EU/3/12/1004

About

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2015 on request of the sponsor.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
Disease / condition
treatment of gastric cancer
Date of decision
04/07/2012
Outcome
Positive
Orphan decision number
EU/3/12/1004

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Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2015 on request of the sponsor.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

Sponsor's contact details

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

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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