EMA — authorised 30 November 1995
- Marketing authorisation holder: Bayer AG
- Status: approved
🇪🇺 Betaseron in European Union
EMA authorised Betaseron on 30 November 1995
Marketing authorisation
Betaseron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in European Union
Frequently asked questions
Is Betaseron approved in European Union?
Yes. EMA authorised it on 30 November 1995.
Who is the marketing authorisation holder for Betaseron in European Union?
Bayer AG holds the EU marketing authorisation.