EMA
- Application: EMEA/H/C/004119
- Local brand name: Besponsa
- Status: approved
INOTUZUMAB OZOGAMICIN (INOTUZUMAB OZOGAMICIN) 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.
Marketing authorisation holder not available in our data.