EMA — authorised 15 February 2019
- Marketing authorisation holder: AOP Orphan Pharmaceuticals AG
- Status: approved
🇪🇺 Besremi in European Union
EMA authorised Besremi on 15 February 2019
Marketing authorisations
EMA — authorised 15 February 2019
- Application: EMEA/H/C/004128
- Marketing authorisation holder: AOP Orphan Pharmaceuticals GmbH
- Local brand name: Besremi
- Indication: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
- Status: approved
Besremi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in European Union
Frequently asked questions
Is Besremi approved in European Union?
Yes. EMA authorised it on 15 February 2019; EMA authorised it on 15 February 2019.
Who is the marketing authorisation holder for Besremi in European Union?
AOP Orphan Pharmaceuticals AG holds the EU marketing authorisation.