EU/3/10/847: Orphan designation for the treatment of haemophilia A

Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol)


Please note that this product (marketed as Jivi) was withdrawn from the Community Register of designated orphan medicinal products in October 2018 upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.

On 23 February 2011, orphan designation (EU/3/10/847) was granted by the European Commission to Bayer Schering Pharma AG, Germany, for pegylated B-domain-deleted sequence-modified recombinant human factor VIII for the treatment of haemophilia A.

Bayer Shering Pharma AG changed its name to Bayer Pharma AG in October 2011.

The sponsorship was transferred to Bayer AG, Germany, in August 2017.

This medicine is now known as damoctocog alfa pegol.

Key facts

Active substance
Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol)
Intended use
Treatment of haemophilia A
Orphan designation status
EU designation number
Date of designation

Bayer AG
51368 Leverkusen
Tel. +49 30 300 139 003

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Jivi 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 icon Jivi : Withdrawal orphan maintenance assessment report

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:

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