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.
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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.
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
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