On 13 December 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia. The company that applied for authorisation is Genzyme Europe B.V.
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 21 March 2013.
Questions and answers on the refusal of the marketing authorisation for Kynamro - Outcome of re-examination (PDF/142.74 KB)Adopted
First published: 22/03/2013
Last updated: 22/03/2013
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Genzyme Europe BV
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