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Monday, 26 May 2014
European Medicines Agency recommends granting a marketing authorisation for obinutuzumab
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product obinutuzumab (Gazyvaro) 1,000 mg concentrate for solution for infusion intended for the treatment in combination with chlorambucil of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. Read more here.
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