CHMP recommends approval of Imatinib Actavis

Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the granting of a marketing authorisation for Imatinib Actavis for the treatment of:   . Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.   . Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.   . Adult patients with Ph+ CML in blast crisis.   Imatinib Actavis is a generic of Glivec®, which has been authorised in the EU since November 2001. Studies have demonstrated the satisfactory quality of Imatinib Actavis, and its bioequivalence with the reference product Glivec®.   Detailed recommendations for the use of this product will be described in the Summary of Product ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news