EU/3/12/1054

About

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.

Key facts

Active substance
Obinutuzumab
Medicine name
Gazyvaro
Disease / condition
Treatment of chronic lymphocytic leukaemia
Date of first decision
10/10/2012
Outcome
Positive
EU designation number
EU/3/12/1054

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.

Sponsor's contact details

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Tel. +49 7624 142892
Fax +49 7624 1015
E-mail: global.eu_regulatory_office@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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