EMA — authorised 16 November 2011
- Status: approved
🇪🇺 Vyndaqel in European Union
EMA authorised Vyndaqel on 16 November 2011
Marketing authorisations
EMA — authorised 16 November 2011
- Application: EMEA/H/C/002294
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Vyndaqel
- Indication: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
- Pathway: exceptional circumstances, orphan
- Status: approved
Vyndaqel 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 Vyndaqel approved in European Union?
Yes. EMA authorised it on 16 November 2011; EMA authorised it on 16 November 2011.
Who is the marketing authorisation holder for Vyndaqel in European Union?
Foldrx Pharms is the originator. The local marketing authorisation holder may differ — check the official source linked above.