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 No
151265
 Product/Active constituent Name
Izenivetmab

Application details

Product name:

Izenivetmab

Product number:

96924

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application No
151266
 Product/Active constituent Name
Izenivetmab

Application details

Product name:

Izenivetmab

Product number:

96925

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application No
151267
 Product/Active constituent Name
Lenivia 0.5 mg Solution for Injection for Dogs

Application details

Product name:

Lenivia 0.5 mg Solution for Injection for Dogs

Product number:

96926

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 0.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.

Description of data provided:

Data no
304889
Author
EMA
Title
Interpretation of the Union format for GMP certificate
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
304890
Author
Zoetis
Title
Zoetis 8AHAA Notice Response
Study date
Apr 2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
304888
Author
Eudra GMP
Title
GMP Certificate Site B
Study date
2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application No
151268
 Product/Active constituent Name
Lenivia 1 mg Solution for Injection for Dogs

Application details

Product name:

Lenivia 1 mg Solution for Injection for Dogs

Product number:

96927

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 1 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application No
151269
 Product/Active constituent Name
Lenivia 1.5 mg Solution for Injection for Dogs

Application details

Product name:

Lenivia 1.5 mg Solution for Injection for Dogs

Product number:

96928

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 1.5 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application No
151270
 Product/Active constituent Name
Lenivia 2 mg Solution for Injection for Dogs

Application details

Product name:

Lenivia 2 mg Solution for Injection for Dogs

Product number:

96929

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 2 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application No
151271
 Product/Active constituent Name
Lenivia 3 mg Solution for Injection for Dogs

Application details

Product name:

Lenivia 3 mg Solution for Injection for Dogs

Product number:

96930

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 3 mg/mL izenivetmab solution for injection intended for the alleviation of pain associated with osteoarthritis in dogs in conjunction with the approval of the active ingredient izenivetmab.
Date
Application No
151406
 Product/Active constituent Name
Ant & Roach Dusting Powder

Application details

Product name:

Ant & Roach Dusting Powder

Product number:

96980

Applicant Name:

Lifeguard Sciences (Pty) Ltd

Application purpose and description of use:

The following data summary has been compiled in support of the application for the registration of Ant & Roach Dusting Powder, a formulated insecticidal product containing Permethrin (5 g/kg) and Piperonyl Butoxide (40 g/kg) as active constituents. This product is intended for the control of fleas, cockroaches, and ants and is designed for application in agricultural, industrial, commercial, and residential settings.

Reference details:

66574 - BIN BUDDY BERRY INSECTICIDE
Date
Application No
151413
 Product/Active constituent Name
APPEAR II Turf Fungicide

Application details

Product name:

APPEAR II Turf Fungicide

Product number:

96981

Applicant Name:

SYNGENTA AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 335 g/L phosphorous acid present as the mono-di-potassium phosphite in a soluble liquid formulation product for the prevention and control of diseases caused by Pythium spp. in turf.

Reference details:

87962 - Kenso Agcare Ken-Fos 600 Systemic Fungicide
48147 - M-DKP FOLI-R-FOS 400 FUNGICIDE
54430 - AGRI-FOS 600 SYSTEMIC FUNGICIDE
Date
Application No
151690
 Product/Active constituent 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
Date
Application No
151963
 Product/Active constituent Name
Headway Amoxiclav 500 mg Tablets

Application details

Product name:

Headway Amoxiclav 500 mg Tablets

Applicant Name:

HEADWAY INVESTMENTS PTY LTD

Application purpose and description of use:

Registration of a Amoxiclav 500 mg Tablet product for use in Calves and dogs for bacterial infections.
Date
Application No
150306
 Product/Active constituent Name
Sedator Injection

Application details

Product name:

Sedator Injection

Product number:

82623

Applicant Name:

RANDLAB AUSTRALIA PTY LTD

Application purpose and description of use:

Item 12 Appplication for the inclusion of overseas manufacturer in addition to the currently approved manufacturers in Australia.
Date
Application No
151612
 Product/Active constituent 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
Date
Application No
151613
 Product/Active constituent 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
Date
Application No
151686
 Product/Active constituent 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 label approval to update the product RLP.
Date
Application No
151737
 Product/Active constituent 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.
Date
Application No
151946
 Product/Active constituent 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.
Date
Application No
151947
 Product/Active constituent 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.
Date
Application No
151377
 Product/Active constituent 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.
Date
Application No
151688
 Product/Active constituent 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