Dipharma announces grant of centralised marketing authorization for generic Miglustat in Europe
Chiasso, Switzerland, February 20th, 2019 – – Dipharma S.A. (“Dipharma”) today announced that the European Commission has granted Marketing Authorization of its generic Miglustat. This authorization comes after CHMP positive opinion last December in the frame of a centralized procedure at European Medicine Agency. Miglustat Dipharma 100 mg capsules has thus received authorization for all the 31 countries of the European Economic Area.
Miglustat Dipharma is a generic equivalent to Actelion’s (Johnson & Johnson) Zavesca®, and it can be stored at room temperature for 36 months. Dipharma owns IP rights on the Miglustat active substance, notably in U.S. and Europe.