The DIRECTOR GENERAL Saw art. September 30, 2003 48 of Decree-Law n. 269, converted into law no 326 November 24, 2003, establishing the Italian medicines agency, and as amended and supplemented; Having regard to the Decree of the Minister of health in consultation with the Ministers for public administration and Economics and finance dated September 20, 2004, n. 245 laying down rules on the organisation and the functioning of the Italian Medicines Agency, pursuant to paragraph 13 of article. the aforementioned 48 as amended by order No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and Finance of the March 29, 2012; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register «simple» Visas, sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; View the determination with which the company Ariadne Pharma Ltd (United Kingdom) has obtained the authorisation for the medicinal product ICLUSIG (ponatinib); Having regard to the Commission report No 33 scientific technique of the 19-20 and January 21, 2015, which approves the regime change of supply from OSP to RNRL of medicinal product ICLUSIG;
Causes: Art. 1 Review provision To medicinal product ICLUSIG (ponatinib), the following provision applies: medicinal product subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialist-oncologist, hematologist, internist (RNRL). Negotiating conditions remain unchanged.