EU/3/12/1049: Orphan designation for the treatment of ovarian cancer

Rucaparib

Overview

Please note that this product (marketed as Rubraca) was withdrawn from the Community Register of designated orphan medicinal products in November 2018 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 10 October 2012, orphan designation (EU/3/12/1049) was granted by the European Commission to Clovis Oncology UK Limited, United Kingdom, for rucaparib for the treatment of ovarian cancer.

Rucaparib has been authorised in the EU as Rubraca since 24 May 2018.

Key facts

Active substance
Rucaparib
Intended use
Treatment of ovarian cancer
Orphan designation status
Withdrawn
EU designation number
EU/3/12/1049
Date of designation
10/10/2012
Sponsor
Clovis Oncology UK Limited
Sheraton House
Castle Park
Cambridge
CB3 0AX
United Kingdom
Telephone: +44 1223 370037
E-mail: info@clovisoncology.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Rubraca at the time of marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report - orphan maintenance  PDF icon Rubraca : Withdrawal assessment report - Orphan maintenance

Documents related to this orphan designation evaluation

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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