EU/3/18/1994

About

On 21 March 2018, orphan designation (EU/3/18/1994) was granted by the European Commission to QRC Consultants Ltd, United Kingdom, for ivosidenib for the treatment of biliary tract cancer.

The sponsorship was transferred to Quality Regulatory Clinical Ireland Limited, in August 2018.

Key facts

Active substance
Ivosidenib
Disease / condition
Treatment of biliary tract cancer
Date of decision
21/03/2018
Outcome
Positive
Orphan decision number
EU/3/18/1994

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Quality Regulatory Clinical Ireland Limited
21 Priory Office Park
Stillorgan
Co. Dublin
Ireland
Tel. +353 1 2100440
E-mail: sarah.nicholson@qrci.ie

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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