24 May 2016
Merck Animal Health Receives Marketing Approval from European Medicines Agency for BRAVECTO™ (fluralaner) Spot-On Solution for Cats and Dogs
Spot-On Treatment for Fleas and Ticks Effective For 12 Weeks
MADISON, N.J., May 24, 2016 – Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced that, following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Medicine Agency has granted a marketing authorization for the veterinary medicinal product BRAVECTO™ (fluralaner) Spot-On Solution for both cats and dogs, a Spot-On treatment for fleas and ticks effective for 12 weeks following a single dose.
BRAVECTO Spot-On, a systemic insecticide and acaricide, is indicated for the treatment of tick and flea infestations on cats and dogs and provides immediate and persistent flea and tick killing activity for 12 weeks. BRAVECTO Spot-On is applied topically using the new “Twist’n’Use”™ pipette design for ease of application. 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).
“Approval of BRAVECTO Spot-On builds on the strong foundation and body of scientific evidence that we have established with our chewable tablet for dogs, the oral flea and tick product available today,” said KJ Varma, senior vice president, research & development, Merck Animal Health. “BRAVECTO Spot-On now provides veterinarians and cat owners another tool in the fight against parasites and gives veterinarians and dog owners a choice in how to administer flea and tick protection that works quickly and lasts up to twelve weeks.”
In 2014, BRAVECTO was launched as a chewable tablet for dogs. More than 13 million doses of the BRAVECTO chew have been dispensed in 60 countries since its introduction.
Fleas and ticks must attach to the treated animal and commence feeding in order to be exposed to the active substance. The most common side effects of BRAVECTO Spot-On in dogs are mild and transient skin reactions such as erythema or alopecia at the application site and, in cats, pruritus at the application site. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). The most common side effects of BRAVECTO chewable tablet administration to dogs are mild and transient gastrointestinal effects.
BRAVECTO Spot-On will be available in countries throughout Europe in the coming months. Veterinarians interested in learning more about BRAVECTO Spot-On should contact their MSD Animal Health representative.
About Merck Animal Health
For 125 years, Merck has been a global health care 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. Through its commitment to the Science of Healthier Animals™, MSD 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 or connect with us on LinkedIn.
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