Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Lympreva
Active substance: dasiprotimut-t
Indication: Lympreva is an active immunotherapy indicated for the treatment of patients with follicular
non-Hodgkin’s lymphoma (FL) as consolidation therapy after achieving complete remission with induction therapy and is co-administered with Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF). For information on the induction therapy used in clinical trials see section 5.1.
Marketing Authorisation Holder: Biovest Europe Limited

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Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
7/07/2015 Centralised - Refusal of marketing authorisation EMEA/H/C/2772 (2015)4710 of 3/07/2015