stappa schreef op 30 april 2017 14:46:
EMA site geeft interessante info. Capla is op 7 maart opgenomen in onderstaande lijst, zie blz 5.
www.ema.europa.eu/docs/en_GB/document...This list only includes information for medicines
whose applications have been validated at the time the report was compiled. The information in this report was compiled on 7 March 2017.
Algemene regel voor goedkeuringstraject COMP (hier valt Capla onder)
In accordance with Article 5.5 of Regulation (EC) No 141/2000, the Committee for Orphan Medicinal Products (COMP) will reach an opinion on a valid application for orphan designation within
90 days.