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: APOQUEL Tablets for Dogs
Reference: A010963
Active Ingredient and Concentration:
Oclacitinib maleate 48.38g/kg
Formulation Type: Tablet
General Use Claims:
For treatment of pruritus associated with allergic dermatitis in dogs.
For the treatment of clinical manifestations of atopic dermatitis 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, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.
The applicant’s address for service is:
Zoetis New Zealand Limited, Level 3, 14 Normandy Road, Mt Eden, Auckland 1024. Postal Address: PO Box 2094, Shortland Street, Auckland 1140.
Dated at Wellington this 20th day of May 2013.
MAREE ZINZLEY, Manager (Approvals Operations), Ministry for Primary Industries (acting under delegated authority).