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
145552
Product/Active constituent Name
Application Product Name
ULTRAPHOS PHOSPHINE FUMIGANT
Application Date
Application Number
145552
Application Product Name
ULTRAPHOS PHOSPHINE FUMIGANT
Application details
Product name:
ULTRAPHOS PHOSPHINE FUMIGANT
Product number:
68499
Applicant Name:
SPECIALTY GASES PTY LTD
Application purpose and description of use:
Variation of product registration and/or label approval to update label statements..
Reference details:
51209 - VAPORPH3OS PHOSPHINE FUMIGANT
Active constituents:
Active constituent name
44115 - PHOSPHINE GAS
Date
Application Date
Application No
Application Number
145696
Product/Active constituent Name
Application Product Name
TYLOSIN BASE
Application Date
Application Number
145696
Application Product Name
TYLOSIN BASE
Application details
Product name:
TYLOSIN BASE
Active name:
TYLOSIN BASE
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Approval of Tylosin base for use in veterinary chemical products.
Description of data provided:
Data no
278743
Title
TYLOSIN BASE COA
Study date
SEP 24
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
145555
Product/Active constituent Name
Application Product Name
Globachem Abamectin 18 EC Insecticide
Application Date
Application Number
145555
Application Product Name
Globachem Abamectin 18 EC Insecticide
Application details
Product name:
Globachem Abamectin 18 EC Insecticide
Product number:
94817
Applicant Name:
Globachem n.v.
Application purpose and description of use:
Variation of product label approval to correct the rate in the control of mites in citrus to be 250 mL summer oil per 100 L.
Active constituents:
Active constituent name
52801 - ABAMECTIN
Active constituent name
44497 - ABAMECTIN
Active constituent name
48586 - ABAMECTIN
Active constituent name
50879 - ABAMECTIN
Active constituent name
53333 - ABAMECTIN
Active constituent name
69041 - ABAMECTIN
Description of data provided:
Data no
279016
Title
RE: INVITATION TO SUBMIT ITEM 13 APPLICATION
Study date
3 September 2024
Auth party contact address
Brustem Industriepark Lichtenberglaan 2019 Sint-Truiden Belgium
Date
Application Date
Application No
Application Number
145575
Product/Active constituent Name
Application Product Name
Glufonium 200 SL Herbicide
Application Date
Application Number
145575
Application Product Name
Glufonium 200 SL Herbicide
Application details
Product name:
Glufonium 200 SL Herbicide
Product number:
83334
Applicant Name:
SINON AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add uses from a reference product including the crops and uses: add blueberries, black currant, beans, pyrethrum, duboisia, date palms, green tea, native foods, sugarcane, fencelines, summer fallows, oil tea tree, nursery stock, foliage and cut flowers.
Reference details:
39118 - BASTA NON-SELECTIVE HERBICIDE
Active constituents:
Active constituent name
80555 - glufosinate-ammonium
Date
Application Date
Application No
Application Number
145550
Product/Active constituent Name
Application Product Name
Albaugh Durango Ultra 540K SL Herbicide
Application Date
Application Number
145550
Application Product Name
Albaugh Durango Ultra 540K SL Herbicide
Application details
Product name:
Albaugh Durango Ultra 540K SL Herbicide
Product number:
94473
Applicant Name:
ALBAUGH AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to vary registered particulars. Â
Active constituents:
Active constituent name
68365 - GLYPHOSATE
Active constituent name
85690 - Glyphosate
Description of data provided:
Data no
279244
Title
Active CoAs
Study date
Aug 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279243
Title
Manufacturing process
Study date
Aug 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279240
Title
Part 2 Chemistry Dossier
Study date
Aug 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279241
Title
SDSs
Study date
March 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279242
Title
Physico Chem & Stability Report
Study date
June 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279245
Title
Part 8 Efficacy Dossier
Study date
Aug 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279246
Title
Bioequivalency Report 1
Study date
Aug 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279247
Title
Bioequivalency Report 2
Study date
Aug 2024
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
279239
Title
Executive summary
Study date
Aug 24
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
145705
Product/Active constituent Name
Application Product Name
TITAN GLUFOSINATE 200 HERBICIDE
Application Date
Application Number
145705
Application Product Name
TITAN GLUFOSINATE 200 HERBICIDE
Application details
Product name:
TITAN GLUFOSINATE 200 HERBICIDE
Product number:
66364
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of label approval to extend the label claim of Titan Glufosinate 200 Herbicide (66364) for over-the-top (OTT) application to XtendFlex cotton and for use in summer fallow.
Reference details:
62489 - BIFFO NON-SELECTIVE HERBICIDE
62489 - Nufarm Biffo Herbicide
Active constituents:
Active constituent name
61903 - GLUFOSINATE-AMMONIUM
Description of data provided:
Data no
279020
Title
Application Summary: Variation of Titan Glufosinate 200 Herbicide (66364)
Study date
9 October 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279024
Title
BIOEQUIVALENCE OF TITAN GLUFOSINATE 200 WITH BIFFO WHEN APPLIED SINGLY OR IN SEQUENCE WITH GLUFOSINATE OR TITAN CC & DRY OTT GLY 700 IN XTEND FLEX COTTON
Study date
15 August 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279025
Title
Trial ??? Titan Glufosinate 200 Bioequivalence to Biffo in Xtendflex Cotton
Study date
February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279026
Title
BIOEQUIVALENCE OF TITAN GLUFOSINATE 200 WITH BIFFO WHEN APPLIED SINGLY OR IN SEQUENCE WITH GLUFOSINATE OR TITAN TITANIUM 570 IN XTEND FLEX COTTON
Study date
20 August 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279027
Title
Trial ??? Titan Glufosinate 200 Bioequivalence to Biffo in Xtendflex Cotton
Study date
February 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279028
Title
BIOEQUIVALENCE OF TITAN GLUFOSINATE 200 WITH BIFFO IN SEQUENTIAL PROGRAM WITH TITAN CC & DRY OTT GLY 700 FOR THE CONTROL OF ANNUAL WEEDS IN FALLOW
Study date
15 August 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279029
Title
BIOEQUIVALENCE OF TITAN GLUFOSINATE 200 WITH BIFFO IN SEQUENTIAL PROGRAM WITH TITAN TITANIUM 570 FOR THE CONTROL OF ANNUAL WEEDS IN FALLOW
Study date
15 August 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279021
Title
Pre-application assistance (PAA) ??? APVMA written assistance
Study date
4 July 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279018
Title
66364 AA letter
Study date
9 October 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279019
Title
Titan Glufosinate 200 Herbicide PAA advice comments
Study date
9 October 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279022
Title
To determine the residues of glufosinate in XtendFlex Cotton (field phase)
Study date
16 September 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
279023
Title
To determine the residues of glufosinate in XtendFlex Cotton (analytical phase)
Study date
9 September 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
145573
Product/Active constituent Name
Application Product Name
Ketoprofen V Injection for Cattle and Horses
Application Date
Application Number
145573
Application Product Name
Ketoprofen V Injection for Cattle and Horses
Application details
Product name:
Ketoprofen V Injection for Cattle and Horses
Product number:
82151
Applicant Name:
AVET HEALTH LIMITED
Application purpose and description of use:
Variation of product registration and label approval to vary product particulars and to update label to be in line with the Veterinary Labelling Code.
Active constituents:
Active constituent name
84311 - KETOPROFEN
Description of data provided:
Data no
278458
Title
GMP
Study date
2022
Auth party contact address
-
Date
Application Date
Application No
Application Number
145426
Product/Active constituent Name
Application Product Name
VERSYS INSECTICIDE
Application Date
Application Number
145426
Application Product Name
VERSYS INSECTICIDE
Application details
Product name:
VERSYS INSECTICIDE
Product number:
82738
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Variation of product registration and label approval for extension of use into apple and pear. This application includes uses that, if granted, may trigger an extension to the limitation period.
Active constituents:
Active constituent name
82739 - AFIDOPYROPEN
Description of data provided:
Data no
278695
Title
Evaluate the efficacy and the most effective rate of BAS 440 00I on the control of Apple Dimpling Bug
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278696
Title
Evaluation the efficacy of BAS 550 UGI and BAS 440 00I insecticide for the control of long tailed mealybugs in pear
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278697
Title
Evaluation the efficacy of BAS 550UGI and BAS 440 00I insecticide for the control of long tailed mealybugs in pear
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278698
Title
Efficacy of BAS 440 00I 100 DC for apple dimpling bug (Campylomma liebknechti) control in apples cv. Red Delicious
Study date
2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278699
Title
Comparison of BAS 440 00I 100 DC +/- Agral 600 SL with Calypso 480 SC for the control of apple dimpling bug (Campylomma liebknechti) and western flower thrips (Frankliniella occidentalis) in apples cv. Smitten
Study date
2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278700
Title
BAS 440I/apple/dimpling bug control
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278701
Title
Evaluate the efficacy of BAS 440 00I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278702
Title
Evaluate the efficacy of BAS 440 00I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278703
Title
BAS 550I/apple/dimpling bug control
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278704
Title
Evaluate the efficacy of BAS 550 01I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278705
Title
Evaluate the efficacy of BAS 550 01I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278706
Title
Efficacy of BAS 55001I at Controlling Long Tailed Mealybugs in a Pear Orchard
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278707
Title
Comparison of BAS 550 01I 120 SL +/- BAS 440 00I 100 DC or BAS 480 03I 76.8 OD, BAS 440 00I and BAS 480 03I 76.8 with Calypso 480 SC for the control of apple dimpling bug (Campylomma liebknechti) in pears cv. Packham?s Triumph
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278708
Title
Evaluate the efficacy of BAS 5500I on the control of Apple Dimpling Bug
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278709
Title
Trial Reference: NAS-WA-23-DB-I06
Study date
2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278710
Title
Part 8 Effiacy & Crop Safety Dossier Summary
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278711
Title
Determination of residues of BAS440 in pome fruit following four foliar applications of BAS 440 00 I Australia 2022-2023
Study date
October 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278712
Title
Determination of residues of afidopyropen in pome fruit following four foliar applications of BAS 440 00 I
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278715
Title
Evaluation of Processed Food/Feed (PF) Residues of BAS 440 I in Appl
Study date
2016
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278713
Title
Part 5B Residues Trade Summary Dossier
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278714
Title
Part 5A Residues Summary Dossier
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
145310
Product/Active constituent Name
Application Product Name
Daxocox 30mg tablets for dogs
Application Date
Application Number
145310
Application Product Name
Daxocox 30mg tablets for dogs
Application details
Product name:
Daxocox 30mg tablets for dogs
Product number:
95333
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 30mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Date
Application Date
Application No
Application Number
145565
Product/Active constituent Name
Application Product Name
GENFARM DIURON 900WG HERBICIDE
Application Date
Application Number
145565
Application Product Name
GENFARM DIURON 900WG HERBICIDE
Application details
Product name:
GENFARM DIURON 900WG HERBICIDE
Product number:
60286
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation of product registration to add an alternative formulation.
Reference details:
66636 - WYNCA DIURON 900 WG HERBICIDE
Active constituents:
Active constituent name
56728 - DIURON
Active constituent name
44484 - DIURON
Date
Application Date
Application No
Application Number
145574
Product/Active constituent Name
Application Product Name
GENFARM S-METOLACHLOR 960 HERBICIDE
Application Date
Application Number
145574
Application Product Name
GENFARM S-METOLACHLOR 960 HERBICIDE
Application details
Product name:
GENFARM S-METOLACHLOR 960 HERBICIDE
Product number:
69136
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation to formulation
Active constituents:
Active constituent name
44437 - S-METOLACHLOR
Active constituent name
67054 - S-METOLACHLOR
Active constituent name
67246 - S-METOLACHLOR
Active constituent name
69340 - S-METOLACHLOR
Description of data provided:
Data no
279401
Title
Support
Study date
2024
Date
Application Date
Application No
Application Number
145556
Product/Active constituent Name
Application Product Name
X-VERMINATOR SINGLE FEED LETHAL DOSE RODENT BLOCKS
Application Date
Application Number
145556
Application Product Name
X-VERMINATOR SINGLE FEED LETHAL DOSE RODENT BLOCKS
Application details
Product name:
X-VERMINATOR SINGLE FEED LETHAL DOSE RODENT BLOCKS
Product number:
63624
Applicant Name:
ANIMAL CONTROL PRODUCTS LTD
Application purpose and description of use:
Variation of product registration and label approval to vary the pack size.
Active constituents:
Active constituent name
56139 - BRODIFACOUM
Description of data provided:
Data no
279369
Title
Part 2.4
Study date
24 September 2024
Data no
279370
Title
Report T8273: Analysis Report Stability Study Part 1
Study date
20 September, 2023
Data no
279371
Title
Report T8327: Analysis Report Stability Study Part 2
Study date
20 November, 2023
Date
Application Date
Application No
Application Number
145578
Product/Active constituent Name
Application Product Name
Porcilis Lawsonia Inactivated Vaccine for Pigs
Application Date
Application Number
145578
Application Product Name
Porcilis Lawsonia Inactivated Vaccine for Pigs
Application details
Product name:
Porcilis Lawsonia Inactivated Vaccine for Pigs
Product number:
91351
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update side effects section.
Active constituents:
Active constituent name
91350 - Lawsonia intracellularis strain SPAH-08
Description of data provided:
Data no
278460
Title
PSUR assessment report
Study date
2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
145008
Product/Active constituent Name
Application Product Name
Arbor Spray E15 Emamectin Tree Injection
Application Date
Application Number
145008
Application Product Name
Arbor Spray E15 Emamectin Tree Injection
Application details
Product name:
Arbor Spray E15 Emamectin Tree Injection
Product number:
95218
Applicant Name:
Arbor Spray Pty Ltd
Application purpose and description of use:
Registration of a 15 g/L EMAMECTIN BENZOATE liquid formulation, a ready to use liquid formulation for use via trunk or stem injection for the control of Elm Leaf Beetle.
Reference details:
88692 - EMA-JECT RTU TREE INJECTABLE INSECTICIDE
Active constituents:
Active constituent name
69065 - EMAMECTIN BENZOATE
Description of data provided:
Data no
276648
Title
Emamectin Benzoate - CoAl
Study date
28 February 2023
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276647
Title
Method Validation for the determination of emamectin benzoate* in Emamectin benzoate Tree Injectable RTU
Study date
23 April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276649
Title
Part 2 - Chemistry & Manufacture
Study date
April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276650
Title
The Formulation of an Emamectin Benzoate RTU Tree Injectable Insecticide
Study date
April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276651
Title
Excipient SDSs
Study date
April 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276654
Title
Part 8 - Efficacy & Crop Safety
Study date
August 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276655
Title
Evaluation of Arbor Spray E15 Emamectin Tree Injection for the Control of Elm Leaf Beetle (Pyrrahalta luteola) in Elm trees
Study date
15 February 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276656
Title
Evaluation of Arbor Spray E15 Emamectin Tree Injection for the Control of Elm Leaf Beetle (Pyrrahalta luteola) in Elm trees
Study date
20 February 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276652
Title
Part 3 - Heath
Study date
July 2024
Auth party contact address
21 Albert Rd Drouin Australia
Data no
276653
Title
SDS - Arbor Spray E15 Emamectin Tree Injection
Study date
July 2024
Auth party contact address
21 Albert Rd Drouin Australia
Date
Application Date
Application No
Application Number
145359
Product/Active constituent Name
Application Product Name
Sabakem Clethodim 360EC
Application Date
Application Number
145359
Application Product Name
Sabakem Clethodim 360EC
Application details
Product name:
Sabakem Clethodim 360EC
Product number:
93184
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Variation of product registration to add formulation site and additional formulation.
Reference details:
87593 - Spalding Clethodim 360 EC Herbicide
Active constituents:
Active constituent name
66831 - CLETHODIM
Description of data provided:
Data no
279368
Title
Consent for use Protected Information Sabakem Clethodim 360EC (93184)
Study date
20 August 2024
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date
Application Date
Application No
Application Number
145553
Product/Active constituent Name
Application Product Name
Surefire Zinam 500 SC Fungicide
Application Date
Application Number
145553
Application Product Name
Surefire Zinam 500 SC Fungicide
Application details
Product name:
Surefire Zinam 500 SC Fungicide
Product number:
85676
Applicant Name:
PCT HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to include additional uses in turf.
Active constituents:
Active constituent name
68026 - FLUAZINAM
Description of data provided:
Data no
279353
Title
Evaluation of PCT Surefire Zinam Fungicide for pythium plant disease and algae control in Turfgrass.
Study date
27/08/2024
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Data no
279354
Title
Quali-Pro Compass Fungicide (82613/138194)
Study date
20/6/2023
Auth party contact address
-
Data no
279355
Title
Part 8 Summary
Study date
September 2024
Auth party contact address
UNIT 5, NO. 74 MURDOCH CIRCUIT ACACIA RIDGE Australia
Date
Application Date
Application No
Application Number
145561
Product/Active constituent Name
Application Product Name
ABBEY TIAMULIN 50 PREMIX
Application Date
Application Number
145561
Application Product Name
ABBEY TIAMULIN 50 PREMIX
Application details
Product name:
ABBEY TIAMULIN 50 PREMIX
Product number:
95416
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Registration of a 50g/Kg Tiamulin Hydrogen Fumarate product for ABBEY TIAMULIN 50 PREMIX
Reference details:
67671 - TIAMULIN 50 MILL PACK
Active constituents:
Active constituent name
82709 - TIAMULIN HYDROGEN FUMARATE
Active constituent name
84120 - TIAMULIN HYDROGEN FUMARATE
Description of data provided:
Data no
279014
Title
Abbey Tiamulin Product specs V1SEP24
Study date
Sep 24
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
145456
Product/Active constituent Name
Application Product Name
MILBEMAX TABLETS FOR SMALL CATS
Application Date
Application Number
145456
Application Product Name
MILBEMAX TABLETS FOR SMALL CATS
Application details
Product name:
MILBEMAX TABLETS FOR SMALL CATS
Product number:
54264
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Description of data provided:
Data no
278433
Title
Chemistry, Pharmacology and Safety: Milbemyin Oxime
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278434
Title
RLPs
Study date
2024
Auth party contact address
-
Data no
278432
Title
Companion Animal Zoonoses Guidelines
Study date
2024
Auth party contact address
is supported by Boehringer Ingelheim Animal Health
Date
Application Date
Application No
Application Number
145457
Product/Active constituent Name
Application Product Name
MILBEMAX TABLETS FOR CATS
Application Date
Application Number
145457
Application Product Name
MILBEMAX TABLETS FOR CATS
Application details
Product name:
MILBEMAX TABLETS FOR CATS
Product number:
54265
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Date
Application Date
Application No
Application Number
145309
Product/Active constituent Name
Application Product Name
Daxocox 15mg tablets for dogs
Application Date
Application Number
145309
Application Product Name
Daxocox 15mg tablets for dogs
Application details
Product name:
Daxocox 15mg tablets for dogs
Product number:
95332
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 15mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Description of data provided:
Data no
277501
Title
Certificates of Analysis
Study date
2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277485
Title
Chemistry and Manufacture Summary Product
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277491
Title
Certificate of GMP
Study date
Dec 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277492
Title
Certificate of GMP
Study date
June 2022
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277493
Title
Quality Documentation Part 2A Qualitative Particulars
Study date
January 2021
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277494
Title
Quality Documentation Part 2B Manufacture
Study date
December 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277496
Title
Quality Documentation Part 2C2 Starting Materials
Study date
February 2021
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277497
Title
Quality Documentation Part 2C4 Starting Materials
Study date
December 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277500
Title
Quality Documentation Part 2E Finished Product Tests
Study date
November 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
278365
Title
GMP Certificate 2023
Study date
2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277498
Title
Quality Documentation Part 2D Control Tests
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277499
Title
Quality Documentation Part 2G Other Information
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277495
Title
Appendic 2B.3-1
Study date
June 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277503
Title
Quality Documentation Part 2C3 Packaging
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277504
Title
Certificates of Analysis
Study date
January 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277505
Title
Detailed and Critical Summary on the Pharmaceutical Documentation
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277502
Title
Quality Documentation Part 2F2 Stability Finished Product
Study date
October 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277486
Title
Efficacy and Safety Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277488
Title
Efficacy Data
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277604
Title
Report EV-18/18
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277605
Title
Comparison of oral robenacoxib and carprofen for the treatment of osteoarthritis in dogs: a randomised clinical trial
Study date
2012
Auth party contact address
-
Data no
277606
Title
Pharmacokinetics, pharmacodynamics, toxicology and therapeutics of mavacoxib in the dog: a review
Study date
2014
Auth party contact address
-
Data no
277587
Title
Systematic review of the management of canine osteoarthritis
Study date
2009
Auth party contact address
-
Data no
277588
Title
Use of non-steroidal anti-inflammatory drugs for the treatment of canine osteoarthritis
Study date
2010
Auth party contact address
-
Data no
277589
Title
A pharmacokinetic / pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog
Study date
2001
Auth party contact address
-
Data no
277590
Title
Report BM-12/09-SN
Study date
April 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277591
Title
Report BM-12/10-SN
Study date
May 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277592
Title
Report BM-10/28
Study date
October 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277593
Title
Report BM-13/06-SN
Study date
May 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277594
Title
Report EV-013/09-SN
Study date
December 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277595
Title
Report PK_001_2018
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277596
Title
Report DA/184/C
Study date
January 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277597
Title
Report BM-14/20
Study date
October 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277598
Title
Report DA/197/C
Study date
December 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277599
Title
Report BM-16/39
Study date
October 2017
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277600
Title
Report PK_001_2019
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277601
Title
Report PK_001_2020
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277602
Title
Report ONDAX (DA/184/C and DA/197/C)
Study date
July 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277603
Title
Report EV-19/01-SN
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277570
Title
Report CD-99/6639T
Study date
December 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277571
Title
Report CD-99/6640T
Study date
December 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277572
Title
Report CD-98/6369T
Study date
May 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277573
Title
Report T-13/02
Study date
May 2015
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277574
Title
Report T-98/07
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277575
Title
Report T-98/08
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277576
Title
Report T-13/01
Study date
April 2015
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277578
Title
Report CD-98/6397FD
Study date
March 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277579
Title
Report CD-98/6396FD
Study date
February 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277580
Title
Report CD-98/6398FD
Study date
February 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277581
Title
Report CD-99/6507FD
Study date
April 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277582
Title
Report 0538/051-D6146
Study date
July 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277583
Title
Report 123119
Study date
December 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277584
Title
Report 123219
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277585
Title
Report 123019
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277586
Title
Report 136720
Study date
July 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277607
Title
CVMP assessment report for Daxocox (EMEA/V/C/005354/0000)
Study date
April 2021
Auth party contact address
-
Data no
277535
Title
Report BM-00/02
Study date
April 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277528
Title
Report BM-12/13
Study date
June 2014
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277530
Title
Report BM-98/20
Study date
May 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277532
Title
Report BM-99/03
Study date
July 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277537
Title
Report BM-01/24
Study date
August 2004
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277538
Title
Report BM-01/31-SN
Study date
April 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277539
Title
Report BM-01/20
Study date
December 2004
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277540
Title
Chirality, 16: 302-308
Study date
2004
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277546
Title
Report A186725
Study date
May 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277547
Title
Report BM-98/22
Study date
July 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277556
Title
Report BM-00/09
Study date
March 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277557
Title
Report BM-99/15
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277558
Title
Report CD-98/6399FD
Study date
February 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277559
Title
Report BM-99/30-SN
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277560
Title
Report T-98/05
Study date
February 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277561
Title
Report T-99/04
Study date
December 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277562
Title
Report T-98/06
Study date
January 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277563
Title
Report T-99/05
Study date
March 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277564
Title
Report T-99/03
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277565
Title
Report CD-98/6358T
Study date
December 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277566
Title
Report T-00/08
Study date
March 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277567
Title
Report CD-98/6359T
Study date
September 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277568
Title
Report CD-98/6360T
Study date
January 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277548
Title
Report BM-00/11
Study date
October 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277549
Title
Report 118419
Study date
November 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277550
Title
Report BM-00/29-SN
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277551
Title
Report AT18P2501-01
Study date
January 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277552
Title
Report 113518
Study date
November 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277553
Title
Report BM-99/08
Study date
June 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277554
Title
Report CD-98/6361FD
Study date
December 1998
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277555
Title
Report BM-00/16
Study date
March 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277541
Title
Report CD-98/6419FC
Study date
January 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277542
Title
Report BM-99/16
Study date
April 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277543
Title
Report BM-10/24-SN
Study date
October 2011
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277544
Title
Report S27766
Study date
July 2010
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277545
Title
Report TH180077
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277533
Title
Report BM-00/01-SN
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277534
Title
Report BM-00/17
Study date
September 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277531
Title
Report BM-99-06-SN
Study date
October 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277529
Title
Report BM-98/21
Study date
June 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277506
Title
Report AI-99/01-SN
Study date
October 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277507
Title
Report FBIO-01/01-SN
Study date
October 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277508
Title
Report SNEC-13/11-SN
Study date
May 2014
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277509
Title
Report 284110
Study date
February 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277510
Title
Report S40772
Study date
October 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277511
Title
Report AI 99/06-SN
Study date
May 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277512
Title
Report AI-99/12-SN
Study date
September 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277513
Title
Report SNEC-13/12-SN
Study date
May 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277514
Title
Report AI-99/13-SN
Study date
May 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277515
Title
Report AI-99/04-SN
Study date
January 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277516
Title
Report AI-99/03-SN
Study date
June 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277517
Title
Report AI-99/07-SN
Study date
March 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277518
Title
Report FI-00/01-SN
Study date
January 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277519
Title
Report A113483
Study date
October 2012
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277520
Title
Report A123936
Study date
December 2012
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277521
Title
Report BM-99/19-SN
Study date
February 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277522
Title
Report BM-01/16-SN
Study date
February 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277523
Title
Report BM-01/18-SN
Study date
March 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277524
Title
Report 111018
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277525
Title
Report 112318
Study date
October 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277526
Title
Report 112218
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277527
Title
Report BM-12/14
Study date
June 2014
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277536
Title
Report CRO-PK-01-48
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277577
Title
Report CD-98/6393FD
Study date
March 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277487
Title
Safety Data
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277569
Title
Report VX05LK
Study date
September 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277490
Title
Environment Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277609
Title
ENVIRONMENTAL IMPACT ASSESSMENT (EIAS) FOR VETERINARY MEDICINAL PRODUCTS (VMPS) - PHASE I
Study date
June 2000
Auth party contact address
-
Data no
277483
Title
Cover Letter
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277484
Title
Application Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277611
Title
Summary of Product Characteristics
Study date
February 2021
Auth party contact address
-
Data no
277610
Title
Summary of Opinion
Study date
February 2021
Auth party contact address
-
Data no
277608
Title
Safety Data Sheet
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277489
Title
Health Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia