Basic Information
Besremi
Regulatory Information
EMEA/H/C/004128
February 15, 2019
February 15, 2019
7
April 9, 2025
Company Information
Austria
Leopold-Ungar-Platz 2 1190 Vienna
AOP Orphan Pharmaceuticals GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Overview Summary
Besremi is a medicine used to treat polycythaemia vera in adults who do not have symptoms of an enlarged spleen. In patients with polycythaemia vera, the body produces too many red blood cells, which can cause the blood to thicken and reduce blood flow to the organs. The patients’ spleen may also become larger as it tries to remove excess cells. Polycythaemia vera is rare, and Besremi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2011. Besremi contains the active substance ropeginterferon alfa-2b.