🇪🇺 NI-0501 in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

NI-0501 (NI-0501) regulatory status in European Union.

Marketing authorisation

EMA

Application: EMEA/H/C/004386
Marketing authorisation holder: Swedish Orphan Biovitrum AB (publ)
Local brand name: Gamifant
Indication: Gamifant is indicated for the treatment of paediatric patients aged under 18 years with primary haemophagocytic lymphohistiocytosis (HLH).
Pathway: orphan, PRIME
Status: rejected

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Frequently asked questions

Is NI-0501 approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for NI-0501 in European Union?

Swedish Orphan Biovitrum AB (publ) holds the EU marketing authorisation.