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 Name: Metacam 0.5mg/mL Oral Suspension for Cats
Reference: A009832-14
Active Ingredient and Concentration:
Meloxicam 0.5mg/mL
Formulation Type: Aqueous suspension
Current Claim:
Alleviation of inflammation and pain in acute and chronic musculo-skeletal disorders such as disco-spondylosis, arthopathy and soft tissue injuries in cats.
Proposed New Claims (changes in bold):
Alleviation of inflammation and pain in acute and chronic musculo-skeletal disorders such as disco-spondylosis, arthopathy and soft tissue injuries in cats. For the relief of post-operative pain associated with soft tissue surgery, such as castration, in guinea pigs.
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:
- must state in full the reasons for making the submission;
- may state any decision sought on that application; and
- 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:
- where submissions on this application are to be sent;
- where requests for copies of the public information relating to the application can be sent;
- where public information relating to the application can be viewed; and
- 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) Ltd, Level 3, 3 Osterley Way, Manukau, Auckland 2104. Postal Address: PO Box 76211, Manukau City, Auckland 2241.
Dated at Wellington this 16th day of October 2018.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).