Masican

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masitinib

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

Overview

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.

This EPAR was last updated on 22/11/2013

Application details

Product details
Name
Masican
Active substance
masitinib
International non-proprietary name (INN) or common name
masitinib
Therapeutic area (MeSH)
Gastrointestinal Stromal Tumors
Anatomical therapeutic chemical (ATC) code
L01XE
Orphan

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
Date of opinion
07/05/2014
Date of refusal of marketing authorisation
03/07/2014

Assessment history

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