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 ("the Act"), that the following application has been made to register a trade name product under section 9(1) of the Act:
Trade Name: Vetmedin 0.75mg/mL injectable solution for dogs
Reference: A10757
Active Ingredient and Concentration
Pimobendan 0.75mg/ml
Formulation Type: Aqueous liquid
General Use Claim: To initiate treatment of congestive heart failure origination from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation) 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:
(a) must state in full the reasons for making the submission; and
(b) may state any decision sought on that application; and
(c) 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:
(a) where submissions on this application are to be sent; and
(b) where requests for copies of the public information relating to the application can be sent; and
(c) where public information relating to the application can be viewed; and
(d) the director-general’s address for service:
ACVM Group, Ministry for Primary Industries, Level 11, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Boeringer Ingelheim (NZ) Limited, Level 1, Unit 9,
42 Ormiston Road, East Tamaki, Auckland. Postal Address: Animal Health Division, 78 Waterloo Road, North Ryde, New South Wales 2113, Australia.
Dated at Wellington this 2nd day of July 2012.
MAREE ZINZLEY, Manager (Approvals Operations), Ministry for Primary Industries (acting under delegated authority).