Aplidin

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plitidepsin

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 14 December 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Aplidin, intended for the treatment of multiple myeloma. The company that applied for authorisation is PharmaMar.

The company requested a re-examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 22 March 2018.

This EPAR was last updated on 01/08/2018

Application details

Product details
Name
Aplidin
Active substance
Plitidepsin
International non-proprietary name (INN) or common name
plitidepsin
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01
OrphanOrphan

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.

Application details
Marketing-authorisation applicant
Pharma Mar, S.A.
Date of opinion
14/12/2017
Date of refusal of marketing authorisation
17/07/2018

Assessment history

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