EMA — authorised 21 August 2020
- Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
- Status: approved
🇪🇺 Symdeko (Copackaged) in European Union
EMA authorised Symdeko (Copackaged) on 21 August 2020
Marketing authorisation
Symdeko (Copackaged) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in European Union
Frequently asked questions
Is Symdeko (Copackaged) approved in European Union?
Yes. EMA authorised it on 21 August 2020.
Who is the marketing authorisation holder for Symdeko (Copackaged) in European Union?
Vertex Pharmaceuticals (Ireland) Limited holds the EU marketing authorisation.