Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to vary the conditions of a registered trade name product under section 9(2) of the Act:

Trade Name: NexGard Spectra Spot-On Solution for Cats

Registration Number: A011852

Active Ingredients and Concentrations:

12 g/L esafoxolaner; 4 g/L eprinomectin; 83 g/L praziquantel

Formulation Type: Non-aqueous solution

Other Information: Change in a safety claim from (changes in bold):

The safe use of NEXGARD SPECTRA SPOT-ON SOLUTION for Cats has not been tested during pregnancy and lactation. However, laboratory studies with the individual ingredients in rats and rabbits have not produced reproductive or developmental abnormalities. Consult your veterinarian.

to:

NEXGARD SPECTRA SPOT-ON SOLUTION for Cats was shown to be safe in various breeds of cats and kittens 8 weeks of age and older, and in breeding, pregnant or lactating queens.

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.

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, 34–38 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:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 3, 2 Osterley Way, Manukau, Auckland 2104. Postal Address: PO Box 76211, Manukau, Auckland 2241.

Dated at Wellington this 23rd day of August 2023.

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