EMA — authorised 2 June 1998
- Marketing authorisation holder: Roche Registration GmbH
- Status: approved
EMA authorised Mabthera on 2 June 1998
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 2 June 1998.
Roche Registration GmbH holds the EU marketing authorisation.