EMA
- Application: EMEA/H/C/006451
- Marketing authorisation holder: Amgen Europe B.V.
- Local brand name: Imdylltra
- Indication: Treatment of extensive-stage small cell lung cancer
- Pathway: orphan
- Status: approved
🇪🇺 Imdelltra (Amg757) in European Union
Imdelltra (Amg757) (TARLATAMAB) regulatory status in European Union.
Marketing authorisation
Imdelltra (Amg757) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Imdelltra (Amg757) approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Imdelltra (Amg757) in European Union?
Amgen Europe B.V. holds the EU marketing authorisation.