EMA — authorised 30 January 2014
- Marketing authorisation holder: BIOGEN NETHERLANDS B.V.
- Status: approved
🇪🇺 Tecfidera in European Union
EMA authorised Tecfidera on 30 January 2014
Marketing authorisation
Tecfidera 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 Tecfidera approved in European Union?
Yes. EMA authorised it on 30 January 2014.
Who is the marketing authorisation holder for Tecfidera in European Union?
BIOGEN NETHERLANDS B.V. holds the EU marketing authorisation.