CHMP recommends approval of rituximab (MabThera®) for granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis

Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a new indication for rituximab (MabThera®) - for use in combination with glucocorticoids, for the induction of remission in adult patients with severe, active Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA).   Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) after the variation to the marketing authorisation has been granted by the European Commission.
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news