Go back to the Europarl portal

Choisissez la langue de votre document :

  • bg - български
  • es - español
  • cs - čeština
  • da - dansk
  • de - Deutsch
  • et - eesti keel
  • el - ελληνικά
  • en - English (Selected)
  • fr - français
  • ga - Gaeilge
  • hr - hrvatski
  • it - italiano
  • lv - latviešu valoda
  • lt - lietuvių kalba
  • hu - magyar
  • mt - Malti
  • nl - Nederlands
  • pl - polski
  • pt - português
  • ro - română
  • sk - slovenčina
  • sl - slovenščina
  • fi - suomi
  • sv - svenska
Parliamentary questions
16 March 2018
E-000208/2018
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission would like to inform the Honourable Member that on 3 January 2018 the applicant for a marketing authorisation of the medicinal product Aplidin (plitidepsin), Pharma Mar, S.A., requested a re-examination of the opinion of the Committee for Medicinal Products for Human Use (CHMP) which was adopted on 14 December 2017. The CHMP in its plenary meeting in January 2018 appointed re-examination rapporteurs and noted the draft re-examination timetable. The re-examination opinion is expected to be adopted in April 2018.

Some information on the CHMP's initial assessment of Aplidin is available in the European Medicines Agency (EMA) website(1). The Commission is not in a position to disclose elements of the ongoing assessment. Following receipt of the CHMP's final opinion, a Commission decision will be adopted. As for all medicinal products, after adoption of the Commission decision, the EMA will publish standard documents related to the assessment on its website.

Decisions on a marketing authorisation of a medicinal product may differ between different jurisdictions, because of different legal requirements and the scientific evaluation being independent from each other.

(1)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004354/smops/Negative/human_smop_001242.jsp&mid=WC0b01ac058001d127

Last updated: 20 March 2018Legal notice