Dipharma gains European approval of generic Zavesca

20 February 2019

Swiss generic drugmaker Dipharma today announced that the European Commission has granted Marketing Authorization of its generic miglustat.

This authorization comes after the European Medicines Agency’s the Committee for Medicinal Products for Human Use (CHMP) positive opinion last December in the frame of a centralized procedure. Miglustat Dipharma 100mg capsules has thus received authorization for all the 31 countries of the European Economic Area.

Miglustat Dipharma is a generic equivalent to Johnson & Johnson (NYSE: JNJ) company Actelion’s Zavesca (miglustat), and it can be stored at room temperature for 36 months. Dipharma owns IP rights on the miglustat active substance, notably in the USA and Europe.

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