Gamifant

emapalumab

Table of contents

Opinion

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.

Key facts

Name
Gamifant
Agency product number
EMEA/H/C/004386
International non-proprietary name (INN) or common name
  • emapalumab
Active substance
  • Emapalumab
Therapeutic area
Immune System Diseases
Date opinion adopted
23/07/2020
Company name
Swedish Orphan Biovitrum AB (publ)
Status
Negative
Application type
Initial authorisation

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