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This medicine was refused authorisation for use in the European Union.
On 3 July 2012, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of a marketing authorisation for the medicinal product Elelyso, intended for the treatment of type 1 Gaucher disease.
Following the CHMP recommendation, on 25 October 2012, the European Commission adopted a decision refusing the granting of a marketing authorisation.
Questions and answers on refusal of the marketing authorisation for Elelyso (PDF/77.21 KB)
First published: 22/06/2012
Last updated: 23/11/2012
This EPAR was last updated on 23/11/2012
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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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