EMA
- Application: EMEA/H/C/006673
- Local brand name: Zepzelca
- Status: opinion
Zepzelca (LURBINECTEDIN) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Jazz Pharmaceuticals is the originator. The local marketing authorisation holder may differ — check the official source linked above.