Maree Zinzley, Manager Approvals Operations, 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 (“the Act”), that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Names:

Fortekor Plus 5mg pimobendan/10mg Benazepril HCl Tablets for Dogs
Fortekor Plus 1.25mg pimobendan/2.5mg benazepril HCl Tablets for Dogs

References: A11170, A11169

Active Ingredients and Concentrations:

Fortekor Plus 5mg pimobendan/10mg Benazepril HCl Tablets for Dogs
Fortekor Plus 1.25mg pimobendan/2.5mg benazepril HCl Tablets for Dogs

Formulation Type: Tablet

General Use Claim:

For treatment of congestive heart failure in dogs.

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:

Craig Cunningham, Novartis New Zealand Limited, 109 Carlton Gore Road, Newmarket, Auckland 1023.

Dated at Wellington this 29th day of September 2015.

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