ropeginterferon alfa-2b

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 25/01/2023

Authorisation details

Product details
Agency product number
Active substance
ropeginterferon alfa-2b
International non-proprietary name (INN) or common name
ropeginterferon alfa-2b
Therapeutic area (MeSH)
Polycythemia Vera
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
AOP Orphan Pharmaceuticals GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Leopold-Ungar-Platz 2
1190 Vienna

Product information

17/11/2022 Besremi - EMEA/H/C/004128 - II/0021

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

Assessment history

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