EMA — authorised 19 June 2019
- Marketing authorisation holder: L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
- Status: approved
🇪🇺 Subutex in European Union
EMA authorised Subutex on 19 June 2019
Marketing authorisation
Subutex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in European Union
Frequently asked questions
Is Subutex approved in European Union?
Yes. EMA authorised it on 19 June 2019.
Who is the marketing authorisation holder for Subutex in European Union?
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. holds the EU marketing authorisation.