EU/3/12/1004: Orphan designation for the treatment of gastric cancer

Ramucirumab

Overview

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2015 on request of the sponsor.

On 4 July 2012, orphan designation (EU/3/12/1004) was granted by the European Commission to Eli Lilly Nederland B.V., the Netherlands, for ramucirumab for the treatment of gastric cancer.

Ramucirumab has been authorised in the EU as Cyramza since 19 December 2014.

Key facts

Active substance
Ramucirumab
Medicine name
Cyramza
Intended use
Treatment of gastric cancer
Orphan designation status
Withdrawn
EU designation number
EU/3/12/1004
Date of designation
04/07/2012
Sponsor
Eli Lilly Nederland B.V.
Grootslag 1-5
3991 Houten
The Netherlands
Tel. +31 3060 25800
Fax +31 3060 25888
E-mail: eu_orphan@lilly.com

Review of designation

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2015 on request of the sponsor.


During its meeting of 11-13 November 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/12/1004 for Cyramza (ramucirumab) as an orphan medicinal product for the treatment of gastric cancer. 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 gastric cancer. The COMP recommended that the orphan designation of the medicine be maintained*.


*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

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cyramza (ramucirumab) for the treatment of gastric cancer (PDF/84.33 KB)

    Adopted

    First published: 30/01/2015
    Last updated: 30/01/2015
    EMA/601520/2014

  • 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.

    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:

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