Maree Zinzley, Manager Approvals, 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 applications have been made to register the following trade name products under section 9(1) of the Act:

Trade Name: Thyforon Thyroxine 200 µg Flavoured Tablets

Reference: A11977-01

Active Ingredient and Concentration:

Levothyroxine Sodium 200μg per tablet

Trade Name: Thyforon Thyroxine 400 µg Flavoured Tablets

Reference: A11978-01

Active Ingredient and Concentration:

Levothyroxine Sodium 400μg per tablet

Formulation Type: Oral Tablet

General Use Claim:

For thyroid replacement therapy in conditions of inadequate production of thyroid hormones in dogs.

Dosage and Administration:

Starting dose: 10µg/kg bodyweight orally every 12 hours. Therapy has to be highly individualised and tailored to the requirements of the individual dog, in accordance with monitoring by the veterinarian.

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, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

The applicant’s address for service is:

Dechra Veterinary Products NZ Limited, 198A Kapiti Road, Paraparaumu 5032, and 2 Cal Close, Somersby, New South Wales 2250, Australia.

Dated at Wellington this 13th day of October 2022.

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