EMA — authorised 13 June 2022
- Marketing authorisation holder: ALNYLAM NETHERLANDS B.V.
- Status: approved
🇪🇺 Amvuttra in European Union
EMA authorised Amvuttra on 13 June 2022
Marketing authorisations
EMA — authorised 15 September 2022
- Application: EMEA/H/C/005852
- Marketing authorisation holder: Alnylam Netherlands B.V.
- Local brand name: Amvuttra
- Indication: Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
- Pathway: orphan
- Status: approved
Amvuttra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Amvuttra approved in European Union?
Yes. EMA authorised it on 13 June 2022; EMA authorised it on 15 September 2022.
Who is the marketing authorisation holder for Amvuttra in European Union?
ALNYLAM NETHERLANDS B.V. holds the EU marketing authorisation.