EMA
- Application: EMEA/H/C/006673
- Marketing authorisation holder: Pharma Mar S.A.
- Local brand name: Zepzelca
- Indication: Maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
- Pathway: orphan
- Status: approved
🇪🇺 Zepzelca in European Union
Zepzelca (Zepzelca) regulatory status in European Union.
Marketing authorisation
Zepzelca 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 Zepzelca approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Zepzelca in European Union?
Pharma Mar S.A. holds the EU marketing authorisation.