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.
Questions and answers on refusal of the marketing authorisation for Aplidin (plitidepsin) (PDF/72.03 KB)Adopted
First published: 20/12/2017
Last updated: 23/03/2018
|International non-proprietary name (INN) or common name||
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|Anatomical therapeutic chemical (ATC) code||
Pharma Mar, S.A.
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|Date of refusal of marketing authorisation||