After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse marketing authorisation for the medicine Gamifant. The medicine was intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age.
The Agency issued its opinion after re-examination on 12 November 2020, following its initial opinion on 23 July 2020. The company that applied for authorisation of Gamifant is Swedish Orphan Biovitrum AB (publ).
Questions and answers on the refusal of the marketing authorisation for Gamifant (emapalumab) (PDF/114.05 KB)
First published: 24/07/2020
Last updated: 19/03/2021
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Immune System Diseases
|Anatomical therapeutic chemical (ATC) code||
Swedish Orphan Biovitrum AB (publ)
|Date of opinion||
|Date of refusal of marketing authorisation||