Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Names:

Vetmedin 1.25mg Capsules for Dogs

Vetmedin 2.5mg Capsules for Dogs

Vetmedin 5mg Capsules for Dogs

References:

A009130-16

A7867-20

A7868-20

Active Ingredients and Concentrations:

Pimobendan 1.25mg per capsule

Pimobendan 2.5mg per capsule

Pimobendan 5mg per capsule

Formulation Type: Capsule

Current Claims:

The treatment of canine congestive heart failure (CHF) originating from dilated cardiomyopathy (DMC) or valvular insufficiency (mitral and/or tricuspid regurgitation).

The treatment of preclinical 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.

Proposed New Claims (changes in bold):

The treatment of canine congestive heart failure (CHF) originating from dilated cardiomyopathy (DMC) or valvular insufficiency (mitral and/or tricuspid regurgitation).

The treatment of preclinical 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 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; 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 notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

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 Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Boehringer Ingelheim (NZ) Limited, Level 1, Unit 9, 42 Ormiston Road, Otara, Auckland 2019.

Dated at Wellington this 9th day of May 2017.

MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).