EMA — authorised 21 June 2013
- Status: approved
🇪🇺 Stendra in European Union
EMA authorised Stendra on 21 June 2013
Marketing authorisations
EMA — authorised 21 June 2013
- Application: EMEA/H/C/002581
- Marketing authorisation holder: Menarini International Operations Luxembourg S.A.
- Local brand name: Spedra
- Indication: Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.
- Status: approved
Stendra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in European Union
Frequently asked questions
Is Stendra approved in European Union?
Yes. EMA authorised it on 21 June 2013; EMA authorised it on 21 June 2013.
Who is the marketing authorisation holder for Stendra in European Union?
Vivus Llc is the originator. The local marketing authorisation holder may differ — check the official source linked above.