EMA approves marketing authorisation for ponatinib/Iclusig

21 March 2013 EMA/CHMP/178415/2013 Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (initial authorisation) Iclusig Ponatinib On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Iclusig 15 mg and 45 mg film-coated tablets intended for the treatment of chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was