EMA makes positive recommendation on extention of Novartis' Glivec

theflyonthewall.com

The Committee for Medicinal Products for Human Use, CHMP, adopted a positive opinion recommending a variation to the terms of the marketing authorization for Glivec, held by Novartis Europharm. The CHMP adopted a new indication as follows: "Glivec is indicated for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.”

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