EU/3/09/640: Orphan designation for the treatment of haemophilia B

Pegylated recombinant human factor IX (nonacog beta pegol)

Table of contents


Please note that this product (marketed as Refixia) was withdrawn from the Community Register of designated orphan medicinal products in May 2017 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 15 May 2009, orphan designation (EU/3/09/640) was granted by the European Commission to Novo Nordisk A/S, Denmark, for pegylated recombinant human factor IX for the treatment of haemophilia B.

This medicine is now known as nonacog beta pegol.

Key facts

Active substance
Pegylated recombinant human factor IX (nonacog beta pegol)
Intended use
Treatment of haemophilia B
Orphan designation status
EU designation number
Date of designation

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Tel. +45 44 44 88 88

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

How useful was this page?

Add your rating