EU/3/13/1221

About

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in May 2017 on request of the Sponsor.

On 16 January 2014, orphan designation (EU/3/13/1221) was granted by the European Commission to Chugai Pharma Europe Ltd, United Kingdom, for humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa for the treatment of haemophilia A.

The sponsorship was transferred to Roche Registration Limited, United Kingdom, in December 2014.

This medicine is now known as emicizumab.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa (emicizumab)
Disease / condition
Treatment of haemophilia A
Date of first decision
16/01/2014
Outcome
Withdrawn
EU designation number
EU/3/13/1221

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Tel. +44 (0)1707 362840
Fax +44 (0)1707 377838
E-mail: info.orphan@roche.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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