Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Besremi   
Auth. number : EU/1/18/1352
Active substance : ropeginterferon alfa-2b
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AB - Interferons
Chemical substance: L03AB15 - ropeginterferon alfa-2b
(See WHO ATC Index)
Indication: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.
Marketing Authorisation Holder: AOP Orphan Pharmaceuticals AG
Wilhelminenstraβe 91/II f, 1160 Wien, Österreich

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/02/2019 Centralised - Authorisation EMEA/H/C/4128/00 (2019)1455 of 15/02/2019