On 18 May 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 Masipro, intended for the treatment of systemic mastocytosis. The company that applied for authorisation is AB Science.
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 14 September 2017.
Questions and answers on refusal of the marketing authorisation for Masipro (masitinib) (PDF/72.9 KB)Adopted
First published: 19/05/2017
Last updated: 04/04/2018
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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.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 201715/09/2017