EMA — authorised 13 November 2013
- Marketing authorisation holder: GlaxoSmithKline (Ireland) Limited
- Status: approved
🇪🇺 Breo Ellipta in European Union
EMA authorised Breo Ellipta on 13 November 2013
Marketing authorisation
Breo Ellipta 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 Breo Ellipta approved in European Union?
Yes. EMA authorised it on 13 November 2013.
Who is the marketing authorisation holder for Breo Ellipta in European Union?
GlaxoSmithKline (Ireland) Limited holds the EU marketing authorisation.