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

151690
Product/Active constituent Name

Application Product Name

Titan Titanium Herbicide

Application details

Product name:

Titan Titanium Herbicide

Product number:

92218

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Variation of label approval to add a new use for the control of a range of weeds with over-the-top application into XtendFlex cotton.

Reference details:

81975 - ROUNDUP READY PL HERBICIDE
81975 - Roundup Ready PL Herbicide With Plantshield Technology

Active constituents:

Active constituent name
62532 - GLYPHOSATE

Description of data provided:

Data no
300695
Author
M. Miller
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
7.1.2026
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300701
Author
E. Ayliffe
Title
Trial ??? Titan Titanium Bioequivalence in XtendFlex Cotton
Study date
April 2024
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300698
Author
C Kelly
Title
Titan Titanium Herbicide Efficacy and Crop Safety Module 8.2
Study date
23.1.2026
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300693
Author
J. Brown
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
16.9.2024
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300699
Author
A. Somervaille
Title
Bioequivalence of Titan Titanium 570 with Roundup Ready PL with Plantshield for Weed Control and Crop Safety in XtendFlex Cotton
Study date
28.9.2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300696
Author
P. Solomon
Title
To Determine the Residues of Glyphosate in XtendFlex Cotton
Study date
3.12.2025
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300702
Author
Titan Ag
Title
Titan Titanium Herbicide draft label
Study date
January 2026
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300697
Author
Titan Ag
Title
Titan Titanium Herbicide draft label
Study date
January 2026
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300694
Author
P. Solomon
Title
To Determine the Residues of Glyphosate in XtendFlex
Study date
13.9.2024
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300692
Author
C Kelly
Title
Titan Titanium Herbicide Residues Module 5.4
Study date
23.1.2026
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
300700
Author
A. Somervaille
Title
Bioequivalence of Titan Titanium 570 with Roundup Ready PL with Plantshield for Crop Safety in XtendFlex Cotton.
Study date
14.10.2024
Authorising party
Applicant
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date

Application Date

Application No

Application Number

151612
Product/Active constituent Name

Application Product Name

DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML SOLUTION FOR INJECTION

Application details

Product name:

DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML SOLUTION FOR INJECTION

Product number:

97038

Applicant Name:

INTAS PHARMACEUTICALS LIMITED

Application purpose and description of use:

Registration of a 0.5 mg/mL dexmedetomidine hydrochloride solution for injection for sedation and analgesia in the restraint of dogs and cats.

Reference details:

64563 - DEXDOMITOR 0.5 MG/ML INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS

Active constituents:

Active constituent name
65797 - FLUROXYPYR-MEPTYL
Active constituent name
97039 - Dexmedetomidine hydrochloride

Description of data provided:

Data no
300137
Author
Anon
Title
GMP Certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
300138
Author
Anon
Title
GMP Certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
300136
Author
Anon
Title
Product specifications
Study date
2026
Authorising party
Applicant
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date

Application Date

Application No

Application Number

151613
Product/Active constituent Name

Application Product Name

Dexmedetomidine hydrochloride

Application details

Product name:

Dexmedetomidine hydrochloride

Active name:

Dexmedetomidine hydrochloride

Applicant Name:

INTAS PHARMACEUTICALS LIMITED

Application purpose and description of use:

New source of pharmacopoeia active constituent

Description of data provided:

Data no
300334
Author
Anon
Title
Certificates of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date

Application Date

Application No

Application Number

151686
Product/Active constituent Name

Application Product Name

PLEVAC PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS

Application details

Product name:

PLEVAC PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS

Product number:

46164

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of the relevant particulars of product registration and label approval to update the instructions of use and align the label with the current Veterinary Labelling Code (VLC); and Variation of the relevant particulars of product registration by updating the formulation details.

Active constituents:

Active constituent name
85954 - Leptospira interrogans serovar pomona
Active constituent name
85955 - Porcine parvovirus

Description of data provided:

Data no
300619
Author
Anon
Title
Cover Letter for application
Study date
January 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306728
Author
Intervet Australia Pty Limited
Title
Response to s159
Study date
12 June 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151737
Product/Active constituent Name

Application Product Name

Alpha-Cypermethrin

Application details

Product name:

Alpha-Cypermethrin

Active name:

Alpha-Cypermethrin

Applicant Name:

DHARMAJ CROP GUARD LIMITED

Application purpose and description of use:

Approval of Alpha-Cypermethrin for use in agricultural chemical products.

Description of data provided:

Data no
301299
Author
Jaman Talavia
Title
Declaration of Batches
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301276
Author
A. Jacob Pinto
Title
Alpha-cypermethrin Technical: Laboratory Study of Flammability & Amendment
Study date
28/09/2024
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301268
Author
Viviane Cangerana Hil??rio Otero
Title
Determination of the Relative Density of Alpha-cypermethrin Technical
Study date
22/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301265
Author
Not Applicable
Title
Summary on physical and chemical properties for Alpha-Cypermethrin
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301285
Author
Not Applicable
Title
MSDS - Active
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301279
Author
K. Ravi Kumar
Title
Alpha-cypermethrin Technical: Laboratory Study of Photodegradation
Study date
03/02/2025
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301302
Author
Not Applicable
Title
Letter on Analytical reference standards
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301262
Author
Not Applicable
Title
Table of contents
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301282
Author
Not Applicable
Title
Summary on Stability data
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301288
Author
Not Applicable
Title
MSDS - Raw material - Sodium Cyanide
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301274
Author
K.Arthi
Title
Alpha-cypermethrin Technical: Laboratory Study of Hydrolysis in Buffer Solutions of pH 4, 7 and 9
Study date
04/01/2025
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301280
Author
S. Jenifer
Title
Alpha-cypermethrin Technical: Laboratory Study of Oxidizing properties & Amendment
Study date
27/09/2024
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301297
Author
Prakash Patel
Title
Declaration of Composition
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301303
Author
Not Applicable
Title
Packaging details of Technical
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301263
Author
Not Applicable
Title
Overall Summary
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301283
Author
Larissa Pasqualini
Title
Accelerated Storage Stability and Corrosion Characteristics of Alphacypermethrin Technical
Study date
23/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301291
Author
Not Applicable
Title
MSDS - Raw material - Soda Ash
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301277
Author
Not Applicable
Title
Justification for Auto-flammability test
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301300
Author
Not Applicable
Title
Analytical methods: Summary Analytical methods
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301271
Author
Larissa Pasqualini
Title
Vapor Pressure of Alphacypermethrin Technical
Study date
10/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301294
Author
Not Applicable
Title
MSDS - Raw material - Triethylamine
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301301
Author
Not Applicable
Title
Validation data: Summary
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301278
Author
A. Jacob Pinto
Title
Alpha-cypermethrin Technical: Determination of Explosive Properties & Amendment
Study date
24/09/2024
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301272
Author
Larissa Pasqualini
Title
Solubility in water and organic solvents (Acetone and n-Hexane) of Alphacypermethrin Technical
Study date
27/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301289
Author
Not Applicable
Title
MSDS - Raw material - Hexane
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301295
Author
Not Applicable
Title
MSDS - Raw material - Sulphuric Acid
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301298
Author
Nat??lia Tagliacozzi Galv??o
Title
Batch analysis data: Qualitative and Quantitative Profile of Alphacypermethrin Technical (Five Batch Analysis)
Study date
27/02/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301275
Author
S. Jenifer
Title
Alpha-cypermethrin Technical: Laboratory Study of Dissociation Constant & Amendment
Study date
23/09/2024
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301269
Author
Not Applicable
Title
Review report for the active substance Alpha-cypermethrin
Study date
2026
Authorising party
Public
Auth party contact address
-
Data no
301266
Author
Viviane Cangerana Hil??rio Otero
Title
Physical State, Appearance, Color, and Odor of Alpha-cypermethrin Technical
Study date
22/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301286
Author
Not Applicable
Title
MSDS - Raw material - MPB
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301292
Author
Not Applicable
Title
MSDS - Raw material -Acetic Acid
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301270
Author
Viviane Cangerana Hil??rio Otero
Title
Determination of the pH value of an aqueous solution of Alphacypermethrin Technical
Study date
22/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301267
Author
Viviane Cangerana Hil??rio Otero
Title
Melting point or range of Alpha-cypermethrin Technical
Study date
22/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301281
Author
Not Applicable
Title
Justification of Auto-ignition temperature test
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301293
Author
Not Applicable
Title
MSDS - Raw material - Sodium Hypochlorite
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301287
Author
Not Applicable
Title
MSDS - Raw material - CMAC
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301273
Author
Larissa Pasqualini
Title
Partition coefficient (N-Octanol/water) of Alphacypermethrin Technical
Study date
23/03/2023
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301264
Author
Not Applicable
Title
Information on identification of the active constituent
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301290
Author
Not Applicable
Title
MSDS - Raw material - TEBA
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301284
Author
Prakash Patel
Title
Documents for Manufacturing Process
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Data no
301296
Author
Prakash Patel
Title
QC Data
Study date
2026
Authorising party
Applicant
Auth party contact address
Kerala GIDC Estate, Off NH-8 At: Kerala Ta: Bavla Ahmedabad India
Date

Application Date

Application No

Application Number

151946
Product/Active constituent Name

Application Product Name

ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS

Application details

Product name:

ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS

Product number:

46409

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of label approval to update the product RLP.

Active constituents:

Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P
Active constituent name
85954 - Leptospira interrogans serovar pomona
Active constituent name
82883 - ERYSIPELOTHRIX RHUSIOPATHIAE SEROTYPE 2 CODE X299 (INACTIVATED)
Active constituent name
82882 - ERYSIPELOTHRIX RHUSIOPATHIAE SEROTYPE 2 CODE 3050 (INACTIVATED)

Description of data provided:

Data no
301362
Author
Not Identified
Title
Cover Letter for application
Study date
February 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306672
Author
Intervet Australia Pty Limited
Title
Response to s159
Study date
12 June 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151947
Product/Active constituent Name

Application Product Name

ECOVAC E COLI VACCINE FOR PIGS

Application details

Product name:

ECOVAC E COLI VACCINE FOR PIGS

Product number:

35779

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of label approval to update the product RLP.

Active constituents:

Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P

Description of data provided:

Data no
301355
Author
Not Identified
Title
Cover Letter for application
Study date
February 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306671
Author
Intervet Australia Pty Limited
Title
Response to s159
Study date
12 June 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151377
Product/Active constituent Name

Application Product Name

SHENZI INSECTICIDE

Application details

Product name:

SHENZI INSECTICIDE

Product number:

92656

Applicant Name:

UPL AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to include the control of Fall armyworm (Spodoptera frugiperda) in Sweetcorn.

Active constituents:

Active constituent name
90705 - chlorantraniliprole

Description of data provided:

Data no
299988
Author
Anon.
Title
Part 8 - Efficacy and crop safety
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
299991
Author
Litzow, D
Title
EVALUATION OF SHENZI INSECTICIDE FOR THE CONTROL OF FALL ARMYWORM IN SWEET CORN
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
299989
Author
Themsen C, Parker D
Title
Investigation of the efficacy and crop safety of UPL CTPR formulations against Fall Armyworm in Sweet Corn
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
299990
Author
Litzow, D
Title
EVALUATION OF SHENZI INSECTICIDE FOR THE CONTROL OF FALL ARMYWORM IN SWEET CORN
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date

Application Date

Application No

Application Number

151723
Product/Active constituent Name

Application Product Name

Supapy-natural Pyrethrin Insecticide

Application details

Product name:

Supapy-natural Pyrethrin Insecticide

Product number:

97084

Applicant Name:

SUPAGAS PTY LIMITED

Application purpose and description of use:

Registration of a 4g/Kg pyrethrin's compressed gas product for control of flying insects and crawling insects.

Reference details:

64288 - SUPAPY INSECTICIDE WITH NATURAL PYRETHRUM

Description of data provided:

Data no
305924
Author
Andrew Dyson
Title
Updated Reference Product Justification and Details for Item 10 Application
Study date
12-May-2026
Authorising party
Applicant
Auth party contact address
5 Benson Rd Ingleburn Australia
Date

Application Date

Application No

Application Number

151392
Product/Active constituent Name

Application Product Name

Permethrin

Application details

Product name:

Permethrin

Active name:

Permethrin

Applicant Name:

Bharat Rasayan Limited

Application purpose and description of use:

Approval of permethrin for use in agricultural and veterinary chemical products.

Description of data provided:

Data no
297847
Author
Anon
Title
DoC
Study date
Dec 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297844
Author
Anon
Title
Caustic Soda
Study date
Dec 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297845
Author
Anon
Title
MPBA SDS
Study date
Dec 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297842
Author
Anon
Title
Permethrin Manufacturing Process
Study date
October 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297843
Author
Anon
Title
Thionyl Chloride SDS
Study date
Dec 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297840
Author
N. Yacoff Sherieff
Title
Chemical Composition of Five Batches of Permethrin Technical Preliminary Analysis and Enforcement Analytical Methods for Permethrin TGAI: fulfilling the Requirements of OPPTS Guideline 830.1700 and 830.1800 and EU Commission Regulation No., 283/2013
Study date
1/12/2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297846
Author
Anon
Title
Permethrin Acid SDS
Study date
Dec 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Data no
297841
Author
Anon
Title
Justification for Permethrin Impurities
Study date
Jan 2025
Authorising party
Applicant
Auth party contact address
1501, Vikram Tower Rajendra Place New Delhi India
Date

Application Date

Application No

Application Number

151688
Product/Active constituent Name

Application Product Name

SPINOMAX PO for Sheep

Application details

Product name:

SPINOMAX PO for Sheep

Product number:

97065

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Registration of a 20g/L spinosad liquid pour-on product for the control of spinosad-susceptible lice (Bovicola ovis), including strains resistant to Synthetic Pyrethroids (SPs), in sheep up to 7 days off-shears and sheep with long wool.

Reference details:

60117 - ELANCO AH0493 EXTINOSAD POUR-ON FOR SHEEP

Active constituents:

Active constituent name
89208 - SPINOSAD

Description of data provided:

Data no
300628
Author
Anon.
Title
Product Specification
Study date
21/04/2022
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
300629
Author
Anon.
Title
Flow diagram
Study date
22/04/2022
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

151766
Product/Active constituent Name

Application Product Name

YATES GRUB KILL & PROTECT FOR LAWNS UP TO 6 MONTHS PROTECTION AGAINST CURL GRUB

Application details

Product name:

YATES GRUB KILL & PROTECT FOR LAWNS UP TO 6 MONTHS PROTECTION AGAINST CURL GRUB

Product number:

88464

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to vary the product name and modify claims

Active constituents:

Active constituent name
61539 - CHLORANTRANILIPROLE

Description of data provided:

Data no
301395
Author
Hall C
Title
Executive Summary - Decision ID DC12-95920840
Study date
30 Jan 2026
Authorising party
Applicant
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

151192
Product/Active constituent Name

Application Product Name

Cattleguard Platinum Dual Active LV Pour-On for Beef and Dairy Cattle

Application details

Product name:

Cattleguard Platinum Dual Active LV Pour-On for Beef and Dairy Cattle

Product number:

96896

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 200 g/L LEVAMISOLE and 10 g/L MOXIDECTIN Pour-On for Beef and Dairy cattle.

Reference details:

88072 - Cydectin Platinum Dual Active LV Pour-On for Beef and Dairy Cattle

Active constituents:

Active constituent name
90215 - LEVAMISOLE HYDROCHLORIDE
Active constituent name
84545 - MOXIDECTIN

Description of data provided:

Data no
296224
Author
Zoetis Australia Pty Ltd
Title
Product Specification
Study date
November 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

151344
Product/Active constituent Name

Application Product Name

[Wagg & Purr] Milbemycin and Praziquantel Tablets for Dogs

Application details

Product name:

[Wagg & Purr] Milbemycin and Praziquantel Tablets for Dogs

Product number:

96962

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of 125 mg praziquantel and 12.5 mg milbemycin oxime tablets for the treatment and control of roundworm, whipworm, hookworm and tapeworm, and the prevention of heartworm in dogs.

Reference details:

59225 - MILBEMAX TABLETS FOR SMALL DOGS AND PUPPIES
54266 - MILBEMAX TABLETS FOR DOGS
54265 - MILBEMAX TABLETS FOR CATS
54264 - MILBEMAX TABLETS FOR SMALL CATS
94540 - [Wagg & Purr] Milbemycin and Praziquantel Tablets for Cats
94549 - [Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Cats
54263 - MILBEMAX TABLETS FOR SMALL DOGS

Active constituents:

Active constituent name
94564 - Milbemycin oxime
Active constituent name
94565 - Praziquantel

Description of data provided:

Data no
297146
Author
Anon
Title
Milbemycin oxime certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297169
Author
Anon
Title
EU 4b p1
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297177
Author
Anon
Title
Safety report 1
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297183
Author
Anon
Title
Excipient 2 information
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297186
Author
EMA
Title
Guideline on the conduct of bioequivalence studies for veterinary medicinal products
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
297163
Author
Anon
Title
EU 2e4 p2
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297143
Author
Anon
Title
Part 2 Chemistry and Manufacture
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297157
Author
Anon
Title
EU 2c3
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297149
Author
Anon
Title
Excipient 1
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297180
Author
Shesky PJ et al
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
297140
Author
Anon
Title
Certificate
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
297166
Author
Anon
Title
EU 1c3 p1
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297160
Author
Anon
Title
EU 2e2 p1
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297152
Author
Anon
Title
Milbemycin oxime information
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297175
Author
Anon
Title
EU 4a p3
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297181
Author
Anon
Title
Excipient 1 information
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297161
Author
Anon
Title
EU 2e4 p1
Study date
2019
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297141
Author
Anon
Title
Certificate
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
297155
Author
Anon
Title
Excipient 4
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297172
Author
Anon
Title
EU 4b p4
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297178
Author
Anon
Title
Safety report 2
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297184
Author
Anon
Title
Excipient 3 information
Study date
2023
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297164
Author
Anon
Title
EU 2f2
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297144
Author
Anon
Title
EU 2a4
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297158
Author
Anon
Title
EU 2e1 p1
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297173
Author
Anon
Title
EU 4a p1
Study date
2014
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297150
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
297179
Author
European Agency for the Evaluation of Medicinal Products
Title
Praziquantel summary report
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
297139
Author
Anon
Title
Certificate
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
297167
Author
Anon
Title
EU 1c3 p2
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
297153
Author
Anon
Title
Milbemycin oxime information
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297159
Author
Anon
Title
EU 2e1 p1
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297176
Author
Anon
Title
EU 4a p4
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297147
Author
Anon
Title
Praziquantel certificates of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297170
Author
Anon
Title
EU 4b p2
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297187
Author
Anon
Title
EU 2a4
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
301080
Author
Anon
Title
Application
Study date
2026
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297156
Author
Anon
Title
EU 2b
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297148
Author
Anon
Title
Excipients certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297171
Author
Anon
Title
EU 4b p3
Study date
2019
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297165
Author
Anon
Title
Part 8 Efficacy and Safety
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297145
Author
Anon
Title
EU 1c1
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297151
Author
Anon
Title
Milbemycin oxime information
Study date
2021
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297174
Author
Anon
Title
EU 4a p2
Study date
2013
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297182
Author
Anon
Title
Excipient 1 paper
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297185
Author
Anon
Title
Excipient 3 certificate
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297162
Author
Anon
Title
EU 2e2 p2
Study date
2020
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297142
Author
Anon
Title
Report
Study date
2025
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297168
Author
Anon
Title
EU 1c2
Study date
2022
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Data no
297154
Author
Anon
Title
Excipient 3
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

151346
Product/Active constituent Name

Application Product Name

[Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Dogs and Puppies

Application details

Product name:

[Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Dogs and Puppies

Product number:

96964

Applicant Name:

AVET HEALTH LIMITED

Application purpose and description of use:

Registration of 25 mg praziquantel and 2.5 mg milbemycin oxime tablets for the treatment and control of roundworm, whipworm, hookworm and tapeworm, and the prevention of heartworm in dogs.

Reference details:

59225 - MILBEMAX TABLETS FOR SMALL DOGS AND PUPPIES
54266 - MILBEMAX TABLETS FOR DOGS
54265 - MILBEMAX TABLETS FOR CATS
54264 - MILBEMAX TABLETS FOR SMALL CATS
94540 - [Wagg & Purr] Milbemycin and Praziquantel Tablets for Cats
94549 - [Wagg & Purr] Milbemycin and Praziquantel Tablets for Small Cats
54263 - MILBEMAX TABLETS FOR SMALL DOGS

Active constituents:

Active constituent name
94564 - Milbemycin oxime
Active constituent name
94565 - Praziquantel

Description of data provided:

Data no
297124
Author
Anon
Title
2e1 p1
Study date
2024
Authorising party
Applicant
Auth party contact address
Rialto, L2 Podium East 525 Collins Street MELBOURNE Australia
Date

Application Date

Application No

Application Number

151735
Product/Active constituent Name

Application Product Name

Picaridin

Application details

Product name:

Picaridin

Active name:

Picaridin

Applicant Name:

THEYES MANAGEMENT PTY LTD

Application purpose and description of use:

Approval of Picaridin for use in agricultural chemical products.

Description of data provided:

Data no
301342
Author
Anon
Title
CERTIFICATE OF ANALYSIS
Study date
01/12/2024
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301331
Author
J. Shan
Title
Validation of Analytical Methodology for the Assay of Active Ingredient and Impurities and Subsequent five batches Qualitative and Quantitative Analysis of Icaridin TC
Study date
13/10/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301339
Author
B. Praveen
Title
DETERMINATION OF PARTITION COEFFICIENT OF ICARIDIN TC
Study date
08/10/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301334
Author
B. Praveen
Title
DETERMINATION OF BOILING POINT OF ICARIDIN TC
Study date
11/08/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301340
Author
Anon
Title
Declaration of composition
Study date
12/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301337
Author
B. Praveen
Title
DETERMINATION OF SOLUBILITY OF ICARIDIN TC IN ORGANIC SOLVENTS
Study date
27/07/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301332
Author
Anon
Title
Production chemistry of Icaridin technical
Study date
02/2025
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301338
Author
B. Praveen
Title
DETERMINATION OF WATER SOLUBILITY OF ICARIDIN TC
Study date
05/09/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301341
Author
Anon
Title
MSDS
Study date
11/03/2024
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301335
Author
B. Praveen
Title
DETERMINATION OF pH OF ICARIDIN TC
Study date
31/10/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301336
Author
B. Praveen
Title
DETERMINATION OF DENSITY OF ICARIDIN TC
Study date
18/07/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Data no
301333
Author
B. Praveen
Title
DETERMINATION OF PHYSICAL STATE, COLOR AND ODOR OF ICARIDIN TC
Study date
31/10/2022
Authorising party
Applicant
Auth party contact address
11 Condor Street Hawthorn East Australia
Date

Application Date

Application No

Application Number

151738
Product/Active constituent Name

Application Product Name

Azoxystrobin

Application details

Product name:

Azoxystrobin

Active name:

Azoxystrobin

Applicant Name:

AGOCEANIA PTY LTD

Application purpose and description of use:

Approval of Azoxystrobin for use in agricultural chemical products.

Description of data provided:

Data no
301345
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Manufacture Process of Azoxystrobin Technical
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301348
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
The statement of batch size of Azoxystrobin technical in 5-batch report
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301346
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
The Justification of Impurities of Azoxystrobin Technical
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301343
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Five Batches Analysis of Azoxystrobin TC
Study date
January 11, 2016
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301349
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Physical and chemical properties of Azoxystrobin
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301347
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
DoC of Azoxystrobin TC
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301344
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Test QC results of Azoxystrobin in the random samples produced in January 2022 to May 2023
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
301350
Author
Jiangsu Frey Agrochemicals Co., Ltd.
Title
Registration Data of Azoxystrobin
Study date
July 5, 2023
Authorising party
Applicant
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Date

Application Date

Application No

Application Number

151347
Product/Active constituent Name

Application Product Name

PROTECH C4 + 2I

Application details

Product name:

PROTECH C4 + 2I

Product number:

51489

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of product registration to remove non-standard conditions applied to the registration.

Active constituents:

Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
83719 - CANINE PARAINFLUENZA VIRUS
Active constituent name
83799 - LEPTOSPIRA INTERROGANS SEROVAR COPENHAGENI (INACTIVATED)
Active constituent name
83720 - CANINE CORONAVIRUS INACTIVATED
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
83719 - CANINE PARAINFLUENZA VIRUS
Active constituent name
83720 - CANINE CORONAVIRUS INACTIVATED

Description of data provided:

Data no
299902
Author
Boehringer Ingelheim
Title
Batch 5257038A
Study date
27/01/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299905
Author
Boehringer Ingelheim
Title
Stability report - Protech C4
Study date
28/02/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299917
Author
Boehringer Ingelheim
Title
CCV3198THV Inactivation kinetics QC results
Study date
27/01/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299911
Author
Boehringer Ingelheim
Title
3291021 - batch report
Study date
20/05/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299914
Author
APVMA
Title
PAA 139907 - written advice
Study date
13/07/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299908
Author
Boehringer Ingelheim
Title
CPV3184THV 001
Study date
28/11/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299900
Author
Boehringer Ingelheim
Title
Batch 5257037B
Study date
28/10/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299909
Author
Boehringer Ingelheim
Title
CAV3203THV 002
Study date
07/03/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299903
Author
Boehringer Ingelheim
Title
Batch 5257038B
Study date
27/01/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299920
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics QC test results
Study date
02/09/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299906
Author
Boehringer Ingelheim
Title
CAV3203THV 012 batch report
Study date
12/08/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299912
Author
Boehringer Ingelheim
Title
3291022 - batch report
Study date
09/07/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299904
Author
Boehringer Ingelheim
Title
Batch 5257039
Study date
21/05/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299921
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics report
Study date
10/08/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299915
Author
Boehringer Ingelheim
Title
Stability report - Protech C2i
Study date
30/10/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299901
Author
Boehringer Ingelheim
Title
Batch 5257037
Study date
28/10/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299918
Author
Boehringer Ingelheim
Title
CCV3198THV Inactivation kinetics report
Study date
11/03/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299913
Author
Boehringer Ingelheim
Title
antigen stability
Study date
01/06/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299907
Author
Boehringer Ingelheim
Title
CDV3166TC 001
Study date
22/01/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299919
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics protocol
Study date
30/03/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299899
Author
Boehringer Ingelheim
Title
Batch 5257037A-part 1
Study date
28/10/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299922
Author
Boehringer Ingelheim
Title
Executive summary Protech C4 + 2i
Study date
08/12/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299916
Author
Boehringer Ingelheim
Title
CCV3198THV Inactivation kinetics protocol
Study date
14/12/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299910
Author
Boehringer Ingelheim
Title
3291019 - batch report
Study date
07/12/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

151348
Product/Active constituent Name

Application Product Name

PROTECH C3 + 2I

Application details

Product name:

PROTECH C3 + 2I

Product number:

51490

Applicant Name:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

Application purpose and description of use:

Variation of product registration to remove non-standard conditions applied to the registration.

Active constituents:

Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
83799 - LEPTOSPIRA INTERROGANS SEROVAR COPENHAGENI (INACTIVATED)
Active constituent name
83720 - CANINE CORONAVIRUS INACTIVATED
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
83799 - LEPTOSPIRA INTERROGANS SEROVAR COPENHAGENI (INACTIVATED)
Active constituent name
83720 - CANINE CORONAVIRUS INACTIVATED

Description of data provided:

Data no
299925
Author
Boehringer Ingelheim
Title
4964019 - batch records
Study date
29/05/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299931
Author
Boehringer Ingelheim
Title
3201019 batch report
Study date
07/12/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299928
Author
Boehringer Ingelheim
Title
CDV3166TC 001
Study date
22/01/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299934
Author
Boehringer Ingelheim
Title
Antigen stability
Study date
01/06/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299937
Author
Boehringer Ingelheim
Title
CCV3198THV inactivation kinetics protocol
Study date
14/12/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299923
Author
Boehringer Ingelheim
Title
4964015 - batch records
Study date
01/08/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299929
Author
Boehringer Ingelheim
Title
CPV3184THV 001
Study date
28/11/2017
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299940
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics protocol
Study date
30/03/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299926
Author
Boehringer Ingelheim
Title
Stability report - Protech C4
Study date
28/02/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299943
Author
Boehringer Ingelheim
Title
Executive summary - Protech C3 + 2i
Study date
10/12/2025
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299932
Author
Boehringer Ingelheim
Title
3201021 batch report
Study date
20/05/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299927
Author
Boehringer Ingelheim
Title
CAV3203THV 012
Study date
12/08/2022
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299935
Author
APVMA
Title
PAA 139907 written advice
Study date
04/07/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299938
Author
Boehringer Ingelheim
Title
CCV3198THV inactivation kinetics QC results
Study date
29/01/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299924
Author
Boehringer Ingelheim
Title
4964016A - batch records
Study date
10/10/2023
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299941
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics QC test results
Study date
02/09/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299942
Author
Boehringer Ingelheim
Title
LI3210TC inactivation kinetics report
Study date
10/08/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299933
Author
Boehringer Ingelheim
Title
3201022 batch report
Study date
09/07/2024
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299930
Author
Boehringer Ingelheim
Title
CAV3203THV 002
Study date
07/03/2018
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299936
Author
Boehringer Ingelheim
Title
Stability report - Protech C2i
Study date
30/10/2020
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
299939
Author
Boehringer Ingelheim
Title
CCV3198THV inactivation kinetics report
Study date
11/03/2021
Authorising party
Applicant
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date

Application Date

Application No

Application Number

151440
Product/Active constituent Name

Application Product Name

MORANTEL CITRATE

Application details

Product name:

MORANTEL CITRATE

Active name:

MORANTEL CITRATE

Applicant Name:

PHIBRO ANIMAL HEALTH PTY LIMITED

Application purpose and description of use:

Approval of morantel citrate for use in veterinary chemical products.

Description of data provided:

Data no
298729
Author
APVMA
Title
APVMA email
Study date
23/2/2016
Authorising party
Applicant
Auth party contact address
Unit 3, 10 Gladstone Road Castle Hill Australia
Data no
298728
Author
Anon
Title
Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 3, 10 Gladstone Road Castle Hill Australia