EMA
- Application: EMEA/H/C/005558
- Marketing authorisation holder: Biogen Netherlands B.V.
- Local brand name: Aduhelm
- Status: withdrawn
🇪🇺 Aduhelm in European Union
Aduhelm (ADUCANUMAB) regulatory status in European Union.
Marketing authorisation
Aduhelm 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 Aduhelm approved in European Union?
Yes. EMA has authorised it.
Who is the marketing authorisation holder for Aduhelm in European Union?
Biogen Netherlands B.V. holds the EU marketing authorisation.