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Friday, February 6, 2015

European Commission Approves Additional Indication for VELCADEA (bortezomib) in Mantle Cell Lymphoma

Janssen-Cilag International NV announced today that the European Commission has approved a variation to the terms of the marketing authorisation of VELCADEA in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for blood stem-cell transplantation. The decision from the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency on .[1] This approval allows for the marketing of VELCADE for the above indication in all 28 countries of the European Union .

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