EU/3/14/1333

About

Please note that this product (marketed as Orkambi) was withdrawn from the Community Register of designated orphan medicinal products in October 2015 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 22 August 2014, orphan designation (EU/3/14/1333) was granted by the European Commission to Vertex Pharmaceuticals (U.K.) Limited, United Kingdom, for lumacaftor/ivacaftor for the treatment of cystic fibrosis.

Key facts

Active substance
  • Lumacaftor
  • ivacaftor
Medicine name
Orkambi
Disease / condition
Treatment of cystic fibrosis
Date of first decision
22/08/2014
Outcome
Withdrawn
EU designation number
EU/3/14/1333

Review of designation

Please note that this product (marketed as Orkambi) was withdrawn from the Community Register of designated orphan medicinal products in October 2015 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

Sponsor's contact details

Vertex Pharmaceuticals (U.K.) Limited
Cardinal Point
Park Road
Rickmansworth
Hertfordshire WD3 1RE
United Kingdom
Tel. +44 (0)1923 432655
Fax +44 (0)1923 432870
E-mail: vertexmedicalinfo@vrtx.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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