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: Zenalpha Injection for Dogs

Reference: A012035

Active Ingredients and Concentrations:

10mg/mL Vatinoxan hydrochloride (equivalent to 9.2mg/mL Vatinoxan) and 0.5mg/mL medetomidine hydrochloride (equivalent to 0.425mg/mL medetomidine)

Formulation Type: Aqueous solution

Application method/administration route:

Intramuscular injection at 1mg of medetomidine hydrochloride and 20mg of vatinoxan hydrochloride (equivalent to 2mL of solution) per square meter of body surface area.

Use Claim:

A sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, and minor surgical procedures

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;
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;
2. where requests for copies of the public information relating to the application can be sent;
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: 2 Cal Close, Somersby, New South Wales 2250, Australia.

Dated at Wellington this 13th day of November 2024.

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