EMA — authorised 18 August 2021
- Marketing authorisation holder: MYLAN IRELAND LIMITED
- Status: approved
🇪🇺 Gilenya in European Union
EMA authorised Gilenya on 18 August 2021
Marketing authorisation
Gilenya 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 Gilenya approved in European Union?
Yes. EMA authorised it on 18 August 2021.
Who is the marketing authorisation holder for Gilenya in European Union?
MYLAN IRELAND LIMITED holds the EU marketing authorisation.