Besremi (ropeginterferon alfa-2b)
- Region
- 🇪🇺 EU
- Active substance
- ropeginterferon alfa-2b
- Company
- AOP Orphan Pharmaceuticals GmbH
- Status
- Authorised
- Therapeutic area
- Polycythemia Vera
- CHMP opinion
- Fri 15 Feb 2019
- EU approval
- Fri 15 Feb 2019
- Application
- EMEA/H/C/004128
- ATC
- L03AB15
- Official record
- www.ema.europa.eu
Indication
Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.