On 9 December 2011, orphan designation (EU/3/11/932) was granted by the European Commission to AOP Orphan Pharmaceuticals AG, Austria, for pegylated proline-interferon alpha-2b for the treatment of polycythaemia vera.
Please note that this product (marketed as Besremi) was withdrawn from the Community Register of designated orphan medicinal products in December 2018 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
This medicine is now known as ropeginterferon alfa-2b.
Pegylated proline-interferon alpha-2b (ropeginterferon alfa-2b)
|Disease / condition||
Treatment of polycythaemia vera
|Date of first decision||
|EU designation number||
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Besremi at the time of marketing authorisation.
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the Besremi - Withdrawal assessment report orphan maintenance
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;