Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI ACVM 61)
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 Names: |
Registration Numbers: |
Active ingredient(s) and its concentration(s): |
Milbemax Tablets for Small Cats |
A008315 |
Each tablet contains 10mg PRAZIQUANTEL and 4mg MILBEMYCIN OXIME |
Milbemax Tablets for Cats |
A008316 |
Each tablet contains 40mg PRAZIQUANTEL and 16mg MILBEMYCIN OXIME |
Formulation type: Tablet |
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Application method/administration route: Oral |
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Existing use claim: For the treatment and control of roundworm, hookworm and tapeworm, and the prevention of heartworm* in cats. For control of gastrointestinal worms: MILBEMAX Tablets for Small Cats should be administered orally to kittens at 6, 8 and 12 weeks of age, then every 3 months. MILBEMAX Tablets for Cats should be administered to cats weighing over 2kg. Nursing queens should be treated at the same time as their kittens. Adult cats should be treated every 3 months. * Not present in New Zealand. Proposed new claim (changes in bold): For the treatment and control of roundworms, hookworms and tapeworms, and the prevention of heartworm* in cats. For control of gastrointestinal worms: MILBEMAX Tablets for Small Cats should only be administered orally to kittens at 6, 8, 10 and 12 weeks of age, then monthly or 3 monthly, depending on worm pressure and risk to human health. MILBEMAX Tablets for Cats should be administered to cats over 2kg. Nursing queens should be treated at the same time as their kittens. In certain situations, adult cats may need to be dewormed more frequently against gastrointestinal worms, e.g., every 2 weeks in areas with high hookworm contamination. 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 persist, consult a veterinarian. * Not present in New Zealand. |
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 14th day of January 2025.
SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).