad spectrum of activity
Study date
2001
Auth party contact address
-
Data no
276036
Title
Summary of Product Characteristics
Study date
2017
Auth party contact address
-
Data no
276043
Title
Anxiolytic-like effect of pregabalin on unconditioned fear in the rat: An autoradiographic brain perfusion mapping and functional connectivity study
Study date
2012
Auth party contact address
-
Data no
276044
Title
Brief post-stressor treatment with pregabalin in an animal model for PTSD: Short-term anxiolytic effects without long-term anxiogenic effect
Study date
2008
Auth party contact address
-
Data no
275965
Title
Efficacy Report No. V3120001
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275966
Title
Efficacy Report No. V3120002
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275967
Title
Pharmacology Report No. 510825
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275962
Title
Cat owner survey report
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276008
Title
2015 AAHA Canine and Feline Behavior Management Guidelines
Study date
2015
Auth party contact address
-
Data no
276009
Title
Guardians' Perceptions of Cats' Welfare and Behavior Regarding Visiting Veterinary Clinics
Study date
2016
Auth party contact address
-
Data no
276010
Title
The perception of cat stress by Italian owners
Study date
2017
Auth party contact address
-
Data no
276011
Title
A triple blind placebo-controlled investigation into the assessment of the effect of Dog Appeasing Pheromone (DAP) on anxiety related behaviour of problem dogs in the veterinary clinic
Study date
2006
Auth party contact address
-
Data no
276012
Title
Comparison of stress exhibited by cats examined in a clinicversus a home setting
Study date
2015
Auth party contact address
-
Data no
276013
Title
Evaluation of the effects of hospital visit stress on physiologic parameters in the cat
Study date
2011
Auth party contact address
-
Data no
276014
Title
Take your cat to the vet day
Study date
2016
Auth party contact address
-
Data no
276015
Title
Efficacy of a single dose of trazodone hydrochloride given to cats prior to veterinary visits to reduce signs of transport- and examination-related anxiety
Study date
2016
Auth party contact address
-
Data no
276016
Title
Effects of a single preappointment dose of gabapentin on signs of stress in cats during transportation and veterinary examination
Study date
2017
Auth party contact address
-
Data no
276017
Title
Executive summary of the Bayer veterinary care usage study
Study date
2017
Auth party contact address
-
Data no
276018
Title
Auxiliary subunits: essential components of the voltage-gated calcium channel complex
Study date
2003
Auth party contact address
-
Data no
275842
Title
Response to D120 LoQ: Appendix 41-1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275843
Title
Response to D120 LoQ: Appendix 42-1
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275844
Title
Response to D120 LoQ: Appendix 42-2
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275856
Title
Owner observations can provide data for constructive behavior analysis in normal pet cats in Australia
Study date
2008
Auth party contact address
-
Data no
275952
Title
Development of resistance
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275886
Title
Detailed and Critical Summary on Safety
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275887
Title
Expert CV
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275888
Title
Safety of Pregabalin in Pregnancy
Study date
2019
Auth party contact address
-
Data no
275889
Title
Detailed and Critical Summary on Efficacy
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275890
Title
Expert CV
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275891
Title
Tabular formats
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275892
Title
Cat Culture, Human Culture: An Ethnographic Study of a Cat Shelter
Study date
1999
Auth party contact address
-
Data no
275893
Title
Why Do People Love Their Pets
Study date
1997
Auth party contact address
-
Data no
275894
Title
Separation, Confinement, or Noises: What Is Scaring That Dog?
Study date
2018
Auth party contact address
-
Data no
275895
Title
hapter 15 Chemical control of the brain and behaviour: The diffuse modulatory systems of the brain. In Neuroscience: Exploring the Brain.
Study date
2007
Auth party contact address
-
Data no
275896
Title
Effects of alpha-casozepine (Zylkene) versus selegiline hydrochloride (Selfian, Anipryl) on anxiety disorders in dogs
Study date
2009
Auth party contact address
-
Data no
275897
Title
Future Directions in Human-Animal Bond Research
Study date
2003
Auth party contact address
-
Data no
275898
Title
Manifestations of chronic and acute stress in dogs
Study date
1997
Auth party contact address
-
Data no
275899
Title
Behavioural, saliva cortisol and heart rate responses to different types of stimuli in dogs
Study date
1998
Auth party contact address
-
Data no
275900
Title
Psychosocial and psychophysiological effects of human-animal interactions: the possible role of oxytocin.
Study date
2012
Auth party contact address
-
Data no
275901
Title
Chapter 26 Drugs that modify animal behaviour. In Small Animal Clinical Pharmacology and Therapeutics.
Study date
2011
Auth party contact address
-
Data no
275902
Title
Chapter 6 The role of pharmacology in behavioural medicine. In Behaviour Problems in Small Animals: Practical Advice for the Veterinary Team.
Study date
2005
Auth party contact address
-
Data no
275903
Title
Trazodone: A review of its pharmacological properties and its off-label use in dogs and cats
Study date
2017
Auth party contact address
-
Data no
275904
Title
Caregiver placebo effect for dogs with lameness from osteoarthritis.
Study date
2012
Auth party contact address
-
Data no
275905
Title
Gabapentin as an adjuvant for postoperative pain management in dogs undergoing mastectomy
Study date
2015
Auth party contact address
-
Data no
275906
Title
Benzodiazepines: pros and cons for fear and anxiety
Study date
2008
Auth party contact address
-
Data no
275907
Title
Chapter 6 Introduction to clinical psychopharmacology for veterinary medicine, Chapter 7 Benzodiazepines, Chapter 10 Anticonvulsants and mood stabilizers. In Veterinary Psychopharmacology.
Study date
2019
Auth party contact address
-
Data no
275908
Title
Cortisol effect on (Na++K+)-stimulated ATPase activity and on bilayer fluidity of dog brain synaptosomal plasma membranes.
Study date
1985
Auth party contact address
-
Data no
275909
Title
Chapter 5 Pharmacologic treatment of fear and anxiety in animals. In Psychopharmacology of animal behavior disorders.
Study date
1998
Auth party contact address
-
Data no
275910
Title
Cortisol-Induced Impairments of Working Memory Require Acute Sympathetic Activation
Study date
2005
Auth party contact address
-
Data no
275911
Title
Pharmacology: new antidepressants
Study date
1980
Auth party contact address
-
Data no
275912
Title
Chapter 1 Understanding Our Kinship with Animals: Input for Health Care Professionals Interested in the Human-Animal Bond. In: Handbook on Animal-Assisted Therap. 4th Edition
Study date
2015
Auth party contact address
-
Data no
275913
Title
Chapter 9 Animals and therapists: Incorporating animals in outpatient psychotherapy. In handbook on animal assisted therapy: Theoretical foundations and guidelines for practice.
Study date
2000
Auth party contact address
-
Data no
275914
Title
The human-companion animal bond: how humans benefit
Study date
2009
Auth party contact address
-
Data no
275915
Title
Use of trazodone as an adjunctive agent in the treatment of canine anxiety disorders: 56 cases
Study date
2008
Auth party contact address
-
Data no
275916
Title
Assessment of the effects of gabapentin on activity levels and owner-perceived mobility impairment and quality of life in osteoarthritic geriatric cats
Study date
2018
Auth party contact address
-
Data no
275917
Title
The view from All Fours: A Look at an Animal-Assisted Activity Program from the Animal's Perspective
Study date
2007
Auth party contact address
-
Data no
275918
Title
Psychogenic Stress in Hospitalized Dogs: Cross Species Comparisons, Implications for Health Care, and the Challenges of Evaluation
Study date
2014
Auth party contact address
-
Data no
275919
Title
Changes in the stress markers cortisol and glucose before and during intradermal testing in cats after single administration of pre-appointment gabapentin
Study date
2020
Auth party contact address
-
Data no
275920
Title
Owner observations can provide data for constructive behavior analysis in normal pet cats in Australia
Study date
2008
Auth party contact address
-
Data no
275921
Title
Dexmedetomidine oromucosal gel for noise-associated acute anxiety and fear in dogs - a randomised, double-blind, placebo-controlled clinical study.
Study date
2017
Auth party contact address
-
Data no
275922
Title
Chapter 8 Pharmacologic intervention in behavioural therapy. In Behavior Problems of the Dog and Cat 3rd edition
Study date
2011
Auth party contact address
-
Data no
275923
Title
Minimising stress for patients in the veterinary hospital: Why it is important and what can be done about it
Study date
2017
Auth party contact address
-
Data no
275924
Title
Chapter 1 From trust to domination. In Animals and human society: Changing perspectives.
Study date
1994
Auth party contact address
-
Data no
275925
Title
Guardians perceptions of cats welfare and behavior regarding visiting veterinary clinics.
Study date
2016
Auth party contact address
-
Data no
275926
Title
Human-cat interactions in the home setting
Study date
1991
Auth party contact address
-
Data no
275927
Title
Placebo effect in canine epilepsy trials
Study date
2010
Auth party contact address
-
Data no
275928
Title
Science-based assessment of animal welfare: companion animals
Study date
2005
Auth party contact address
-
Data no
275929
Title
The role of phenylethylamine during positive human-dog interaction
Study date
2000
Auth party contact address
-
Data no
275930
Title
The use of clonidine in the treatment of fear-based behavior problems in dogs: an open trial
Study date
2011
Auth party contact address
-
Data no
275931
Title
Use of oral trazodone for sedation in cats: a pilot study
Study date
2015
Auth party contact address
-
Data no
275933
Title
Use of single-dose oral gabapentin to attenuate fear responses in cage-trap confined community cats: a double-blind, placebo-controlled field trial
Study date
2017
Auth party contact address
-
Data no
275934
Title
Diazepam, Gabapentin. In Plumb's Veterinary Drug Handbook 8th edition
Study date
2015
Auth party contact address
-
Data no
275935
Title
Benzodiazepine derivatives. In Veterinary Pharmacology and Therapeutics
Study date
2018
Auth party contact address
-
Data no
275936
Title
Behavioural and glucocorticoid responses of dogs (Canis familiaris) to kennelling: investigating mitigation of stress by prior habituation
Study date
2007
Auth party contact address
-
Data no
275937
Title
Noise in dog kennelling: is barking a welfare problem for dogs?
Study date
1997
Auth party contact address
-
Data no
275938
Title
Chapter 38 Treatment of anxiety disorders. In Essentials of Clinical Psychopharmacology 3rd edition.
Study date
2013
Auth party contact address
-
Data no
275939
Title
Advances in Behavioral Psychopharmacology
Study date
2018
Auth party contact address
-
Data no
275940
Title
The biology of fear-and anxiety-related behaviors
Study date
2002
Auth party contact address
-
Data no
275941
Title
Clinical assessment of leukocytosis: distinguishing leukocytosis caused by inflammatory, glucocorticoid, physiology, and leukemic disorders or conditions
Study date
2003
Auth party contact address
-
Data no
275942
Title
Enhancing quality of life for dogs and cats in confined situations
Study date
2007
Auth party contact address
-
Data no
275943
Title
Chapter 21 Hypothalamus. In Fundamentals of Canine Neuroanatomy and Neurophysiology
Study date
2015
Auth party contact address
-
Data no
275944
Title
Human-animal bonds I: The relational significance of companion animals
Study date
2009
Auth party contact address
-
Data no
275961
Title
Pharmacology Report No. 15253
Study date
2016
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275871
Title
Response to D180 LoOI: Appendix 9-1
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275872
Title
Response to D180 LoOI: Appendix 9-2
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275873
Title
Response to D180 LoOI: Appendix 9-3
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275951
Title
Pharmacology
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275969
Title
Pharmacology Report No. 20139322
Study date
2018
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275970
Title
Pharmacology Report No. 20184090
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275971
Title
Pharmacology Report No. 20184153
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275972
Title
Pharmacology Report No. 100018458
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275973
Title
Pharmacology Report No. AB20500
Study date
2014
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275974
Title
Pharmacology Report No. AB20716
Study date
2015
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275980
Title
An analysis of exposure response data for pregabalin: A novel therapy for the treatment of diabetic neuropathic pain
Study date
2001
Auth party contact address
-
Data no
276019
Title
Pregabalin Influences Insula and Amygdala Activation During Anticipation of Emotional Images
Study date
2011
Auth party contact address
-
Data no
276020
Title
Gabapentin may inhibit synaptic transmission in the mouse spinal cord dorsal horn through a preferential block of P/Q-type Ca2+ channels
Study date
2004
Auth party contact address
-
Data no
276021
Title
Calcium channel alpha2-delta type 1 subunit is the major binding protein for pregabalin in neocortex, hippocampus, amygdala, and spinal cord: An ex vivo autoradiographic study in alpha2-delta type 1 genetically modified mice
Study date
2006
Auth party contact address
-
Data no
276022
Title
Alpha2delta ligands, gabapentin, pregabalin and mirogabalin: a review of their clinical pharmacology and therapeutic use
Study date
2016
Auth party contact address
-
Data no
276023
Title
Evidence that gabapentin reduces neuropathic pain by inhibiting the spinal release of glutamate
Study date
2005
Auth party contact address
-
Data no
276024
Title
Differential Distribution of Voltage-Gated Calcium Channel Alpha-2 Delta (a2g) Subunit mRNA-Containing Cells in the Rat Central Nervous System and the Dorsal Root Ganglia
Study date
2005
Auth party contact address
-
Data no
276025
Title
Voltage-gated calcium channels and their auxiliary subunits: physiology and pathophysiology and pharmacology
Study date
2016
Auth party contact address
-
Data no
276026
Title
Stimulus-Dependent Modulation of [3H]Norepinephrine Release from Rat Neocortical Slices by Gabapentin and Pregabalin
Study date
2000
Auth party contact address
-
Data no
276027
Title
Preferential Action of Gabapentin and Pregabalin at P/Q-Type Voltage-Sensitive Calcium Channels: Inhibition of K+-Evoked [3H]-Norepinephrine Release From Rat Neocortical Slices
Study date
2002
Auth party contact address
-
Data no
276028
Title
Pregabalin and gabapentin reduce release of substance P and CGRP from rat spinal tissues only after inflammation or activation of protein kinase C
Study date
2003
Auth party contact address
-
Data no
275963
Title
Pharmacology Report No. r19027
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275964
Title
Pharmacology Report No. r150331
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275991
Title
Prescribing information
Study date
2019
Auth party contact address
-
Data no
275999
Title
Pharmacokinetics of single-dose oral pregabalin administration in normal dogs
Study date
2009
Auth party contact address
-
Data no
276004
Title
Feeding Behaviour. In The Waltham Book of Dog and Cat Behaviour
Study date
1992
Auth party contact address
-
Data no
276007
Title
Pharmacokinetics of Single-Dose Oral Pregabalin Administration in Normal Cats
Study date
2018
Auth party contact address
-
Data no
276037
Title
Block by gabapentin of the facilitation of glutamate release from rat trigeminal nucleus following activation of protein kinase C or adenylyl cyclase
Study date
2001
Auth party contact address
-
Data no
276038
Title
Gabapentin inhibits the substance P-facilitated K1-evoked release of [3H]glutamate from rat caudal trigeminal nucleus slices
Study date
2001
Auth party contact address
-
Data no
276039
Title
Modulation of K+-induced synaptosomal calcium influx by gabapentin
Study date
2000
Auth party contact address
-
Data no
276040
Title
Elucidating the Mechanism of Action of Pregabalin
Study date
2012
Auth party contact address
-
Data no
276041
Title
Defensive-like behaviors induced by ultrasound: further pharmacological characterization in Lister-hooded rats
Study date
2007
Auth party contact address
-
Data no
276042
Title
Potent and stereospecific anticonvulsant activity of 3-isobutyl GABA relates to in vitro binding at a novel site labeled by tritiated gabapentin
Study date
1993
Auth party contact address
-
Data no
276030
Title
Inhibition of neuronal Ca2+ influx by gabapentin and subsequent reduction of neurotransmitter release from rat neocortical slices
Study date
2000
Auth party contact address
-
Data no
276031
Title
Inhibition of neuronal Ca2+ influx by gabapentin and pregabalin in the human neocortex
Study date
2002
Auth party contact address
-
Data no
276032
Title
Pregabalin: A Review of its Use in Adults with Generalized Anxiety Disorder
Study date
2014
Auth party contact address
-
Data no
276033
Title
Pregabalin is a potent and selective ligand for a2g-1 and a2g-2 calcium channel subunits
Study date
2014
Auth party contact address
-
Data no
276034
Title
Anxiolytic-Like Activity of Pregabalin in the Vogel Conflict Test in a2g-1 (R217A) and a2g-2 (R279A) Mouse Mutants
Study date
2011
Auth party contact address
-
Data no
276035
Title
Product monograph
Study date
2020
Auth party contact address
-
Data no
276002
Title
Activity profile of pregabalin in rodent models of epilepsy and ataxia
Study date
2006
Auth party contact address
-
Data no
276006
Title
Skin lesions following pregabalin administration in a cat
Study date
2017
Auth party contact address
-
Data no
275968
Title
Pharmacology Report No. 518193
Study date
2017
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
276106
Title
Safety Report No. 20305603
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275953
Title
Tolerance in target animal species
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275954
Title
Clinical
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275857
Title
Preemptive analgesia after lumbar spine surgery by pregabalin and celecoxib: a prospective study
Study date
2019
Auth party contact address
-
Data no
275858
Title
Clinical Presentation of Chiari-like Malformation in 2 Persian Cats
Study date
2020
Auth party contact address
-
Data no
275859
Title
Pregabalin for the treatment of generalised anxiety disorder
Study date
2006
Auth party contact address
-
Data no
275860
Title
Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability
Study date
2013
Auth party contact address
-
Data no
275861
Title
Pregabalin Has Analgesic, Ventilatory, and Cognitive Effects in Combination with Remifentanil
Study date
2016
Auth party contact address
-
Data no
275862
Title
Pregabalin: Its Efficacy, Safety and Tolerability Profile in Generalized Anxiety
Study date
2007
Auth party contact address
-
Data no
275863
Title
Risk of respiratory depression with opioids and concomitant gabapentinoids
Study date
2017
Auth party contact address
-
Data no
275864
Title
Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis
Study date
2019
Auth party contact address
-
Data no
275865
Title
Pregabalin alleviates clinical signs of syringomyeliarelated central neuropathic pain in Cavalier King Charles Spaniel dogs: a randomized controlled trial
Study date
2020
Auth party contact address
-
Data no
275866
Title
Preoperative oral pregabalin for anxiety control: a systematic review
Study date
2020
Auth party contact address
-
Data no
275867
Title
Drug safety evaluation of pregabalin
Study date
2012
Auth party contact address
-
Data no
275868
Title
Subjective, psychomotor, and physiological effects of pregabalin alone and in combination with oxycodone in healthy volunteers
Study date
2012
Auth party contact address
-
Data no
275845
Title
Effect of valproate and pregabalin on human anxiety-like behaviour in a randomised controlled trial
Study date
2018
Auth party contact address
-
Data no
275846
Title
Multi-trial Analysis of the Duration and Intensity of Adverse Effects Associated with Pregabalin Adjunctive Treatment of Partial Seizures
Study date
2005
Auth party contact address
-
Data no
275847
Title
How addictive are gabapentin and pregabalin? A systematic review
Study date
2017
Auth party contact address
-
Data no
275848
Title
Pharmacodynamic response profiles of anxiolytic and sedative drugs
Study date
2017
Auth party contact address
-
Data no
275849
Title
Suspected phenobarbital-induced fever in a cat
Study date
2019
Auth party contact address
-
Data no
275850
Title
Postoperative respiratory depression associated with pregabalin: A case series and a preoperative decision algorithm
Study date
2011
Auth party contact address
-
Data no
275851
Title
Long-term efficacy of pregabalin in generalized anxiety disorder
Study date
2008
Auth party contact address
-
Data no
275852
Title
Multimodal analgesia for treatment of allodynia and hyperalgesia after major trauma in a cat
Study date
2019
Auth party contact address
-
Data no
275853
Title
Pregabalin and the Risk for Opioid-Related Death: A Nested Case?Control Study
Study date
2018
Auth party contact address
-
Data no
275854
Title
Evaluation of clinical examination location on stress in cats: a randomized crossover trial
Study date
2020
Auth party contact address
-
Data no
275855
Title
Pregabalin poisoning and rising recreational use: a retrospective observational series
Study date
2020
Auth party contact address
-
Data no
275950
Title
Environmental risk assessment
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275830
Title
Bonqat_Internat Doc Summary - FINAL
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275831
Title
GMP certificates
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275869
Title
bonqat-responses-to-looi
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275834
Title
Bonqat - Cross-Reference Table - FINAL
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275835
Title
bonqat-responses-to-loq
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275821
Title
Project Plan - 141933
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275822
Title
PAA written assistance - 141933
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
277051
Title
EU Dossier
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275823
Title
Bonqat - D120 SO and LoQ
Study date
2020
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275824
Title
Bonqat - D180 SO and LoOI
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275825
Title
Bonqat Initial MA CVMP Assessment Report
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275826
Title
Bonqat II-0002-G - AR
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275827
Title
VRA 004 Assessment Report
Study date
2022
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275828
Title
VRA 005 Assessment Report
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275829
Title
SPC ema-bonqat-50-mg-ml-200223-en
Study date
2023
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275955
Title
Toxicology Report No. 784106
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275960
Title
Toxicology Report No. 20183660
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275995
Title
Injury to skeletal muscle of mice following acute and sub-acute pregabalin exposure
Study date
2017
Auth party contact address
-
Data no
275959
Title
Toxicology Report No. 20183658
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275958
Title
Toxicology Report No. 20183657
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275981
Title
Pregabalin Induces Hepatic Hypoxia and Increases Endothelial Cell Proliferation in Mice, a Process Inhibited by Dietary Vitamin E Supplementation
Study date
2012
Auth party contact address
-
Data no
275982
Title
Mode of Action Associated With Development of Hemangiosarcoma in Mice Given Pregabalin and Assessment of Human Relevance
Study date
2012
Auth party contact address
-
Data no
275983
Title
Key Components of the Mode of Action for Hemangiosarcoma Induction in Pregabalin-Treated Mice: Evidence of Increased Bicarbonate, Dysregulated Erythropoiesis, Macrophage Activation, and Increased Angiogenic Growth Factors in Mice but Not in Rats
Study date
2012
Auth party contact address
-
Data no
275997
Title
Hemangiosarcoma in Mice Administered Pregabalin: Analysis of Genotoxicity, Tumor Incidence, and Tumor Genetics
Study date
2012
Auth party contact address
-
Data no
275993
Title
Embryo-Fetal Developmental Toxicity Studies with Pregabalin in Mice and Rabbits
Study date
2016
Auth party contact address
-
Data no
275994
Title
Developmental Toxicity Studies with Pregabalin in Rats: Significance of Alterations in Skull Bone Morphology
Study date
2016
Auth party contact address
-
Data no
275956
Title
Toxicology Report No. 8406560
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275957
Title
Toxicology Report No. 8406561
Study date
2019
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275984
Title
Consideration of ethyl maltol and two 6-keto-1,4-dioxane derivatives substances evaluated by JECFA (65th meeting)
Study date
2010
Auth party contact address
-
Data no
275985
Title
Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives
Study date
2016
Auth party contact address
-
Data no
275986
Title
Efficacy and safety of premedication with single dose of oral pregabalin in children with dental anxiety: A randomized double-blind placebo-controlled crossover clinical trial
Study date
2015
Auth party contact address
-
Data no
275987
Title
Toxicological evaluation of some extraction solvents and certain other substances
Study date
1970
Auth party contact address
-
Data no
275988
Title
Toxicity studies with ethyl maltol
Study date
1969
Auth party contact address
-
Data no
275989
Title
Analgesic efficacy of pregabalin in acute postmastectomy pain: placebo controlled dose ranging study
Study date
2016
Auth party contact address
-
Data no
275975
Title
021446_3a5 References
Study date
2004
Auth party contact address
-
Data no
275976
Title
Clinical Pharmacokinetics of Pregabalin in Healthy Volunteers
Study date
2010
Auth party contact address
-
Data no
275945
Title
Precise identification of the product and its active substance(s)
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275946
Title
Pharmacology
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275947
Title
Toxicology
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275948
Title
Other requirements
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275949
Title
User risk assessment
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275996
Title
Handbook of Pharmaceutical Excipients 5th Edition
Study date
2005
Auth party contact address
-
Data no
276003
Title
The Effect of Pregabalin on Preoperative Anxiety and Sedation Levels: A Dose-Ranging Study
Study date
2009
Auth party contact address
-
Data no
279817
Title
Nonclinical Evaluation Report 1
Study date
2004
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
279818
Title
Nonclinical Evaluation Report 2
Study date
2006
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
275998
Title
Induction of hemangiosarcoma in mice after chronic treatment with S1P-modulator siponimod and its lack of relevance to rat and human
Study date
2018
Auth party contact address
-
Data no
276000
Title
Pregabalin Does Not Affect Sperm Production in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Noninferiority Study
Study date
2015
Auth party contact address
-
Data no
276001
Title
Drug safety evaluation of pregabalin
Study date
2012
Auth party contact address
-
Data no
275992
Title
Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: A phase 1,
randomized controlled study
randomized controlled study
Study date
2014
Auth party contact address
-
Data no
275977
Title
Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China
Study date
2019
Auth party contact address
-
Data no
275978
Title
Hemangiosarcoma in Rodents: Mode-of-Action Evaluation and Human Relevance
Study date
2009
Auth party contact address
-
Data no
275979
Title
Fenretinide, Troglitazone, and Elmiron Add to Weight of Evidence Support for Hemangiosarcoma Mode-of-Action From Studies in Mice
Study date
2018
Auth party contact address
-
Data no
275990
Title
The Pharmacokinetics of Pregabalin in Breast Milk, Plasma, and Urine of Healthy Postpartum Women
Study date
2016
Auth party contact address
-
Date
Application Date
Application No
Application Number
144782
Product/Active constituent Name
Application Product Name
Pest Controllers Own Fipronil 100 SC Termiticide & Insecticide
Application Date
Application Number
144782
Application Product Name
Pest Controllers Own Fipronil 100 SC Termiticide & Insecticide
Application details
Product name:
Pest Controllers Own Fipronil 100 SC Termiticide & Insecticide
Product number:
89141
Applicant Name:
AMGROW PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add additional uses.
Active constituents:
Active constituent name
58418 - FIPRONIL
Description of data provided:
Data no
274822
Title
GLOBE24001 REPORT FINAL 24MAY24
Study date
24/05/2024
Auth party contact address
UNIT B2A, 3/29 BIRNIE AVENUE LIDCOMBE Australia
Data no
274823
Title
GLOBE24001 DATA GREEN-HEAD ANT
Study date
24/05/2024
Auth party contact address
UNIT B2A, 3/29 BIRNIE AVENUE LIDCOMBE Australia
Data no
274824
Title
GLOBE24001 DATA MEAT ANT
Study date
24/05/2024
Auth party contact address
UNIT B2A, 3/29 BIRNIE AVENUE LIDCOMBE Australia
Data no
274825
Title
GLOBE24001 DATA BLACK HOUSE ANT
Study date
24/05/2024
Auth party contact address
UNIT B2A, 3/29 BIRNIE AVENUE LIDCOMBE Australia
Date
Application Date
Application No
Application Number
144862
Product/Active constituent Name
Application Product Name
FLUNIXIN MEGLUMINE
Application Date
Application Number
144862
Application Product Name
FLUNIXIN MEGLUMINE
Application details
Product name:
FLUNIXIN MEGLUMINE
Active name:
FLUNIXIN MEGLUMINE
Applicant Name:
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
Application purpose and description of use:
The purpose of this application is to seek approval of an existing active constituent, FLUNIXIN MEGLUMINE from a new source for use in veterinary chemical products.
Description of data provided:
Data no
275768
Title
Part 2 Chemistry - Vol 1 of 1.pdf Size (bytes): 10662365
Study date
July 2024
Auth party contact address
UNIT 7, 15-21 Butler Way TULLAMARINE Australia
Date
Application Date
Application No
Application Number
145029
Product/Active constituent Name
Application Product Name
Metacoxx KG Oral Suspension for Dogs
Application Date
Application Number
145029
Application Product Name
Metacoxx KG Oral Suspension for Dogs
Application details
Product name:
Metacoxx KG Oral Suspension for Dogs
Product number:
87621
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Variation of label approval to reword indication.
Active constituents:
Active constituent name
82924 - Meloxicam
Date
Application Date
Application No
Application Number
145122
Product/Active constituent Name
Application Product Name
EXIREL INSECTICIDE
Application Date
Application Number
145122
Application Product Name
EXIREL INSECTICIDE
Application details
Product name:
EXIREL INSECTICIDE
Product number:
64103
Applicant Name:
FMC AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration to allow a larger pack size than is currently registered.
Active constituents:
Active constituent name
66659 - CYANTRANILIPROLE
Date
Application Date
Application No
Application Number
145157
Product/Active constituent Name
Application Product Name
GENFARM 2,4-D B SELECTIVE HERBICIDE
Application Date
Application Number
145157
Application Product Name
GENFARM 2,4-D B SELECTIVE HERBICIDE
Application details
Product name:
GENFARM 2,4-D B SELECTIVE HERBICIDE
Product number:
88883
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
To vary the formulation.
Description of data provided:
Data no
277003
Title
Consent
Study date
19-Aug-2024
Auth party contact address
-