EU/3/11/932

About

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Please note that this product (marketed as Besremi) was withdrawn from the Community Register of designated orphan medicinal products in December 2018 upon request of the marketing authorisation holder at the time of the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.

Key facts

Active substance
Pegylated proline-interferon alpha-2b (ropeginterferon alfa-2b)
Disease / condition
Treatment of polycythaemia vera
Date of first decision
09/12/2011
Outcome
Withdrawn
EU designation number
EU/3/11/932

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 PDF iconBesremi - Withdrawal assessment report orphan maintenance

Sponsor's contact details

AOP Orphan Pharmaceuticals AG
Wilhelminenstrasse 91/IIf
A-1160 Vienna
Austria
Telephone: +43 1 503 72 44 22
Telefax: +43 1 503 72 44 61
office@aoporphan.at

Patients' organisations

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;

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