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