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.
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Treats and controls existing flea and tick infestations.
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Sustained control of new flea and tick infestations for twelve weeks.
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Treatment of Demodicosis caused by Demodex spp. mites.
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Safe for use in breeding, pregnant and lactating dogs.
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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.
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Treats and controls existing flea and tick infestations.
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Sustained control of new flea and tick infestations for three months.
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Treatment and control of Demodicosis caused by Demodex spp. mites.
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Treatment and control of Otodectes and Sarcoptes spp. mites.
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Safe for use in MDR1 breeds.
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Safe for use in breeding, pregnant and lactating dogs.
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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:
- must state in full the reasons for making the submission; and
- may state any decision sought on that application; and
- 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:
- where submissions on this application are to be sent; and
- where requests for copies of the public information relating to the application can be sent; and
- where public information relating to the application can be viewed; and
- 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).