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: Vetmedin 1.5mg/mL Oral Solution for Dogs

Reference: A012206

Active Ingredients and Concentrations:

pimobendan 1.5mg/mL

Formulation Type: Aqueous solution

Application method/administration route:

Vetmedin 1.5mg/mL Oral Solution for Dogs should be administered orally at a dose range of 0.1–0.3mg pimobendan/kg bodyweight twice daily. The ideal dose is 0.25mg pimobendan/kg bodyweight (equivalent to 0.17mL/kg) twice daily administered 12 hours apart.

Use Claim:

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy (DCM) or valvular insufficiency (mitral and/or tricuspid valve regurgitation). The treatment of pre-clinical DCM in large breed dogs. When used in cases of preclinical DCM in large breed dogs, pimobendan significantly prolonged the time to the onset of CHF or sudden death, and also resulted in prolongation of the time to death due to all causes. Doberman Pinscher dogs with preclinical DCM treated with pimobendan also demonstrated a significant reduction in Left Ventricular Internal Diameter in both systole and diastole (LVIDs/d) in response to therapy.

For the treatment of dogs with evidence of increased heart size secondary to asymptomatic (preclinical) myxomatous mitral valve disease to delay the onset of clinical symptoms of heart failure, to reduce heart size and to increase survival time.

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:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 2, 3 Te Kehu Way, Mount Wellington, Auckland. Postal Address: PO Box 76211, Manukau, Auckland 2241.

Dated at Wellington this 3rd day of July 2025.

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