Animal Health Firm Granted European Marketing Authorisation for Flea & Tick Prevention

MSD Animal Health (known as Merck Animal Health in 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 final opinion, recommending the granting of a marketing authorization for their veterinary Spot-On for both cats and dogs.

In 2014, MSD Animal Health launched a chew for dogs providing parasite protection with its active ingredient, fluralaner, against fleas and ticks for up to 12 weeks with a single treatment. The animal health firm’s Spot-On provides 12 weeks of flea and tick protection for both cats and dogs with the same active ingredient as the chew.

The Spot-On will be the first product to provide immediate and persistent systemic flea and tick protection for cats and gives veterinarians and dog owners a choice in how to administer flea and tick protection. It can also be used to treat Flea Allergy Dermatitis (FAD) in dogs and also cats.

If adopted, the Spot-On will be indicated for the treatment of tick and flea infestations on cats and dogs. It is a systemic insecticide and acaricide that provides immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks in cats and dogs.

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 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 veterinary Spot-On is applied using the company’s unique “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) and will be available after the marketing authorization has been granted by the European Commission.

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