EU/3/07/471: Orphan designation for the treatment of hereditary factor X deficiency

Human coagulation factor X


On 14 September 2007, orphan designation (EU/3/07/471) was granted by the European Commission to Bio Products Laboratory, United Kingdom, for human coagulation factor X for the treatment of hereditary factor X deficiency.

Update: human coagulation factor X (Coagadex) has been authorised in the EU since 16 March 2016. Coagadex is a blood coagulation factor indicated for treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.

The sponsorship was transferred to BPL Bioproducts Laboratory GmbH, Germany, in March 2019.

Key facts

Active substance
Human coagulation factor X
Intended use
Treatment of hereditary factor X deficiency
Orphan designation status
EU designation number
Date of designation

BPL Bioproducts Laboratory GmbH
Dornhofstrasse 34
63263 Neu-Isenburg 
Tel. + 49 6102 812324

Review of designation

During its meeting of 16 to 18 February 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/471 for Coagadex (human coagulation factor X) as an orphan medicinal product for the treatment of hereditary factor X deficiency. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with hereditary factor X deficiency. The COMP recommended that the orphan designation of the medicine be maintained*.

*The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Coagadex (human coagulation factor X) for the treatment of hereditary factor X deficiency (PDF/79.37 KB)


    First published: 05/04/2016
    Last updated: 05/04/2016

  • 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:

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