By its judgment of 28 October 2020 in case T-594/18, the General Court annulled the Commission Implementing Decision refusing marketing authorisation for Aplidin. As a result, the European Commission has returned the marketing authorisation application for Aplidin to the Agency. EMA is now taking the necessary steps to implement the judgment of the Court.

This EPAR was last updated on 26/11/2020

Authorisation details

Product details
Agency product number

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Product information

Aplidin - EMEA/H/C/004354 -


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

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