EU/3/17/1919

About

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in July 2018 on request of the Sponsor.

On 16 October 2017, orphan designation (EU/3/17/1919) was granted by the European Commission to Roche Registration Limited, United Kingdom, for bitopertin for the treatment of beta thalassaemia intermedia and major.

The sponsorship was transferred to Roche Registration GmbH, Germany, in May 2018.

Key facts

Active substance
Bitopertin
Disease / condition
Treatment of beta-thalassaemia intermedia and major
Date of decision
16/10/2017
Outcome
Withdrawn
Orphan decision number
EU/3/17/1919

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 GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Tel. +49 (0) 7624 142892
E-mail: global.eu_regulatory_office@roche.com

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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