EMA
- Application: EMEA/H/C/004741
- Marketing authorisation holder: Iovance Biotherapeutics B.V.
- Local brand name: Amtagvi
- Indication: Treatment of unresectable or metastatic melanoma
- Pathway: ATMP
- Status: withdrawn
🇪🇺 LIFILEUCEL in European Union
LIFILEUCEL (LIFILEUCEL) regulatory status in European Union.
Marketing authorisation
LIFILEUCEL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is LIFILEUCEL approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for LIFILEUCEL in European Union?
Iovance Biotherapeutics B.V. holds the EU marketing authorisation.