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: Bravecto FMP Chew

Reference: A012107

Active Ingredients and Concentrations:

25mg fluralaner / 0.0625mg moxidectin / 12.5mg pyrantel (as embonate)
[50mg fluralaner / 0.125mg moxidectin / 25mg pyrantel (as embonate)]
[100mg fluralaner / 0.25mg moxidectin / 50mg pyrantel (as embonate)]
[200mg fluralaner / 0.5mg moxidectin / 100mg pyrantel (as embonate])
[400mg fluralaner / 1mg moxidectin / 200mg pyrantel (as embonate)]
[600mg fluralaner / 1.5mg moxidectin / 300mg pyrantel (as embonate)]

Formulation Type: Tablet (chewable)

Application method/administration route: For oral use only

Use Claim:

For the control of fleas, ticks and gastrointestinal nematodes in dogs for 1 month

• Treats and controls existing flea (Ctenocephalides felis and C. canis) and tick (Haemaphysalis longicornis) infestations in dogs.
• Provides immediate and persistent flea and tick killing activity for 1 month.
• Indirectly reduces tapeworm (Dipylidium caninum) infection.
• Part of a treatment strategy for the control of flea allergy dermatitis (FAD).
• Treatment and control of demodicosis caused by Demodex spp. mites.
• Treatment and control of Otodectes cynotis mites.
• Treatment of infections with gastrointestinal nematodes of the following species: Roundworms (immature adult (L5) and adult stages of Toxocara canis, and adult stages of Toxascaris leonina) and hookworms (L4, immature adult (L5) and adult stages of Ancylostoma caninum and adult stages of Uncinaria stenocephala)

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:

Schering-Plough Animal Health Limited, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Private Bag 908, Upper Hutt 5140.

Dated at Wellington this 20th day of May 2024.

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