Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to register a trade name product under section 9(1) of the Act:

Trade Name: Duotic Ear Gel for Dogs

Reference: A012138

Active Ingredients and Concentrations:

10mg terbinafine 1mg betamethasone acetate per 1.2g (1 Dose)

Formulation Type: Gel

Application method/administration route:

Administer one tube per infected ear. Repeat the administration after seven days to complete the course of treatment. Each infected ear should receive a total of two tubes, seven days apart.

Use Claim:

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis).

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission; and
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.

The following address is:

1. where submissions on this application are to be sent; and
2. where requests for copies of the public information relating to the application can be sent; and
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submission by email.

The applicant’s address for service is:

Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032. Postal Address: PO Box 1604, Paraparaumu.

Dated at Wellington this 28th day of August 2024.

SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).