Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI ACVM 62)
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: Milbemax Tablets
Reference: A008273
Active Ingredients and Concentrations:
Milbemax Tablets for Small Dogs: Each tablet contains 25mg PRAZIQUANTEL and 2.5mg MILBEMYCIN OXIME. Milbemax Tablets for Dogs: Each tablet contains 125mg PRAZIQUANTEL and 12.5mg MILBEMYCIN OXIME.
Formulation Type: Tablet
Application method/administration route: Oral
General Use Claim:
Treatment and control of roundworm, whipworm, hookworm and tapeworm. Efficacy against the hookworm Uncinaria stenocephala has not been established. MILBEMAX Tablets for small dogs should be administered orally to puppies at 2, 4, 8 and 12 weeks of age, then 3 monthly. MILBEMAX Tablets for dogs should be administered to dogs weighing over 5 kg. Nursing bitches should be treated at the same time as their puppies. Adult dogs should be treated four times per year i.e., every 3 months. Pregnant bitches should be treated at mating, then 10 days before whelping, then at the same times as puppies. If worm problems persist, consult a veterinarian. In hydatid tapeworm areas, dogs should be dosed monthly or on veterinary advice.
Proposed New Claim:
Treatment and control of roundworms, whipworm, hookworms and tapeworm. Efficacy against the hookworm Uncinaria stenocephala has not been established. MILBEMAX Tablets for dogs should be administered orally to puppies at 2, 4, 6, 8, 10 and 12 weeks of age, then 3 monthly. MILBEMAX Tablets for dogs should be administered to dogs weighing over 5kg. Pregnant bitches should be treated at mating, then 10 days before whelping, then at the same times as puppies. Nursing bitches should be treated at the same time as their puppies. Deworming frequency should always be tailored according to veterinary advice, which takes into account various factors, such as worm pressure, zoonotic risk, underlying disease etc. If worm problems persists, consult a veterinarian.
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:
Elanco Australasia Pty Ltd, 27/88 Shortland Street, Auckland 1010. Postal Address: 7 Eden Park Drive, Macquarie Park, New South Wales 2113, Australia.
Dated at Wellington this 23rd day of January 2025.
SHALEEN NARAYAN, Ministry for Primary Industries (acting under delegated authority).