Regulatory PathRegulatory requirements compared

Active substance

Ropeginterferon alfa 2b

Open in the medicines table

EMA European Union — centrally authorised medicines

Besremi AOP Orphan Pharmaceuticals GmbH · Authorised · authorised 15 Feb 2019 · ATC L03AB15

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BESREMI02569728500 MCG / 1 MLSOLUTION · SUBCUTANEOUSFORUS THERAPEUTICS INC.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.