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

149525
Product/Active constituent Name

Application Product Name

SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS

Application details

Product name:

SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS

Product number:

96490

Applicant Name:

S.C. JOHNSON & SON PTY LTD

Application purpose and description of use:

Registration of a 9.6 g/kg indoxacarb bait (equivalent to 5 g/kg of the active S-isomer) for the control of cockroaches in household situations.

Reference details:

61513 - RAID MAX COCKROACH BAITS

Active constituents:

Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE

Description of data provided:

Data no
291308
Author
Anon
Title
Example Batch Analysis for active constituent
Study date
2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291309
Author
Anon
Title
APVMA Public Release Summary on Evaluation of the new active Indoxacarb (S-Isomer) in the product DUPONT STEWARD EC INSECTICIDE
Study date
February 2007
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291314
Author
Ania Yarnton
Title
Method Validation for the determination of indoxacarb in SC Johnson A Family Company Raid Max Cockroach Baits (Validation Report No. ACS-VR-165-11)
Study date
11 July 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291311
Author
Nguyen Hong An
Title
Manufacturing Process
Study date
2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291312
Author
Anon
Title
Certificate of Analysis of SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Study date
2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291310
Author
Anon
Title
MSDSs and specifications for constituents
Study date
2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291315
Author
Anon
Title
Safety Data Sheet - SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Study date
2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291316
Author
Australian Government - Department of Agriculture, Fisheries and Forestry (DAFF)
Title
Biosecurity Import Conditions (BICON) Permit
Study date
2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291321
Author
J. Walsh
Title
Summary Part 2 Chemistry and Manufacture
Study date
August 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291313
Author
Philip Pentland
Title
Stability Testing of SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS (EUR14-44-1)
Study date
February 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291317
Author
Dr Peter F. Miller
Title
Laboratory Study to Determine the Secondary Kill of SC Johnson A Family Company Raid Cockroach Baits and Mortein Kill and Protect Cockroach Baits Against the German and American Cockroach (PRC Ref. No. R24-2228)
Study date
11 July 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291318
Author
Dr Peter F. Miller
Title
Laboratory Study to Determine the Time Taken by SC Johnson A Family Company Raid Max Cockroach Baits and Raid Max Cockroach Baits to Kill American and German Cockroaches (PRC Ref. No. R24-2229)
Study date
11 July 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291319
Author
Dr Peter F. Miller
Title
Arena Study to Determine the Efficacy of SC Johnson A Family Company Raid Max Cockroach Baits Against the German and American Cockroach- Six Month Study (PRC Ref. No. R24-2227 p)
Study date
11 July 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291320
Author
Dr Peter F. Miller
Title
Laboratory Study to Determine the Secondary Kill of SC Johnson A Family Company Raid Cockroach Baits and Mortein Kill and Protect Cockroach Baits Against the German and American Cockroach (PRC Ref. No. R25-2244)
Study date
11 July 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291322
Author
J. Walsh
Title
Summary Part 8 Efficacy and Safety
Study date
August 2025
Authorising party
S.C. JOHNSON & SON PTY LTD
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Date

Application Date

Application No

Application Number

149658
Product/Active constituent Name

Application Product Name

ASHOXY OXYTETRACYCLINE 300 MG/ML LA INJECTION

Application details

Product name:

ASHOXY OXYTETRACYCLINE 300 MG/ML LA INJECTION

Product number:

96530

Applicant Name:

ASHISH LIFE SCIENCE PVT. LTD.

Application purpose and description of use:

Registration of a 300 mg/mL oxytetracycline (as dihydrate) injectable product for broad spectrum antibiotic treatment in cattle, sheep and pigs.

Reference details:

53087 - ALAMYCIN LA 300 OXYTETRACYCLINE INJECTABLE SOLUTION

Active constituents:

Active constituent name
93420 - Oxytetracycline dihydrate

Description of data provided:

Data no
290712
Author
Anon
Title
Product specifications
Study date
2025
Authorising party
Applicant
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
294722
Author
Anon
Title
Declaration
Study date
2025
Authorising party
Applicant
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
290713
Author
Anon
Title
Certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date

Application Date

Application No

Application Number

149551
Product/Active constituent Name

Application Product Name

TapOut Surfactant

Application details

Product name:

TapOut Surfactant

Product number:

96500

Applicant Name:

CROP CULTURE PTY LTD

Application purpose and description of use:

Registration of TapOut Surfactant (904 g/L DI-1-P-MENTHENE), non-aqueous concentrate formulation, a sticking-spreader agent designed to control the life of pesticides.

Reference details:

52216 - MILLER NU-FILM-P NON-IONIC STICKER-SPREADER
61397 - MILLER NU-FILM-17 NON IONIC EXTENDER-STICKER-SPREADER
66601 - CAMPBELL FILMSTAR-21 NON-IONIC EXTENDER, STICKER AND SPREADER
83108 - Brandt Tarp Extender Sticker Spreader
88028 - Pro-Film 904 Non-Ionic Extender-Sticker-Spreader
Date

Application Date

Application No

Application Number

149653
Product/Active constituent Name

Application Product Name

deltamethrin

Application details

Product name:

deltamethrin

Active name:

deltamethrin

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Approval of deltamethrin for use in veterinary chemical products.

Description of data provided:

Data no
290692
Author
Anon
Title
COA x 3
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
290693
Author
British Pharmacopoeia
Title
Deltamethrin BP Vet monograph
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

149500
Product/Active constituent Name

Application Product Name

Titan Cazone Herbicide

Application details

Product name:

Titan Cazone Herbicide

Product number:

96478

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Registration of a 400 g/L carfentrazone-ethyl EC product for the desiccation of potato crops prior to harvest.

Reference details:

88110 - TITAN CARFENTRAZONE 400EC HERBICIDE
61716 - SPOTLIGHT PLUS HERBICIDE

Active constituents:

Active constituent name
68094 - CARFENTRAZONE-ETHYL

Description of data provided:

Data no
291259
Author
Kohler, D; Cross, S & Johnson, S.
Title
Evaluation of Titan Carfentrazone 400 EC and Titan Diquat 200 for preharvest desiccation in potatoes cv. Nicola
Study date
18 June 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291260
Author
Kohler, D; Cross, S & Johnson, S.
Title
Evaluation of Titan Carfentrazone 400 EC and Titan Diquat 200 for preharvest desiccation in potatoes cv. Russet Burbank
Study date
18 June 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291261
Author
Bushell, B.
Title
Potato Desiccation Bioequivalence
Study date
17 June 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291262
Author
Bushell, B.
Title
Potato Desiccation Bioequivalence
Study date
17 June 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291263
Author
Ramsdale, T.
Title
Potato Des ??? Carfentrazone ??? Bioequivalence to Spotlight Plus Single Application
Study date
8 July 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291264
Author
Ramsdale, T.
Title
Potato Des ??? Carfentrazone ??? Bioequivalence to Spotlight Plus Split Application
Study date
8 July 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291266
Author
Kelly, C.
Title
Titan Cazone Efficacy and Safety Module 8.2
Study date
7 August 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291265
Author
Titan Ag Pty ltd
Title
Titan Cazone Herbicide draft label
Study date
7 August 2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date

Application Date

Application No

Application Number

149649
Product/Active constituent Name

Application Product Name

NO Pantry Moths Pheromone Traps Citrus

Application details

Product name:

NO Pantry Moths Pheromone Traps Citrus

Product number:

96525

Applicant Name:

AMALGAMATED HARDWARE MERCHANTS (AUSTRALIA) PTY LIMITED

Application purpose and description of use:

Registration of a 4.9 g/kg (Z,E)-9,12-TETRADECADIEN-1-YL ACETATE ready to use bait formulation to attract and trap pantry moths.

Reference details:

95054 - NO Pantry Moths Pheromone Traps

Description of data provided:

Data no
291257
Author
AMALGAMATED HARDWARE MERCHANTS (AUSTRALIA) PTY LIMITED
Title
Manufacturer's Declaration
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 1, 169 Given Terrace Paddington Australia
Data no
291258
Author
AMALGAMATED HARDWARE MERCHANTS (AUSTRALIA) PTY LIMITED
Title
Executive Summary
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 1, 169 Given Terrace Paddington Australia
Date

Application Date

Application No

Application Number

149449
Product/Active constituent Name

Application Product Name

KUNKOP INSECTICIDE

Application details

Product name:

KUNKOP INSECTICIDE

Product number:

96475

Applicant Name:

UPL AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 240 g/L Spinosad, aqueous suspension concentrates for use in fruit, herbs, ornamentals, vegetables and forestry (Eucalyptus spp. and Tea Tree) for the control of certain insect pests as specified in the Directions for Use.

Reference details:

88118 - Entrust Organic Qalcova Active Insecticide

Active constituents:

Active constituent name
94741 - SPINOSAD

Description of data provided:

Data no
291154
Author
Patel, D
Title
Validation of Analytical method for determination of active ingredient content of Spinosad 240 g/L SC
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291151
Author
Patil, M
Title
Chemical composition, Product Specification and Manufacturing process
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291149
Author
Nguyen, T
Title
SPINO200_Part 2 Chemistry & Manufacturing
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291150
Author
Anon
Title
Document J
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291155
Author
Mukhekar, SR
Title
Persistent foaming of Spinosad 240 g/L SC
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291156
Author
Anon
Title
Spinosad technical COA
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291152
Author
Patel, D
Title
Accelerated storage stability and corrosion characteristics of Spinosad 240 g/L SC
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291153
Author
Mukhekar, SR
Title
Stability of Spinosad 240 g/L SC at low temperature
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291168
Author
Innes, L
Title
To test the efficacy of UPL Spinosad formulations against Entrust 240 against Cherry slug in Stone Fruit Echunga, South Australia, 2022
Study date
2022
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291169
Author
Ryan,C
Title
To test the efficacy of UPL formulations for bioequivalence to Entrust 240,Toolamba, Victoria, 2023
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291170
Author
Bougoure, D
Title
Evaluation of the bioequivalence of UPL Spinosad 240 with Entrust for the control of citrus leaf miner in lime
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291157
Author
Nguyen, T
Title
Part 8 240 Spinosad_KUNKOP INSECTICIDE
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291158
Author
Themsen, C and Parker, D
Title
To evaluate the efficacy and crop safety of UPL Spinosad 240 for bioequivalence to Entrust Organic
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291159
Author
Litzow, D
Title
Evaluation of the bioequivalence of UPL Spinosad with Entrust for the control Lepidoptera pests in broccoli, Clifton Queensland 2003
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291160
Author
Johns, S
Title
To test the efficacy of UPL formulations for the bioequivalence to Entrust 240, Mount Barker, Sout Australia, Australia
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291161
Author
Nguyen, T
Title
Efficacy of UPL Spinosad formulations for control of diamondback moth (Plutella xylostella) in brussels sprouts cv. Trimstar
Study date
2022
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291162
Author
Hutcheon, E
Title
Comparison of UPL Spinosad 240 SC and 480 SC with Entrust 240 SC and Success Neo 120 SC for the control of diamondback moth (Plutella xylostella) in Chinese cabbage (Brassica rapa pekinensis) cv. Matilda. Wanneroo, Western Australia, 2022
Study date
2022
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291163
Author
Nguyen, T
Title
Efficacy of UPL Spinosad formulations for control of western flower thrips (Frankliniella occidentalis) in capsicum cv. Remy, Angle Vale, South Australia, 2022/23
Study date
2022
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291165
Author
Litzow, D
Title
Evaluation of the bioequivalence of UPL Spinosad formulations with Entrust for the control of Lepidopteran pests in sweet corn
Study date
2022
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291166
Author
Anfuso, A
Title
To test the efficacy of UPL Spinosad for bioequivalence to Entrust 240 aversham, Western Australia, 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291167
Author
Andrews, O
Title
To test the efficacy of UPL formulations for bioequivalence to Entrust 240, Nashdale, New South Wales, 2023
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291164
Author
Litzow, D
Title
Evaluation of bioequivalence of UPL Spinosad formulations and Entrust 240 for the control of Heliothis in lettuce Clifton Queensland Australia 2023/2024
Study date
2023
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291171
Author
Anon
Title
KUNKOP INSECTICIDE label
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date

Application Date

Application No

Application Number

149549
Product/Active constituent Name

Application Product Name

Tribeca Fungicide

Application details

Product name:

Tribeca Fungicide

Product number:

89902

Applicant Name:

TURF CULTURE PTY LTD

Application purpose and description of use:

To update and add additional descriptive text to label.

Active constituents:

Active constituent name
88784 - Fludioxonil
Active constituent name
69141 - TRITICONAZOLE
Date

Application Date

Application No

Application Number

149527
Product/Active constituent Name

Application Product Name

XtendiMax 2 Herbicide with VapourGrip Technology

Application details

Product name:

XtendiMax 2 Herbicide with VapourGrip Technology

Product number:

88630

Applicant Name:

MONSANTO AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of label approval to add a tank mix

Reference details:

93058 - VapourGrip Xtra Agent
94751 - Roundup UltraMax Herbicide with Plantshield

Active constituents:

Active constituent name
52040 - DICAMBA
Active constituent name
85321 - Dicamba
Active constituent name
44512 - DICAMBA

Description of data provided:

Data no
291327
Author
Frein J and Kalubowilage M
Title
Bridging Statement. M-882595-01-1
Study date
2025-07-22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291328
Author
Fitzgerald M
Title
Efficacy and safety module. M-883389-01-1
Study date
2025-08-11
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291326
Author
McCormick, N.
Title
Letter of consent to access protected data and information
Study date
2025-08-04
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Date

Application Date

Application No

Application Number

149552
Product/Active constituent Name

Application Product Name

Clevor 30 mg/mL Eye Drops Solution

Application details

Product name:

Clevor 30 mg/mL Eye Drops Solution

Product number:

94343

Applicant Name:

MAVLAB ANIMAL HEALTH PTY LTD

Application purpose and description of use:

Variation of product registration to vary relevant particulars.

Active constituents:

Active constituent name
94342 - Ropinirole hydrochloride

Description of data provided:

Data no
290431
Author
Anon
Title
Certificate 2
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
290429
Author
Anon
Title
Certificate 1
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
290430
Author
Anon
Title
Letter
Study date
2025
Authorising party
Applicant
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Date

Application Date

Application No

Application Number

149529
Product/Active constituent Name

Application Product Name

Metham-sodium

Application details

Product name:

Metham-sodium

Active name:

Metham-sodium

Applicant Name:

Zhejiang Dapeng Pharmaceutical Co.,Ltd.

Application purpose and description of use:

Approval of metham-sodium manufacturing concentrate for use in agricultural chemical products.

Description of data provided:

Data no
291331
Author
Zhejiang Dapeng Pharmaceutical Co., Ltd.
Title
Qualitative and Quantitative Profile of the test substance Metham-sodium (Five Batch Analysis)
Study date
2025
Authorising party
Applicant
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291330
Author
Zhejiang Dapeng Pharmaceutical Co., Ltd.
Title
Synthesis and Impurities of Metham-sodium Technical
Study date
2025
Authorising party
Applicant
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291329
Author
Zhejiang Dapeng Pharmaceutical Co., Ltd.
Title
Chemistry and Manufacture
Study date
2025
Authorising party
Applicant
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291332
Author
Zhejiang Dapeng Pharmaceutical Co., Ltd.
Title
Declaration of Composition (DoC) of Metham-sodium
Study date
2025
Authorising party
Applicant
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291333
Author
Zhejiang Dapeng Pharmaceutical Co., Ltd.
Title
Certificate of Analysis (COA) and Statement of Batch Size of Metham-sodium
Study date
2025
Authorising party
Applicant
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291334
Author
Zhejiang Dapeng Pharmaceutical Co., Ltd.
Title
Metham-sodium SAFETY DATA SHEET
Study date
2025
Authorising party
Applicant
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Date

Application Date

Application No

Application Number

149526
Product/Active constituent Name

Application Product Name

VapourGrip Xtra Agent

Application details

Product name:

VapourGrip Xtra Agent

Product number:

93058

Applicant Name:

MONSANTO AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of label approval to add a tank mix

Reference details:

94751 - Roundup UltraMax Herbicide with Plantshield

Active constituents:

Active constituent name
60575 - ACETIC ACID
Active constituent name
59979 - POTASSIUM HYDROXIDE

Description of data provided:

Data no
291325
Author
Fitzgerald, M.
Title
Efficacy and safety module. M-883389-01-1
Study date
2025-08-11
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291324
Author
Frein J and Kalubowilage M
Title
Bridging Statement. M-882595-01-1
Study date
2025-07-22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291323
Author
McCormick, N.
Title
Letter of consent to access protected data and information
Study date
2025-08-04
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Date

Application Date

Application No

Application Number

149524
Product/Active constituent Name

Application Product Name

Solectus 60 mg/mL Injection for Cattle

Application details

Product name:

Solectus 60 mg/mL Injection for Cattle

Product number:

96489

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Registration of an injectable solution containing 60 mg/mL umifoxolaner for use as an ectoparasiticide in cattle, in conjunction with approval of umifoxolaner.

Description of data provided:

Data no
290015
Author
Boehringer Ingelheim
Title
Analytical Procedures for the Drug Product
Study date
16 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290016
Author
Boehringer Ingelheim
Title
Validation of Analytical Procedures for the Drug Product
Study date
16 Oct 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290104
Author
Boehringer Ingelheim
Title
Reference Standards for Drug Product
Study date
04 Mar 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290008
Author
Boehringer Ingelheim
Title
Batch Analyses for the Drug Product
Study date
23 Aug 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290009
Author
Boehringer Ingelheim
Title
Certifcate of Analysis for the Drug Product
Study date
07 May 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290017
Author
Boehringer Ingelheim
Title
Specifications for the Container Closure Components
Study date
13 Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290018
Author
Boehringer Ingelheim
Title
Certificates of Analysis for the Container Closure Components
Study date
13 May 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289999
Author
EUDRA
Title
Certificate of GMP Compliance of a Manufacturer
Study date
15/06/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290000
Author
Boehringer Ingelheim
Title
Batch Formula -Umifoxolaner 60 mg/mL Solution for Injection for Cattle
Study date
17 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290001
Author
Boehringer Ingelheim
Title
Certificates of Analysis for Excipients
Study date
16 Dec 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290002
Author
Unknown
Title
Specifications for Excipients
Study date
01/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290003
Author
Boehringer Ingelheim
Title
Excipients of Human or Animal Origin
Study date
21 Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290004
Author
Boehringer Ingelheim
Title
Description of the Manufacturing Process and Process Controls - Umifoxolaner 60 mg/mL Solution
Study date
17 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290005
Author
Boehringer Ingelheim
Title
Justification of Controls at Critical Steps
Study date
25 Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290006
Author
Boehringer Ingelheim
Title
Specifications for the Drug Product
Study date
17 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290007
Author
Boehringer Ingelheim
Title
Justification of the Specifications for the Drug Product
Study date
18 Apr 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290103
Author
Boehringer Ingelheim
Title
Packaging Procedure - Umifoxolaner 60 mg/mL Solution for Injection for Cattle
Study date
25 Mar 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290102
Author
Boehringer Ingelheim
Title
Pharmaceutical Development - Umifoxolaner 60 mg/mL Solution for Injection for Cattle
Study date
15 Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289998
Author
Boehringer Ingelheim
Title
Solectus 60 mg/mL Injection for Cattle Part 2 Chemistry and Manufacture Summary
Study date
8 August 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290052
Author
Boehringer Ingelheim
Title
Safety data sheets
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290010
Author
Boehringer Ingelheim
Title
Stability Summary and Conclusions
Study date
19 May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290011
Author
Boehringer Ingelheim
Title
Stability Data - Accelerated and Long-Term Stability Studies for the Drug Product
Study date
19 May 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290012
Author
Boehringer Ingelheim
Title
Stability Data - Stress Stability Studies for the Drug Product - Photostability
Study date
17 Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290013
Author
Boehringer Ingelheim
Title
Stability Studies - Stress Stability Studies for the Drug Product - Temperature Cycling
Study date
17 Jul 2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290014
Author
Boehringer Ingelheim
Title
Stability Data - In-Use Stability Studies for the Drug Product
Study date
07 Mar 2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290093
Author
Boehringer Ingelheim
Title
ML-3,032,878: AN AQUEOUS EXPOSURE BIOACCUMULATION TEST WITH THE BLUEGILL
Study date
01/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290094
Author
Boehringer Ingelheim
Title
ML-3,032,878: AN AQUEOUS EXPOSURE BIOACCUMULATION TEST WITH THE BLUEGILL - raw data files
Study date
01/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290095
Author
Boehringer Ingelheim
Title
A NON-GLP PILOT AQUEOUS EXPOSURE BIOACCUMULATION TEST WITH THE BLUEGILL
Study date
16/06/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290073
Author
Boehringer Ingelheim
Title
ML-3,032,878: Aerobic Transformation in Soils
Study date
06/07/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290063
Author
Boehringer Ingelheim
Title
ML-3,032,878: ANAEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS
Study date
24/08/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290064
Author
Boehringer Ingelheim
Title
ML-3,032,878: ANAEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS - raw data files
Study date
24/08/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290065
Author
Boehringer Ingelheim
Title
ML-3,032,878: PILOT ANAEROBIC TRANSFORMATION STUDY IN AQUATIC SEDIMENT SYSTEMS
Study date
24/08/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290060
Author
Boehringer Ingelheim
Title
ML-3,032,878: AEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS
Study date
19/07/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290061
Author
Boehringer Ingelheim
Title
ML-3,032,878: AEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS - raw data files
Study date
19/07/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290083
Author
Boehringer Ingelheim
Title
ML-3,032,878: ADSORPTION/DESORPTION CHARACTERISTICS IN REPRESENTATIVE SOILS AND ACTIVATED SLUDGE SOLIDS
Study date
24/02/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290084
Author
Boehringer Ingelheim
Title
ML-3,032,878: ADSORPTION/DESORPTION CHARACTERISTICS IN REPRESENTATIVE SOILS AND ACTIVATED SLUDGE SOLIDS- raw data
Study date
24/02/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290057
Author
Boehringer Ingelheim
Title
ML-3,032,878 - determining the partitioning coefficient
Study date
02/02/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290071
Author
Boehringer Ingelheim
Title
ML-3,032,878 Determination of the Abiotic Degradation by Hydrolysis
Study date
13/07/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290087
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Acute Toxicity Test with Bluegill Sunfish,
Study date
11/06/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290088
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Acute Toxicity Test with Bluegill Sunfish -raw data files
Study date
11/06/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290089
Author
Boehringer Ingelheim
Title
ML-3,032,878 Acute Toxicity to Water Fleas
Study date
20/12/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290090
Author
Boehringer Ingelheim
Title
ML-3,032,878 Acute Toxicity to Water Fleas - raw data files
Study date
20/12/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290091
Author
Boehringer Ingelheim
Title
ML-3,032,878 Full Life-Cycle Toxicity Test with Water Fleas
Study date
09/01/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290092
Author
Boehringer Ingelheim
Title
ML-3,032,878 Full Life-Cycle Toxicity Test with Water Fleas - raw data files
Study date
09/01/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290096
Author
Boehringer Ingelheim
Title
ML-3,032,878 - 72-Hour Toxicity Test with the Freshwater Green Alga
Study date
05/10/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290097
Author
Boehringer Ingelheim
Title
ML-3,032,878 - 72-Hour Toxicity Test with the Freshwater Green Alga - raw data files
Study date
05/10/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290068
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Toxicity Test with Sediment-Dwelling Midges
Study date
03/03/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290069
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Toxicity Test with Sediment-Dwelling Midges - raw data files
Study date
23/08/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290070
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Toxicity Test with Sediment-Dwelling Midges - pilot
Study date
28/09/2016
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290074
Author
Boehringer Ingelheim
Title
ML-3,032,878: Chronic Toxicity and Reproduction Test Exposing the Earthworm,
Study date
24/01/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290075
Author
Boehringer Ingelheim
Title
ML-3,032,878: Chronic Toxicity and Reproduction Test Exposing the Earthworm, - raw data files
Study date
24/01/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290076
Author
Boehringer Ingelheim
Title
ML-3,032,878: Acute Toxicity to Earthworms
Study date
27/01/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290098
Author
Boehringer Ingelheim
Title
ML-3,032,878: Determination of the Reproduction Toxicity to the Dung Beetle
Study date
26/06/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290099
Author
Boehringer Ingelheim
Title
ML-3,032,878: Determination of the Reproduction Toxicity to the Dung Beetle - raw data files
Study date
26/06/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290100
Author
Boehringer Ingelheim
Title
Determination of Developmental Toxicity to the Dipteran Dung Fly
Study date
27/06/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290101
Author
Boehringer Ingelheim
Title
Determination of Developmental Toxicity to the Dipteran Dung Fly - raw data files
Study date
27/06/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290085
Author
Boehringer Ingelheim
Title
ML-3,032,878: developmental toxicity to the dipteran dung fly
Study date
03/11/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290086
Author
Boehringer Ingelheim
Title
ML-3,032,878: developmental toxicity to the dipteran dung fly - raw data files
Study date
03/11/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290077
Author
Boehringer Ingelheim
Title
ML-3,032,878: Chronic Toxicity to Collembola
Study date
11/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290078
Author
Boehringer Ingelheim
Title
ML-3,032,878: Chronic Toxicity to Collembola - raw data files
Study date
11/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290079
Author
Boehringer Ingelheim
Title
ML-3,032,878: Chronic Toxicity to Collembola - pilot
Study date
02/11/2016
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290053
Author
Boehringer Ingelheim
Title
Executive summary - Environment
Study date
29/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290055
Author
Boehringer Ingelheim
Title
Environment risk assessment
Study date
16/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290056
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Purity Determination
Study date
07/11/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289997
Author
Boehringer Ingelheim
Title
Overall executive summary - Solectus
Study date
29/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290054
Author
APVMA
Title
PAA advice 144405
Study date
24/07/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290039
Author
APVMA
Title
PAA 117847
Study date
12/04/2019
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290020
Author
Boehringer Ingelheim
Title
PR&D 04026 A comparative metabolism study following repeated oral (gavage) administration to rats
Study date
01/12/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290021
Author
Boehringer Ingelheim
Title
PR&D 04027 A comparative metabolism study following repeated oral (gavage) administration to Beagle dogs
Study date
12/11/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290023
Author
Boehringer Ingelheim
Title
2021-1122 ML-3,032,878: A 28 day pharmacokinetic study of ML-3,032,878 by intravenous injection and oral gavage in Sprague Dawley Rats
Study date
05/11/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290024
Author
Boehringer Ingelheim
Title
2019247 A comparative study of [14C]- ML-3,032,878 following repeated oral (gavage) administration to rats
Study date
07/05/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290025
Author
Boehringer Ingelheim
Title
PR&D 0390901 Plasma protein binding of ML-3,032,878 in cattle, sheep, dog, rat and mouse plasma
Study date
02/03/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290022
Author
Boehringer Ingelheim
Title
PR&D 0390801 Metabolite profiling of ML-3,032,878 in H REL Rat, Mouse, Dog, Cattle and Sheep Hepatocytes Co-cultures
Study date
27/02/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290026
Author
Boehringer Ingelheim
Title
2022-2004 A Study to Determine the Pharmacokinetic Profile of ML-3,032,878 in Plasma of Cattle When Administered Once as a Single Intravenous dose (0.6 mg/kg body weight) or a Single Subcutaneous Dose
Study date
17/06/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290105
Author
Boehringer Ingelheim
Title
User Risk Assessment
Study date
8/08/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290058
Author
Boehringer Ingelheim
Title
Pivotal Radio-Residue Metabolism Study
Study date
10/01/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290028
Author
Boehringer Ingelheim
Title
2023-2790 Eye irritation test and BCOP final formulation
Study date
07/09/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290029
Author
Boehringer Ingelheim
Title
2023-2791 Epiderm skin irritation test final formulation
Study date
11/09/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290030
Author
Boehringer Ingelheim
Title
2023-2878 Local lymph node assay in mice final formulation
Study date
01/11/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290038
Author
Boehringer Ingelheim
Title
ML-3,032,878: A 52-week oral dietary toxicity study in Sprague Dawley Rats
Study date
21/09/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290027
Author
Boehringer Ingelheim
Title
PR&D 03698 ML-3,032,878: EXPLORATORY IN VITRO STUDY TO ASSESS TERATOGENIC POTENTIAL IN ZEBRAFISH EMBRYO CULTURE
Study date
24/08/2016
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290040
Author
Boehringer Ingelheim
Title
PR&D 0392501 ML-3,032,878: An oral (gavage) range-finding reproductive toxicity study in Sprague Dawley Rats
Study date
19/12/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290041
Author
Boehringer Ingelheim
Title
PR&D 04286 ML-3,032,878: An oral (gavage) two-generation reproductive toxicity study in Sprague Dawley Rats
Study date
11/10/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290042
Author
Boehringer Ingelheim
Title
PR&D 0383501 ML-3,032,878: An oral (gavage) dose range finding study on embryo/fetal development in Sprague Dawley rats
Study date
18/03/2019
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290043
Author
Boehringer Ingelheim
Title
PR&D 03836 ML-3,032,878: An oral (gavage) tolerability and range-finding study on Embryo/fetal development in rabbits
Study date
18/03/2019
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290044
Author
Boehringer Ingelheim
Title
PR&D 04284 ML-3,032,878: An oral (gavage) prenatal developmental toxicity study in Sprague Dawley rats
Study date
01/1/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290045
Author
Boehringer Ingelheim
Title
PR&D 04285 ML-3,032,878: An oral (gavage) prenatal developmental toxicity study in New Zealand white rabbits
Study date
19/10/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290046
Author
Boehringer Ingelheim
Title
PR&D 03747 ML-3,032,878 bacterial reverse mutation assay
Study date
03/01/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290047
Author
Boehringer Ingelheim
Title
PR&D 03677 ML-3,032,878 In vitro mammalian cell micronucleus assay in TK6 cells
Study date
31/1/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290048
Author
Boehringer Ingelheim
Title
PR&D 03748 ML-3,032,878: In vivo mammalian erythrocyte micronucleus assay in mice
Study date
14/02/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290049
Author
Boehringer Ingelheim
Title
Proposal of Acceptable Daily Intake
Study date
31/10/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290050
Author
Boehringer Ingelheim
Title
2024-3935 Determination of Minimal Inhibitory Concentrations (MICs) for Umifoxolaner and open chain metabolite of Umifoxolaner
Study date
23/12/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290051
Author
Boehringer Ingelheim
Title
Establishment of acute reference dose
Study date
19/03/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290019
Author
Boehringer Ingelheim
Title
Executive summary - health
Study date
29/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290031
Author
Boehringer Ingelheim
Title
PR&D 03603 ML-3,032,878: a 7-day oral gavage toxicity study in Sprague Dawley Rats
Study date
18/07/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290032
Author
Boehringer Ingelheim
Title
PR&D 03708 ML-3,032,878: A 7-day oral (dietary) palatability study in Sprague Dawley Rats
Study date
04/08/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290033
Author
Boehringer Ingelheim
Title
PR&D 03604 ML-3,032,878: 28-day oral (dietary) toxicity study in Sprague Dawley Rats
Study date
25/04/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290034
Author
Boehringer Ingelheim
Title
PR&D 03713 ML-3,032,878: An escalating-dose phase and 7-day repeated-dose phase study by oral capsule in Beagle dogs
Study date
13/10/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290035
Author
Boehringer Ingelheim
Title
PR&D 03714 ML-3,032,878: a 28 day repeated-dose study by oral capsule in Beagle dogs
Study date
19/12/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290036
Author
Boehringer Ingelheim
Title
PR&D 0371201 ML-3,032,878: a 90 day oral toxicity study in Sprague Dawley Rats
Study date
20/06/2019
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290037
Author
Boehringer Ingelheim
Title
PR&D 0378601 ML-3,032,878: a 90 day oral (capsule) toxicity study in Beagle dogs
Study date
29/01/2019
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290059
Author
Boehringer Ingelheim
Title
Determination of the concent of active ingredient
Study date
29/04/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290062
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Validation of the Analytical Method for the Determination of a Test Article in Sediment
Study date
12/02/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290080
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Determining the Water Solubility
Study date
23/04/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290081
Author
Boehringer Ingelheim
Title
ML-3,032,878 - Determining the Water Solubility - raw data files
Study date
23/04/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290082
Author
Boehringer Ingelheim
Title
ML-3,032,878 - valiation of the analytical method for the degtermination of a test article in aqueous solutions
Study date
17/02/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290072
Author
Boehringer Ingelheim
Title
ML-3,032,878 determination of melting point
Study date
28/11/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290066
Author
Boehringer Ingelheim
Title
ML-3,032,878: TRANSFORMATION IN CATTLE MANURE PILOT STUDY
Study date
02/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290067
Author
Boehringer Ingelheim
Title
ML-3,032,878: TRANSFORMATION IN CATTLE MANURE PILOT STUDY - raw data files
Study date
02/07/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

149528
Product/Active constituent Name

Application Product Name

Swan Imidacloprid 600 FS Insecticide

Application details

Product name:

Swan Imidacloprid 600 FS Insecticide

Applicant Name:

SWAN CHEMICAL HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 600 g/L Imidacloprid flowable seed treatment (FS) product for the Control of Various Insect Pests in a Range of Crops and the Protection of Spread of Barley Yellow Dwarf Virus in Cereal Crops
Date

Application Date

Application No

Application Number

149530
Product/Active constituent Name

Application Product Name

F.S.A. Pinoxaden 100 EC Herbicide

Application details

Product name:

F.S.A. Pinoxaden 100 EC Herbicide

Applicant Name:

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use:

Registration of a 100 g/L emulsifiable concentrate formulation of pinoxaden and 25 g/L cloquintocet-mexyl for control of key grass weeds and selective spray topping of wild oats in Barley and Wheat
Date

Application Date

Application No

Application Number

149493
Product/Active constituent Name

Application Product Name

Quali-Pro Nutmeg Herbicide

Application details

Product name:

Quali-Pro Nutmeg Herbicide

Product number:

90028

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of product label to provide more clarity on approved uses.

Active constituents:

Active constituent name
63533 - BENTAZONE
Date

Application Date

Application No

Application Number

149860
Product/Active constituent Name

Application Product Name

One Dose Australlia Liquid Chlorine

Application details

Product name:

One Dose Australlia Liquid Chlorine

Applicant Name:

ONE DOSE AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 125 g/L Sodium Hypochlorite, aqueous solution for the control of algae & bacteria in swimming pools.
Date

Application Date

Application No

Application Number

149510
Product/Active constituent Name

Application Product Name

Cyantraniliprole

Application details

Product name:

Cyantraniliprole

Active name:

Cyantraniliprole

Applicant Name:

AGROBEATS TECH CO. LTD.

Application purpose and description of use:

Approval of Cyantraniliprole for use in agricultural chemical products.

Description of data provided:

Data no
291277
Author
Stephen Chen
Title
Five Batch Analysis of Cyantraniliprole Technical
Study date
October 2024
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291275
Author
Anon
Title
Manufacturing Process and Impurity Information of Cyantraniliprole Technical
Study date
August 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291276
Author
Jerry Lee
Title
Declaration of Composition
Study date
April 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291278
Author
Anon
Title
Cyantraniliprole - Part 2-Chemistry 0825
Study date
August 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291274
Author
Anon
Title
Cyantraniliprole Executive Summary August 2025
Study date
August 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Date

Application Date

Application No

Application Number

149511
Product/Active constituent Name

Application Product Name

Mandipropamid

Application details

Product name:

Mandipropamid

Active name:

Mandipropamid

Applicant Name:

AGROBEATS TECH CO. LTD.

Application purpose and description of use:

Approval of Mandipropamid for use in agricultural chemical products.

Description of data provided:

Data no
291284
Author
Stephen Chen
Title
Five Batch Analysis of Mandipropamid Technical
Study date
November 2024
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291282
Author
Anon
Title
Manufacturing Process of Mandipropamid TC and Impurities Justification
Study date
September 2024
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291283
Author
Li Yun
Title
Declaration of Composition
Study date
July 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291285
Author
Anon
Title
Mandipropamid - Part 2-Chemistry 0825
Study date
August 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Data no
291281
Author
Anon
Title
Mandipropamid Executive Summary August 2025
Study date
August 2025
Authorising party
Applicant
Auth party contact address
C-47, No.69, Shuangfeng Road Pukou Economic Development Zone PUKOU DISTRICT China
Date

Application Date

Application No

Application Number

149517
Product/Active constituent Name

Application Product Name

Cry51Aa2

Application details

Product name:

Cry51Aa2

Product number:

96485

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Registration of a biological agricultural product Bollgard 3 ThryvOn cotton for the suppression of various Thrips spp., in conjunction with approval of a new active constituent Cry51Aa2. Approval of Bacillus thuringiensis toxin Cry51Aa2 and its controlling sequences for use in biological agricultural products in conjunction with the registration of Bollgard 3 ThryvOn cotton.

Description of data provided:

Data no
290606
Author
Garnaat, C.; Duong, C.; Kessenich, C.; Silvanovich, A.; Urquhart, W.
Title
Amended report for MSL0028391: Molecular Characterization of Insect Protected Cotton MON 88702
Study date
24/05/2018
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
290608
Author
Hall, R.
Title
Letter of authorisation for APVMA to reference Syngenta data for Bayer MON 88702 x MON 15985 x COT102 x MON 88701 x MON 88913 application.
Study date
31/07/2025
Authorising party
Syngenta Australia Pty Ltd
Auth party contact address
Licensor
Data no
290607
Author
Robinson, K.A.; Malven, M.
Title
Amended Report for MSL0026822: Segregation Analysis of the T-DNA Insert in Insect-protected Cotton MON 88702 Across Three Generations
Study date
01/03/2016
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
290610
Author
Nina McCormick
Title
Part 2 - Chemistry, manufacture and biological properties for: Bollgard 3 ThryvOn cotton containing new active constituent Cry51Aa2 (Module 2.2)
Study date
22/07/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
290611
Author
Nina McCormick
Title
Part 3 - Toxicology data: Bollgard 3 ThryvOn cotton containing new active constituent Cry51Aa2 (Module 3.4)
Study date
22/07/2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
290609
Author
Landin, K.L.
Title
Amended from MSL0027647: An Acute Oral Gavage Toxicity Study of Cry51Aa2.834_16 Protein in CD-1 Mice
Study date
10/01/2017
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia