Ropeginterferon alfa-2b

Ropeginterferon alfa-2b (Besremi, AOP Orphan Pharmaceuticals GmbH) has 1 EU-approved indication in 1 tumour type.
Approved indications of Ropeginterferon alfa-2b
Biomarker requirementRegimenSettingConditions
Myeloproliferative neoplasms1
None
Monotherapy
Any line
Polycythaemia vera only; Without symptomatic splenomegaly
Full text of section 4.1 (therapeutic indications)

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

Label history

13 changes to the Besremi label since 2022, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes