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Pharmaceuticals - Community Register
List of refusals for human medicinal products
|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|
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|07/07/2015||Centralised - Refusal of marketing authorisation||EMEA/H/C/2772||(2015)4710 of 03/07/2015|