EU/3/12/1054: Orphan designation for the treatment of chronic lymphocytic leukaemia
Table of contents
On 10 October 2012, orphan designation (EU/3/12/1054) was granted by the European Commission to Roche Registration Limited, United Kingdom, for obinutuzumab for the treatment of chronic lymphocytic leukaemia.
Obinutuzumab for treatment of chronic lymphocytic leukaemia has been authorised in the EU as Gazyvaro since 23 July 2014.
The sponsorship was transferred to Roche Registration GmbH, Germany in February 2018.
Treatment of chronic lymphocytic leukaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
Roche Registration GmbH
Review of designation
During its meeting of 10 to 12 June 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/12/1054 for Gazyvaro (obinutuzumab) as an orphan medicinal product for the treatment of chronic lymphocytic leukaemia (CLL). 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 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 CLL. The COMP recommended that the orphan designation of the medicine be maintained1.
1 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
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Gazyvaro (obinutuzumab) for the treatment of chronic lymphocytic leukaemia (PDF/79.32 KB)
First published: 22/08/2014
Last updated: 22/08/2014
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.
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: