On 23 April 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lympreva, intended for the treatment of patients with follicular non-Hodgkin’s lymphoma.
The company that applied for authorisation is Biovest Europe Ltd. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Questions and answers on refusal of a change to the marketing authorisation for Lympreva (dasiprotimut-T) (PDF/74.46 KB)Adopted
First published: 24/04/2015
Last updated: 24/04/2015
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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.
Biovest Europe Ltd
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