EU/3/12/1049

About

Please note that this product (marketed as Rubraca) was withdrawn from the Community Register of designated orphan medicinal products in November 2018 upon request of the marketing authorisation holder at the time of the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
Disease / condition
Treatment of ovarian cancer
Date of decision
10/10/2012
Outcome
Withdrawn
Orphan decision number
EU/3/12/1049

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 iconRubraca : Withdrawal assessment report - Orphan maintenance

Sponsor's contact details

Clovis Oncology UK Limited
Sheraton House
Castle Park
Cambridge
CB3 0AX
United Kingdom
Telephone: +44 1223 370037
E-mail: info@clovisoncology.com

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;

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