Maree Zinzley, Manager Approvals Operations of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: Bravecto

Reference: A011019

Active Ingredient and Concentrations:

Fluralaner 112.5mg for very small dogs (2–4.5kg)
Fluralaner 250mg for small dogs (>4.5–10kg)
Fluralaner 500mg for medium-sized dogs (>10–20kg)
Fluralaner 1000mg for large dogs (>20–40kg)
Fluralaner 1400mg for very large dogs (>40–56kg)

Formulation Type: Tablet (chewable)

General Use Claim:

For the control of tick and flea infestations on dogs for twelve weeks.

• Treats and controls existing flea and tick infestations.

• Sustained control of new flea and tick infestations for twelve weeks.

• Treatment of Demodicosis caused by Demodex spp. mites.

• Safe for use in breeding, pregnant and lactating dogs.

• Controls immature stages of fleas and ticks.

• Aids in the control of flea allergy dermatitis.

Proposed Variation to Conditions:

For the control of flea and tick infestations on dogs.

• Treats and controls existing flea and tick infestations.

• Sustained control of new flea and tick infestations for three months.

• Treatment and control of Demodicosis caused by Demodex spp. mites.

• Treatment and control of Otodectes and Sarcoptes spp. mites.

• Safe for use in MDR1 breeds.

• Safe for use in breeding, pregnant and lactating dogs.

• Part of a treatment strategy for the control of flea allergy dermatitis.

• Highly effective against fipronil resistant fleas.

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; and
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 notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

1. where submissions on this application are to be sent; and
2. where requests for copies of the public information relating to the application can be sent; and
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

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 2nd day of August 2016.

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