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On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST). The company that applied for authorisation is AB Science.
The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014.
Questions and answers on refusal of the marketing authorisation for Masican (PDF/88.88 KB)Adopted
First published: 22/11/2013
Last updated: 21/03/2014
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Gastrointestinal Stromal Tumors
|Anatomical therapeutic chemical (ATC) code||
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.
|Date of opinion||
|Date of refusal of marketing authorisation||