EU/3/07/467

About

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in January 2012 on request of the sponsor.

On 3 August 2007, orphan designation (EU/3/07/467) was granted by the European Commission to GlaxoSmithKline Research & Development Limited, United Kingdom, for eltrombopag olamine for the treatment of idiopathic thrombocytopenic purpura (ITP). The sponsorship was transferred to GlaxoSmithKline Trading Services Limited, Ireland, in August 2008.

Eltrombopag olamine has been authorised in the EU as Revolade since 11 March 2010.

Key facts

Active substance
Eltrombopag olamine
Medicine name
Revolade
Disease / condition
Treatment of idiopathic thrombocytopenic purpura
Date of decision
03/08/2007
Outcome
Withdrawn
Orphan decision number
EU/3/07/467

Review of designation

Please note that this product (marketed as Revolade) was withdrawn from the Community register of designated orphan medicinal products in January 2012 on request of the sponsor, after the granting of a marketing authorisation.

During its meeting of 5-6 January 2010, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/467 for Revolade (eltrombopag olamine) as an orphan medicinal product for the treatment of idiopathic thrombocytopenic purpura. 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 and prevalence of the condition and the existence of other satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. 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

GlaxoSmithKline Trading Services Limited
6900 Cork Airport Business Park
Kinsale Road
Cork
Ireland
Tel. +353 215 004 600
Fax +353 215 004 699

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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