EMA — authorised 20 November 2014
- Marketing authorisation holder: Boehringer Ingelheim International GmbH
- Status: approved
EMA authorised Ofev on 20 November 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 20 November 2014.
Boehringer Ingelheim International GmbH holds the EU marketing authorisation.