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

144578
Product/Active constituent Name

Application Product Name

PHOSIC 600 SYSTEMIC FUNGICIDE

Application details

Product name:

PHOSIC 600 SYSTEMIC FUNGICIDE

Product number:

62941

Applicant Name:

S.J.B. AG-NUTRI PTY. LTD.

Application purpose and description of use:

Variation of the label only:

Active constituents:

Active constituent name
61284 - PHOSPHONIC ACID
Date

Application Date

Application No

Application Number

144598
Product/Active constituent Name

Application Product Name

[Wagg & Purr] Carprofen 75 mg Chewable Tablets for Dogs

Application details

Product name:

[Wagg & Purr] Carprofen 75 mg Chewable Tablets for Dogs

Product number:

95078

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of a 75 mg carpforen chewable tablet product for used as a non-steroidal anti-inflammatory drug (NSAID) in dogs.

Reference details:

52469 - RIMADYL 75MG CHEWABLE TABLETS FOR DOGS

Active constituents:

Active constituent name
95072 - Carprofen

Description of data provided:

Data no
273846
Author
Anon
Title
Product specifications 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273847
Author
Anon
Title
Product specifications 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Date

Application Date

Application No

Application Number

144599
Product/Active constituent Name

Application Product Name

[Wagg & Purr] Carprofen 25 mg Chewable Tablets for Dogs

Application details

Product name:

[Wagg & Purr] Carprofen 25 mg Chewable Tablets for Dogs

Product number:

95079

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of a 25 mg carpforen chewable tablet product for used as a non-steroidal anti-inflammatory drug (NSAID) in dogs.

Reference details:

52468 - RIMADYL 25MG CHEWABLE TABLETS FOR DOGS

Active constituents:

Active constituent name
95072 - Carprofen

Description of data provided:

Data no
273848
Author
Anon
Title
Product specifications 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273849
Author
Anon
Title
Product specifications 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Date

Application Date

Application No

Application Number

144590
Product/Active constituent Name

Application Product Name

Carprofen

Application details

Product name:

Carprofen

Active name:

Carprofen

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

New source of pharmacopoeia active constituent.

Description of data provided:

Data no
275658
Author
Anon
Title
Active certificates of analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 4 24-28 Collins Street MELBOURNE Australia
Date

Application Date

Application No

Application Number

144895
Product/Active constituent Name

Application Product Name

Cyproconazole

Application details

Product name:

Cyproconazole

Active name:

Cyproconazole

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of Cyproconazole for use in agricultural products.

Description of data provided:

Data no
275817
Author
Mink, C./Gahler B.
Title
Determination of Cyproconazole tech. by HPLC - Analytical Method SA-166/1
Study date
05 October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275818
Author
Mink, C.
Title
Cyproconazole tech - Determination of By-Products and Supplementary Tests by UHPLC and Capillary Gas Chromatography
Study date
05 October 2020
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275816
Author
Herdlitschka, A.
Title
Cyproconazole- Analysis of Five Representative Batches
Study date
07 March 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275814
Author
Vergura, S.
Title
CYPROCONAZOLE - MANUFACTURING PROCESS
Study date
10 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275815
Author
Nayyar, P.
Title
Declaration of Composition
Study date
25 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275819
Author
Mink, C.
Title
Cyproconazole ??? Validation of Analytical Method SA-166/1
Study date
28 Feb 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275820
Author
Mink, C.
Title
Cyproconazole ??? Validation of Analytical Method SB-166/1
Study date
27 September 2018
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275811
Author
Nayyar, P.
Title
Part 2 - Chemistry and Manufacture
Study date
30 July 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275812
Author
Mink, C.
Title
Statement on UV wavelength screening of Cyproconazole by Diodearray
Study date
20 January 2021
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
275813
Author
Heintz, K.
Title
Cyproconazole - Identification of Cyproconazole and its Impurities in Five Representative Batches
Study date
14 June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

144589
Product/Active constituent Name

Application Product Name

[Wagg & Purr] Carprofen 100 mg Chewable Tablets for Dogs

Application details

Product name:

[Wagg & Purr] Carprofen 100 mg Chewable Tablets for Dogs

Product number:

95071

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of a 100 mg carprofen chewable tablet product for use as a non-steroidal anti-inflammatory drug (NSAID) in dogs.

Reference details:

52470 - RIMADYL 100MG CHEWABLE TABLETS FOR DOGS

Active constituents:

Active constituent name
95072 - Carprofen

Description of data provided:

Data no
273821
Author
Anon
Title
Analytical method report 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273822
Author
Anon
Title
Analytical method report 2
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273823
Author
Anon
Title
Analytical method report 3
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273824
Author
Anon
Title
Analytical method report 4
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273825
Author
Anon
Title
Analytical validation report 1
Study date
2019
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273826
Author
Anon
Title
Analytical validation protocol and report 2
Study date
2019
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273827
Author
Anon
Title
Analytical validation protocol and report 3
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273818
Author
Anon
Title
Certificate of analysis 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273819
Author
Anon
Title
Certificate of analysis 2
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273820
Author
Anon
Title
Certificate of analysis 3
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273815
Author
Anon
Title
Product specifications 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273816
Author
Anon
Title
Product specifications 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273817
Author
Anon
Title
Product specifications justification
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
286238
Author
Anon
Title
Product specifications justification data
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
286239
Author
Anon
Title
Monograph
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
273797
Author
Anon
Title
Excipients certificates of analysis
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273798
Author
Anon
Title
Excipient 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273799
Author
Anon
Title
Excipient 2
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273800
Author
Anon
Title
Manufacturing flowchart
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273801
Author
Anon
Title
Manufacturing description
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273802
Author
Anon
Title
Process validation protocol
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273803
Author
Anon
Title
Process validation report
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273804
Author
Anon
Title
Process validation packaging report 1
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273805
Author
Anon
Title
Process validation packaging report 2
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273806
Author
Anon
Title
Process validation packaging report 3
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273807
Author
Anon
Title
Process validation packaging report 4
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273808
Author
Anon
Title
Process validation packaging report 5
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273809
Author
Anon
Title
Process validation packaging report 6
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273810
Author
Anon
Title
In process controls
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273811
Author
Anon
Title
Process validation protocol
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273812
Author
Anon
Title
Process validation report
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273813
Author
Anon
Title
Packaging 1
Study date
2018
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273814
Author
Anon
Title
Packaging 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
286240
Author
Anon
Title
Explanation letter
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
293437
Author
Anon
Title
Explanation letter
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273843
Author
Anon
Title
Efficacy study 4
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
286235
Author
Anon
Title
Excipient 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
286236
Author
Anon
Title
Excipient 2
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273795
Author
Anon
Title
Part 2 dossier
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273828
Author
Anon
Title
Stability report 1
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273829
Author
Anon
Title
Stability report 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273830
Author
Anon
Title
Stability report 3
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273831
Author
Anon
Title
Stability report 4
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273832
Author
Anon
Title
Stability report 5
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273833
Author
Anon
Title
Stability report 6
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273834
Author
Anon
Title
Stability report 7
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273840
Author
Anon
Title
Efficacy study 1
Study date
2018
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273841
Author
Anon
Title
Efficacy study 2
Study date
2017
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273842
Author
Anon
Title
Efficacy study 3
Study date
2018
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
286237
Author
Anon
Title
ICH M13B Guideline
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
273835
Author
Anon
Title
Part 8 Efficacy and Safety dossier
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273836
Author
Anon
Title
Pharmacology
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273837
Author
Sheskey PJ et al
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
273838
Author
Anon
Title
Excipient 1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273839
Author
Anon
Title
Excipient 2
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273789
Author
Anon
Title
GMP certificate 1
Study date
2022
Authorising party
Public
Auth party contact address
-
Data no
273790
Author
Anon
Title
GMP report redacted 1
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273791
Author
Anon
Title
GMP report 1
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273792
Author
Anon
Title
GMP certificate 2
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
273793
Author
Anon
Title
GMP report redacted 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
273794
Author
Anon
Title
GMP report 2
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Date

Application Date

Application No

Application Number

144595
Product/Active constituent Name

Application Product Name

Flg22-Bt Peptide

Application details

Product name:

Flg22-Bt Peptide

Product number:

95075

Applicant Name:

ELEMENTAL ENZYMES AUSTRALIA PTY LTD

Application purpose and description of use:

Item 2 application for approval of new active constituent Flg22-Bt Peptide and registration of formulated product Vismax Specialty 95076/144596.

Description of data provided:

Data no
274272
Author
Jami Larson
Title
Five Batch Analysis of Flg22-Bt Peptide Technical
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274273
Author
Jami Larson
Title
Five Batch Analysis of Flg22-Bt Peptide Technical
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274274
Author
Klasek and Leslie
Title
Addendum_Flg22-BtPeptideTechnical_5BatchAnalysis
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274270
Author
Leslie et al
Title
Flg22Bt-PeptideTechnical_MFGProcess
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274271
Author
Various
Title
Flg22Bt-PeptideTechnical_MFGProcess - SDS raw materials
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
274275
Author
Anon
Title
COA's for Active
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274276
Author
Dr Sharon Gossage
Title
Declaration of Composition_Active
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274277
Author
APVMA
Title
VISMAX Specialty Crops - chemistry report for active
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274278
Author
Anon
Title
Flg22-BtPeptideTechnical_Elemental Analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274279
Author
Dr Sharon Gossage
Title
Email to APVMA_LOQ_LOD
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274280
Author
APVMA
Title
APVMA response_LOD_LOQ
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274262
Author
Desai
Title
TGAI Appearance
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274263
Author
Desai
Title
TGAI Melting point
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274264
Author
Desai
Title
TGAI pH
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274265
Author
Desai
Title
TGAI Bulk Density
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274266
Author
Desai
Title
TGAI Partition Coefficient
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274267
Author
Desai
Title
TGAI Water Solubility
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274268
Author
Desai
Title
TGAI Organic Solvent Solubility
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274269
Author
Desai
Title
TGAI UV Visible Absorption
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274261
Author
Dr Sharon Gossage
Title
PART 2 CHEMISTRY & MANUFACTURE
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274285
Author
Mhaske
Title
Flg22-BtPeptideTechnical_AcuteDermalIrritationRabbit
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274282
Author
Verma
Title
Flg22-BtPeptideTechnical_AcuteDermalToxicityRat
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274283
Author
Verma
Title
Flg22-BtPeptideTechnical_AcuteInhalationToxicityRat
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274281
Author
Verma
Title
Flg22-BtPeptideTechnical_AcuteOralToxicityRat
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274284
Author
Mhaske
Title
Flg22-BtPeptideTechnical_AcuteDermalIrritationRabbit
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274286
Author
Mhaske
Title
Flg22-BtPeptideTechnical_LLNASkinSensitization
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Date

Application Date

Application No

Application Number

144596
Product/Active constituent Name

Application Product Name

Vismax Specialty

Application details

Product name:

Vismax Specialty

Product number:

95076

Applicant Name:

ELEMENTAL ENZYMES AUSTRALIA PTY LTD

Application purpose and description of use:

Item 2 application for approval of new active constituent Flg22-Bt Peptide and registration of formulated product Vismax Specialty containing not less than 0.065g/L Flg22-Bt Peptide for use on almonds.

Description of data provided:

Data no
274177
Author
Suratwala
Title
EUP Method Validation
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274172
Author
Elemental Enzymes
Title
EUP manufacturing process
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274173
Author
Suratwala
Title
EUP Appearance
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274174
Author
Suratwala
Title
EUP pH
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274175
Author
Suratwala
Title
EUP Viscosity
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274176
Author
Suratwala
Title
EUP SpecificGravity
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274178
Author
APVMA
Title
VISMAX Specialty Crops - Chemistry report product
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274179
Author
APVMA
Title
Specialty Item 25 Cover Letter
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274180
Author
Laura Klasek
Title
Dissociation Constant Waiver
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274170
Author
APVMA
Title
PAA Written Advice
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274171
Author
Various
Title
SDS for non-active ingredients
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
274182
Author
APVMA
Title
APVMA written advice
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274183
Author
Catherine Wo
Title
Persistent Foam
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274185
Author
Laura Klasek
Title
Flg22-Bt0.012%FormulationA_AcceleratedAging
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274184
Author
Patel
Title
Flg22-Bt0.012%FormulationA_Storage Stability
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274181
Author
Rachel Ginther
Title
Flg22-BtPeptideTechnical_Storage Stability
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274246
Author
Abigail Egel
Title
Vismax Efficacy Report_Shothole_Almonds_AGX23144
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274247
Author
Abigail Egel
Title
Vismax Efficacy Report_Shothole_Almonds_AGX22184
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274248
Author
Mark De Lisio
Title
Vismax Efficacy Report_Shothole_Almonds_AGX22182
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274249
Author
Mark De Lisio
Title
Vismax Efficacy Report_Shothole_Almonds_AGX22183
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274250
Author
Mark De Lisio
Title
Vismax Efficacy Report_Shothole_Almonds_AGX22181
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274251
Author
Mark De Lisio
Title
Vismax Efficacy Report_Shothole_Almonds_AGX22180
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274252
Author
Mark De Lisio
Title
Vismax Efficacy Report_Shothole_Almonds_AGX23146
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274253
Author
Mark De Lisio
Title
Vismax Efficacy Report_Shothole_Almonds_AGX23145
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274255
Author
Research 2000
Title
Vismax Efficacy Report_Shothole_Almonds_California_535
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274256
Author
Reserach 2000
Title
Vismax Efficacy Report_Shothole_Almonds_California_536
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274257
Author
Two Brees Ag Research
Title
Vismax Efficacy Report_Shothole_Almonds_California_531
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274258
Author
APVMA
Title
Email from Director Efficacy and Safety
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274245
Author
Dr Sharon Gossage
Title
Part 8 Efficacy
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274254
Author
Elemental Enzymes
Title
COA_G296A-252025_AU
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274224
Author
Anon
Title
Focus Surface Water Modelling
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274225
Author
Anon
Title
Focus Surface Water Modelling - soil application
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274214
Author
Seigneur and Li
Title
Flg22-BtPeptideTechnical_Hydrolysis
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274218
Author
Brougher et al
Title
Flg22-BtPeptideTechnical_RainbowTrout96-hrAcute
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274219
Author
Pawar
Title
Flg22-BtPeptideTechnical_AcuteImmobilizationDaphnia
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274220
Author
Trivedi
Title
Flg22-BtPeptideTechnical_DaphniaMethodValidation
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274228
Author
Griffith et al
Title
Flg22-BtPeptideTechnical_AlgaeToxicity
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
282767
Author
Dr Sharon Gossage
Title
Effects of Flg22-Bt Peptide on Non-target Soil Dwelling Organisms
Study date
2025
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
282768
Author
PRITEE D. SINGH
Title
REPRODUCTION TOXICITY TEST OF FLG22-Bt PEPTIDE TECHNICAL TO EARTHWORM, Eisenia fetida
Study date
Dec 2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
282765
Author
Sebastian H?bner
Title
Flg22-Bt Peptide Technical: Effects on Reproduction of Collembola (Folsomia candida) in Artificial Soil
Study date
October 2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274221
Author
Rana
Title
Flg22-BtPeptideTechnical_AcuteOralToxicityHoneybee
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274222
Author
Rana
Title
Flg22-BtPeptideTechnical_AcuteContactToxicityHoneybee
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
282766
Author
Sebastian H?bner
Title
Flg22-Bt Peptide Technical: Effects on Reproduction of the Predatory Mite Hypoaspis aculeifer in Artificial Soil
Study date
October 2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274233
Author
Abigail Egel
Title
Almond vigour
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274234
Author
Living Farm
Title
Tomato vigour
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274235
Author
Blake Wood
Title
Eggplant vigour
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274236
Author
Jon McCarthy
Title
Turfgrass vigour
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274237
Author
Andrew Ware
Title
Canola vigour
Study date
2021
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274238
Author
Jon Hunt
Title
Potato vigour
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274223
Author
Arnie et al
Title
Flg22-Bt_0.012% FormulationA_SeedlingEmergence
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274212
Author
Dr Sharon Gossage
Title
Part 7 - Environment
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274229
Author
Hostens and Ariyaratne
Title
No direct antimicrobial effect
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274230
Author
Hearn et al
Title
Flg22-BtPeptideTechnical_InVitroDigestion
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274231
Author
Desai
Title
TGAI Water Solubility
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274232
Author
Desai
Title
TGAI Organic Solvent Solubility
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274226
Author
Mark Cafarella
Title
Flg22-Bt Technical_Vegetative Vigor Waiver_
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274239
Author
APVMA
Title
90973-130629 Environmental technical report
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274240
Author
APVMA
Title
90973-130629 Attachment 1 - study summaries - fate
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274241
Author
APVMA
Title
90973-130629 Attachment 2 - study summaries - effects
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274242
Author
APVMA
Title
Specialty Item 25 Cover Letter
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274243
Author
APVMA
Title
PAA written advice_138578
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274244
Author
APVMA
Title
Meeting Minutes_141322
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274227
Author
Klasek et al
Title
Flg22-BtPeptideTechnical_SoilOrganismsWaiver
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274217
Author
Hubbard and Temple
Title
Flg22-BtPeptideTechnical_AvianAcuteOralToxicity
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274259
Author
Dr Sharon Gossage
Title
Executive Summary
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274207
Author
Dr Sharon Gossage
Title
Part 6 OHS - VismaxTM Specialty Crops Item 2
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274208
Author
APVMA
Title
PAA Written Advice
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274209
Author
Haripriya Kalluri and Ajay K. Banga
Title
Transdermal Delivery of Proteins
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
274210
Author
Elemental Enzymes
Title
Vismax Specialty Crops_SDS _AUS_June 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274211
Author
APVMA
Title
Vismax Specialty Crops - HHRA FTR
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274203
Author
Dr Sharon Gossage
Title
Residues Scientific Arugment
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274204
Author
APVMA
Title
PAA Written Advice
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274205
Author
Hearn et al
Title
Flg22-BtPeptideTechnical_InVitroDigestion
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274206
Author
APVMA
Title
Vismax Specialty Crops_130629_Residues
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274194
Author
Chhimwal
Title
Flg22-Bt0.012%FormulationA_AcuteEyeIrritationRabbit
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274202
Author
Durando
Title
Flg22-Bt0.012%FormulationA_AcuteEyeIrritationRabbit
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274193
Author
Verma
Title
Flg22-Bt0.012%FormulationA_AcuteInhalationRat
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274192
Author
Verma
Title
Flg22-Bt0.012%FormulationA_AcuteOralRat
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274201
Author
Durando
Title
Flg22-Bt0.012%FormulationA_AcuteOralRat
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274188
Author
Patel
Title
Flg22-BtPeptideTechnical_BacterialReverseMutation
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274189
Author
Patel
Title
Flg22-BtPeptideTechnical_InVitroMammalianForwardMutation
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274190
Author
Hearne et al
Title
Flg22-BtPeptideTechnical_InVitroDigestion
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274191
Author
Klasek and Leslie
Title
Flg22-BtPeptideTechnical_Allergenicity
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274186
Author
Dr Sharon Gossage
Title
PART 3 ??? TOXICOLOGY
Study date
2024
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274187
Author
APVMA
Title
PAA Written Advice
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274195
Author
Chhimwal
Title
Flg22-Bt0.012%FormulationA_AcuteDermalIrritationRabbit
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274196
Author
Verma
Title
Flg22-Bt0.012%FormulationA_LLNASkinSensitization
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274197
Author
Various
Title
SDS for non-active ingredients
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
274198
Author
APVMA
Title
Vismax Specialty Crops - HHRA FTR
Study date
2022
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274199
Author
APVMA
Title
PAA written advice_138578
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274200
Author
APVMA
Title
Meeting Minutes_141322
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274213
Author
APVMA
Title
PAA Written Advice
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274215
Author
Seigneur and Bianca
Title
Flg22-BtPeptideTechnical_ReadyBiodegradability
Study date
2020
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Data no
274216
Author
Rodriguez
Title
Flg22-BtPeptideTechnical_ReadyBiodegradability
Study date
2023
Authorising party
Applicant
Auth party contact address
6 Palm Street FAIRFIELD Australia
Date

Application Date

Application No

Application Number

144827
Product/Active constituent Name

Application Product Name

Conquest Atomic 200 Selective Herbicide

Application details

Product name:

Conquest Atomic 200 Selective Herbicide

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

To register a 200 g/L formulation of quizalofop-p-ethyl for the control of certain grass weeds in broadleaf crops as per Directions for Use.
Date

Application Date

Application No

Application Number

144474
Product/Active constituent Name

Application Product Name

ADVANTIX FOR DOGS OVER 25KG

Application details

Product name:

ADVANTIX FOR DOGS OVER 25KG

Product number:

58262

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Elanco is submitting this application to request a reduction in the storage conditions for Advantix for Dogs over 25kg (APVMA no. 58262).

Active constituents:

Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN

Description of data provided:

Data no
273293
Author
Elanco Australasia Pty Ltd
Title
Advantix Stability report
Study date
24-03-2020
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

144475
Product/Active constituent Name

Application Product Name

ADVANTIX FOR DOGS 10-25KG

Application details

Product name:

ADVANTIX FOR DOGS 10-25KG

Product number:

58260

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Elanco is submitting this application to request a reduction in the storage conditions for Advantix for Dogs 10-25 kg (APVMA no.58260).

Active constituents:

Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN
Date

Application Date

Application No

Application Number

144476
Product/Active constituent Name

Application Product Name

ADVANTIX FOR DOGS 4-10KG

Application details

Product name:

ADVANTIX FOR DOGS 4-10KG

Product number:

58261

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Elanco is submitting this application to request a reduction in the storage condition for Advantix for Dogs 4-10 kg (APVMA no. 58261).

Active constituents:

Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN
Date

Application Date

Application No

Application Number

144477
Product/Active constituent Name

Application Product Name

ADVANTIX FOR PUPPIES AND SMALL DOGS UP TO 4KG

Application details

Product name:

ADVANTIX FOR PUPPIES AND SMALL DOGS UP TO 4KG

Product number:

58259

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Elanco is submitting this application to request a reduction in the storage conditions for Advantix for Puppies and Small Dogs up to 4 kg (APVMA no. 58259).

Active constituents:

Active constituent name
49016 - IMIDACLOPRID
Active constituent name
54244 - PERMETHRIN
Date

Application Date

Application No

Application Number

144636
Product/Active constituent Name

Application Product Name

PROTEKU SULPHUR DIOXIDE LAMINATED PADS

Application details

Product name:

PROTEKU SULPHUR DIOXIDE LAMINATED PADS

Product number:

64119

Applicant Name:

E.E. MUIR & SONS PTY LIMITED

Application purpose and description of use:

Variation of product registration and label approval to add an additional pack size.

Active constituents:

Active constituent name
60365 - SODIUM METABISULPHITE
Date

Application Date

Application No

Application Number

144887
Product/Active constituent Name

Application Product Name

Azoxystrobin

Application details

Product name:

Azoxystrobin

Active name:

Azoxystrobin

Applicant Name:

SHANGHAI E-TONG CHEMICAL CO LTD

Application purpose and description of use:

Approval of azoxystrobin for use in agricultural chemical products.

Description of data provided:

Data no
275793
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Five Batches Analysis of Azoxystrobin TGAI
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275792
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Description Of Manufacturing Process Of Azoxystrobin And Impurity Information of Azoxystronbin Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275791
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Part 2 Azoxystrobin Chemistry and Manufacturing
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275794
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Azoxystrobin Declaration of Composition (DoC)
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275795
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Azoxystrobin COA, Declaration of Manufacture (DoM) and Letter of Support (LoS)
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275796
Author
Shanghai E-Tong Chemical Co., Ltd
Title
Azoxystrobin MSDS
Study date
2023
Authorising party
Applicant
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
275797
Author
FAO
Title
Azoxystrobin FAO Specification
Study date
2009
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

143997
Product/Active constituent Name

Application Product Name

moxidectin

Application details

Product name:

moxidectin

Product number:

94904

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Registration of a 900 / 657.1 / 228 / 0.9 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.

Description of data provided:

Data no
286171
Author
Elanco
Title
CoA 1 Moxidectin
Study date
June 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286172
Author
Elanco
Title
CoA 2 Moxidectin
Study date
June 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286173
Author
Elanco
Title
CoA 3 Moxidectin
Study date
June 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
274350
Author
Not Identified
Title
API Batch analyses
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
283287
Author
Elanco
Title
3.2.S.4.2 Active constituents CoAs
Study date
2021
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286174
Author
Elanco
Title
11Apr2025 Declaration for moxidectin
Study date
Apr 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286175
Author
Elanco
Title
01APR2025 s159 API Response to Questions AU
Study date
Apr 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

143996
Product/Active constituent Name

Application Product Name

Pyrantel Embonate

Application details

Product name:

Pyrantel Embonate

Product number:

94903

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Registration of a 900 / 657.1 / 228 / 0.9 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.

Description of data provided:

Data no
286167
Author
Elanco
Title
CoA 1 Pyrantel
Study date
July 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286168
Author
Elanco
Title
CoA 2 Pyrantel
Study date
July 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286170
Author
Elanco
Title
CoA 3 Pyrantel
Study date
July 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
286169
Author
Elanco
Title
01APR2025 s159 API Responses to Questions AU
Study date
Apr 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

143999
Product/Active constituent Name

Application Product Name

ADVOCATE ULTRA CHEW for Dogs 5.6 – 11 kg

Application details

Product name:

ADVOCATE ULTRA CHEW for Dogs 5.6 – 11 kg

Product number:

94906

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Registration of a 225 / 164.3 / 57 / 0.225 MG LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.

Reference details:

82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL

Active constituents:

Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Date

Application Date

Application No

Application Number

144000
Product/Active constituent Name

Application Product Name

ADVOCATE ULTRA CHEW for Dogs 11.1 – 22 kg

Application details

Product name:

ADVOCATE ULTRA CHEW for Dogs 11.1 – 22 kg

Product number:

94907

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Registration of a 450 / 328.6 / 114 / 0.45 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.

Reference details:

82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL

Active constituents:

Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner
Date

Application Date

Application No

Application Number

144001
Product/Active constituent Name

Application Product Name

ADVOCATE ULTRA CHEW for Dogs 2.9 – 5.5 kg

Application details

Product name:

ADVOCATE ULTRA CHEW for Dogs 2.9 – 5.5 kg

Product number:

94908

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Registration of a 112.5 / 82.14 / 28.5 / 0.11 LOTILANER/ PYRANTEL PAMOATE / PRAZIQUANTEL / MOXIDECTIN oral chewable tablet (solid oral dose form) for the treatment and control of tick species, treatment and prevention of fleas, prevention of heartworm, treatment and control of intestinal worms.

Reference details:

82857 - CREDELIO 450 mg CHEWABLE TABLETS FOR DOGS
82856 - CREDELIO 225 mg CHEWABLE TABLETS FOR DOGS
82853 - CREDELIO 900 mg CHEWABLE TABLETS FOR DOGS
82855 - CREDELIO 112.5 mg CHEWABLE TABLETS FOR DOGS
82854 - CREDELIO 56.25 mg CHEWABLE TABLETS FOR DOGS
88307 - Lotilaner
89319 - Credelio Plus Chewable Tablets for Very Large Dogs
89318 - Credelio Plus Chewable Tablets for Large Dogs
89317 - Credelio Plus Chewable Tablets for Medium Dogs
89316 - Credelio Plus Chewable Tablets for Small Dogs
89315 - Credelio Plus Chewable Tablets for Very Small Dogs
81958 - PRAZIQUANTEL

Active constituents:

Active constituent name
81958 - PRAZIQUANTEL
Active constituent name
88307 - Lotilaner