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: Tildren 500mg lyophilisate for solution for infusion

Reference: A11167

Active Ingredient and Concentration:

Tiludronic acid (as disodium tiludronate) 500mg/vial

Formulation Type: Freeze-dried powder for reconstitution with an isotonic solution

General Use Claim:

For the treatment for lameness associated with bone and cartilage changes in horses.

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:

Lee Metcalf, c/o Bell Gully, Level 22, Vero Centre, 48 Shortland Street, Auckland 1010. Postal Address: Lee Metcalf, CEVA Animal Health (NZ) Limited, 11 Moores Road, Glenorie, New South Wales 2157, Australia.

Dated at Wellington this 3rd day of February 2015.

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