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 Spot-On Solution
Reference: A011261
Active Ingredient and Concentration:
Fluralaner 280mg/mL
Formulation Type: Vapour releasing product
General Use Claim:
Control of tick and flea infestations on dogs.
-
Immediate and persistent flea (Ctenocephalides sp.) killing activity for six months; and
-
immediate and persistent tick (Haemaphysalis Iongicornis) killing activity for four months.
-
Safe for use in breeding, pregnant and lactating dogs.
-
Safe for use in MDR1 breeds.
-
Controls immature stages of fleas and immature tick stages.
-
Part of a treatment strategy for the control of flea allergy dermatitis.
- Highly effective against fipronil resistant fleas.
Proposed Variation to Conditions:
For the control of flea and tick infestations on dogs.
-
Immediate and persistent flea (Ctenocephalides sp.) killing activity for six months; and
-
immediate and persistent tick (Haemaphysalis longicornis) killing activity for four months.
-
Treatment and control of Otodectes and Sarcoptes spp. mites.
-
Safe for use in breeding, pregnant and lactating dogs.
-
Safe for use in MDR1 breeds.
-
Controls immature stages of fleas and immature tick stages.
-
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).