Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to register a trade name product under section 9(1) of the Act:

Trade Name: FELIMAZOLE 5MG/ML ORAL SOLUTION

Reference: A012096

Active Ingredients and Concentrations:

Thiamazole (Methimazole) 5mg/mL

Formulation Type: Oral solution

Application method/administration route:

For oral administration only.

Use Claim:

For the stabilisation of feline hyperthyroidism prior to permanent suppression of thyroid hormone (radioactive iodine treatment, surgical thyroidectomy). In the case of radioactive iodine, the veterinarian should consult the radioactive treatment facility for guidance prior to commencing Felimazole treatment, in order to adhere to their pre-treatment protocols.

For the stabilisation of feline hyperthyroidism prior to permanent suppression of thyroid hormone (radioactive iodine treatment, surgical thyroidectomy). In the case of radioactive iodine, the veterinarian should consult the radioactive treatment facility for guidance prior to commencing Felimazole treatment, in order to adhere to their pre-treatment protocols.

For the long-term treatment of feline hyperthyroidism.

A starting regime of 2.5mg (0.5mL) twice a day is recommended for all cats. For cats with significant renal compromise, or other comorbidities for which a sudden drop in glomerular filtration rate would be detrimental, the veterinarian may use their discretion to select a lower starting dose.

For the stabilisation of feline hyperthyroidism prior to permanent suppression of thyroid hormone (radioactive iodine treatment, surgical thyroidectomy): 2.5mg (0.5mL) morning and evening. This should ensure euthyroidism in 3 weeks in most cases.

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 this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.

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 Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submission by email.

The applicant’s address for service is:

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

Dated at Wellington this 12th day of September 2024.

SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).