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www.fdanews.com/articles/174180-the-medicines-company-wins-marketing-authorization-for-ionsys

The Medicines Company Wins Marketing Authorization for Ionsys

November 20, 2015

The European Commission has granted marketing authorization to The Medicines Company for Ionsys, a patient-controlled, preprogrammed iontophoretic transdermal delivery system with the active ingredient fentanyl.

The product is designed for the management of acute moderate-to-severe, postoperative pain in hospitalized adult patients.

The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on the product in September.

The marketing authorization is valid for the entire European Economic Area. The product also is commercially available in the U.S. — Michael Cipriano