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: Bravecto Quantum

Registration Number: A011993

Active Ingredients and Concentrations:

1000mg/g FLURALANER. Contains 150mg/mL FLURALANER when suspended according to directions.

Formulation Type: Aqueous suspension

Existing Use Claim:

• For the treatment of existing flea (Ctenocephalides felis) infestations.
• For the control of new flea (Ctenocephalides felis) infestations for 12 months (1 year).
• A single injection will control flea infestations on the dog within 2 days of treatment. From day 6, fleas are killed within 24 hours of infestation before they lay eggs, for a full year.
• Part of a treatment strategy for the control of flea allergy dermatitis (FAD). Fleas must attach to the host and commence feeding in order to be exposed to the active ingredient.
• Long-lasting efficacy controls newly emerged fleas before viable eggs are produced; contributing towards the control of the environmental flea populations in areas to which treated dogs have access.
• Effective against fipronil-resistant strains of fleas.
• Safe for use in MDR1 deficient breeds

Proposed New Claim (changes in bold):

• For the treatment of existing flea (Ctenocephalides felis) and tick (Haemaphysalis longicornis) infestations.
• For the control of new flea (Ctenocephalides felis) and tick (Haemaphysalis longicornis) infestations for 12 months (1 year).
• A single injection will control flea and tick infestations on the dog within 2 days of treatment. From day 6, fleas are killed within 24 hours of infestation before they lay eggs, for a full year. Ticks are killed within 2 days of treatment or infestation, for a full year.
• Part of a treatment strategy for the control of flea allergy dermatitis (FAD). Fleas must attach to the host and commence feeding in order to be exposed to the active ingredient.
• Long-lasting efficacy controls newly emerged fleas before viable eggs are produced; contributing towards the control of the environmental flea populations in areas to which treated dogs have access.
• Effective against fipronil-resistant strains of fleas.
• Safe for use in MDR1 deficient breeds

Other Information: Treatment by subcutaneous injection in dogs over 6 months of age

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 28th day of November 2023.

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