On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masiviera, intended for the treatment of advanced inoperable pancreatic cancer. 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 22 May 2014.
Questions and answers on refusal of the marketing authorisation for Masiviera (PDF/66.7 KB)Adopted
First published: 23/01/2014
Last updated: 23/05/2014
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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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