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: Leptoshield Pacifica

Registration No.: A011888

Active Ingredients and Concentrations:

Leptospira borgpetersenii serovar Tarassovi ≥ 500x106 organisms/mL (as formol cultures). 0.1mg/mL Thiomersal added.

Formulation Type: Aqueous suspension

Application method/administration route:

Cattle: 2 mL Inject subcutaneously (just under the skin). Two doses should be given, 4–6 weeks apart. A booster dose every 12 months is required to maintain the protective level of immunity. Calves less than 3 months of age at the time of the second vaccination should receive a single booster dose 6 months later. This booster may be used to align calves vaccinated “out of season” (i.e. when young, or in a town supply herd) with the annual herd booster. Calves greater than 3 months of age at the time of the second vaccination require an annual booster.

Use Claim:

For the prevention of leptospirosis in cattle caused by Leptospira borgpetersenii serovar Tarassovi and the serovar Tarassovi Pacifica strain. For the prevention of urinary shedding of the named leptospires in cattle when used prior to natural challenge and to prevent the risk of human leptospiral infection associated with shedding of the named leptospires in the urine of cattle.

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:

Zoetis New Zealand Limited, Level 4, 8 Mahuhu Crescent, Auckland Central, Auckland 1010, New Zealand. Postal Address: Zoetis New Zealand Limited, PO Box 2094, Shortland Street, Auckland 1140, New Zealand.

Dated at Wellington this 11th day of April 2025.

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