The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. September 30, 2003 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency and, in particular, paragraph 13; 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. 48 above, and in particular art. 19; 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 "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; Having regard to the Decree of the Minister of health September 28, 2004 which formed the technical and Scientific Advisory Committee of the Italian Medicines Agency; Having regard to law no December 23, 1996. 648, conversion of Decree Law No 536 October 21, 1996 concerning measures for the containment of pharmaceutical expenditure and determining the expenditure ceiling for the year 1996, published in the Official Gazette No. 300 of December 23, 1996; Having regard to the Commission's decision only (CUF) dated July 20, 2000, published in the Official Journal No. 219 of September 19, 2000 with errata in Official Gazette No. 232 of October 4, 2000, concerning the establishment of the list of innovative medicines whose marketing is authorized in other States but not on the national territory, of medicinal products which have not yet permitted but subjected to clinical trials and medicines to be used for a therapeutic indication other than that authorised, to be the sole responsibility of the national health service where there is no valid alternative therapy in accordance with art. 1, paragraph 4, of Decree Law October 21, 1996 # 536, converted by law December 23, 1996 # 648; Having regard to the Italian medicines agency determination December 18, 2014, published in Official Gazette No. 5 of January 8, 2015 concerning the regime of new listings and price of the medicine Soliris (Eculizumab) for the statement "treat patients with hemolytic uremic syndrome (ahus); Was therefore considered to exclude from the list of medicinal products granted sole responsibility of national health service established under the Act December 23, 1996, n. Soliris (Eculizumab) for the medicinal 648 ' treatment of atypical Hemolytic Uremic Syndrome (HUS)» entered in that list June 7, 2011 with determination of the Italian medicines agency, published in the Official Journal No. 141 of the June 20, 2011;
Causes: Art. 1 the drug Soliris (Eculizumab) is excluded for the words ' treatment of atypical Hemolytic Uremic Syndrome (HUS) "from the list of medicinal products granted sole responsibility of national health service established under law No 648/96.