Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in July 2018 on request of the Sponsor.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.
|Disease / condition||
Treatment of beta-thalassaemia intermedia and major
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
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;