The European Medicines Agency has recommended the refusal of the marketing authorisation for Gamifant, a medicine intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age.
The Agency issued its opinion on 23 July 2020. The company that applied for authorisation, Swedish Orphan Biovitrum AB (publ), may ask for re-examination of the opinion within 15 days of receiving the opinion.
|Agency product number||
|International non-proprietary name (INN) or common name||
Immune System Diseases
|Date opinion adopted||