Notice of Application to Register a Trade Name Product (Notice No. MPI ACVM 5)
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
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:
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:
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).