Notice Type
Departmental
Notice Title

Notice of Application to Register a Trade Name Product (Notice No. MPI 749)

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 application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Cardalis Tablets for Dogs

Reference: A011439-01

Active Ingredients and Concentrations:

Cardalis® Tablets for Small Dogs
Spironolactone 20mg and Benazepril hydrochloride 0.25mg per tablet
Cardalis® Tablets for Medium Dogs
Spironolactone 40mg and Benazepril hydrochloride 5mg per tablet
Cardalis® Tablets for Large Dogs
Spironolactone 80mg and Benazepril hydrochloride 10mg per tablet

Formulation Type: Tablet

General Use Claim:

Cardalis® is indicated for the treatment of heart failure and reduction in mortality caused by chronic degenerative valvular disease 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;
  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;
  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 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:

Ceva Animal Health (NZ) Limited, 74 Westney Road, Mangere, Auckland 2150.

Dated at Wellington this 1st day of May 2017.

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