Merck Animal Health Receives Positive Opinion from European Medicines Agency for BRAVECTO™ (fluralaner)
17 December 2013
New Chewable Tablet Treatment for Fleas and Ticks in Dogs – Effective For 12 Weeks
(8 weeks forRhipicephalus sanguineus ticks)
SUMMIT, N.J., December, 17 2013 – Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorization for the veterinary medicinal product BRAVECTO™ (fluralaner) chewable tablets for dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg).
The active substance of BRAVECTO, fluralaner, a new ectoparasiticide belonging to the isoxazoline group, is systemically active against fleas and ticks. The benefits of BRAVECTO are its efficacy in the treatment of flea and tick infestations in dogs. The most common side effects are mild and transient gastrointestinal effects.
If adopted, approved indication:
BRAVECTO will be indicated for the treatment of tick and flea infestation on dogs. It is a systemic insecticide and acaricide that provides:
- Immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks
- Immediate and persistent tick killing activity for 12 weeks (Ixodes ricinus, Dermacentor reticulatus and Dermacentor variabilis)
- Immediate and persistent tick killing activity for 8 weeks (Rhipicephalus sanguineus)
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus). The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatits (FAD).
Detailed conditions of the product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available after the marketing authorization has been granted by the European Commission.
About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.
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