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 variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: Folltropin-V

Reference: A005535

Active Ingredients and Concentrations:

Follicle Stimulating Hormone (equivalent to 20mg*/mL when reconstituted according to directions) 400mg

*Each vial contains the equivalent of 400mg National Institutes of health (U.A.A.) reference standard NIH-FSH-P1

Formulation Type: Powder for reconstitution

Current Claim:

As a supplemental source of follicle stimulating hormone (FSH). To induce superovulation in specialised breeding programs. Use in cattle, horses, goats, sheep and dogs

Current Administration pattern:

Administration:

For superovulation in heifers and cows – intramuscular injection

Used twice daily for four consecutive days at the rate of 4–20mL for cattle

To induce superovulation:

Administer by deep intramuscular injection. Start injection animals on day 8–10 after observed heat. Regimen: As per individual clinical experience, twice daily for four days.

Administer prostaglandin F2α or a prostaglandin F2α analogue in order to induce heat for breeding.

Proposed New Claim: (changes in bold):

For use in breeding-age heifers or cows to induce superovulation.

Proposed Administration Pattern: Intramuscular injection

For cattle: used twice daily for four consecutive days at the rate of 2.5mL (50mg*)

To induce superovulation:

Administer by deep intramuscular injection. Start injection of animals on day 8–10 after observed or induced heat.

Regimen: As per individual clinical experience, 2.5mL (50mg*) twice daily for four days. In conjunction with the sixth dose of the product, administer prostaglandin F2α or prostaglandin F2α analogue, at the manufacturer’s recommended dose, to cause luteolysis.

Inseminate animals at 12–24 hours after the onset of oestrus or 60 and 72 hours after prostaglandin treatment. Additional inseminations may be conducted at 12-hour intervals if indicated.

Collection of embryos is normally started on day seven following insemination.

The claim for use in horses, goats, sheep and dogs has been withdrawn.

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:

Vetoquinol New Zealand Limited, Level 5, 60 Parnell Road, Parnell, Auckland 1052. Postal Address: PO Box 112, Pinkenba, Queensland 4008, Australia.

Dated at Wellington this 17th day of February 2022.

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