EMA — authorised 9 December 2022
- Marketing authorisation holder: BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- Status: approved
EMA authorised Spevigo on 9 December 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 9 December 2022.
BOEHRINGER INGELHEIM INTERNATIONAL GMBH holds the EU marketing authorisation.