Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-13&atto.codiceRedazionale=15A03674&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
For new listings and sales price of the medicinal product HARVONI (ledipasvir/sofosbuvir)-authorized centrally by the European Commission with the European decision of 26/03/2014 and entered in the Community register of medicinal products with numbers: 1/14/EU/958/001 90 mg/400 mg film-coated tablets oral use-bottle (HDPE)-28 tablets EU/1/14/90/002 958 mg/400 mg film-coated tablets oral use-bottle (HDPE)-3 bottles 3X28 film-coated tablets Holder A.I.C.: GILEAD SCIENCES INTERNATIONAL LIMITED 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 No 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency; 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 Legislative Decree March 30, 2001, n. 165; Having regard to act July 15, 2002, # 145; 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 act December 24, 1993, no. 537 concerning "public finance corrective" with particular reference to art. 8; Visto l'art. 85, paragraph 20 of the law December 23, 2000, n. 388; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 on "rationalization measures of public finance", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Having regard to the December 14, 2000, law # 376 on "discipline of health sports and activities in the fight against doping"; Having regard to article 48, paragraph 33, November 24, 2003, law # 326, which has negotiating the price for products reimbursed by authorisation holders between agency and S. N.; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the Gazzetta Ufficiale della Repubblica Italiana n. 142 of June 21, 2006 on the introduction of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use and Directive 2003/94/EC; Having regard to the 1 February 2001 CIPE; Having regard to Council Regulation No 726/2004/EC; View the determination October 29, 2004 "Notes AIFA 2004 (Revision Notes CUF)", published in the ordinary supplement to the official journal # 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal, General series No 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal, General series No. 227, September 29, 2006 concerning "maneuver for Government subsidized and non-subsidized pharmaceutical expenditure"; Having regard to the application with which the firm GILEAD SCIENCES INTERNATIONAL LIMITED has applied for classification, for the purposes of new listings '; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting on 10/12/2014; Having regard to the opinion of the pricing and reimbursement in the seat of 26/01/2015; Having regard to resolution No. 5 dated February 18, 2015 AIFA's Board of Directors adopted on the proposal of the Director General; Whereas for the proper management of the various stages of deployment, the medicinal product should be assigned a national identification number;
Determines Art. 1 Description and assigning AIC To medicinal product HARVONI (ledipasvir/sofosbuvir) in the packages shown are awarded the following national identification numbers: 90 mg/400 mg film-coated tablets oral use-bottle (HDPE)-28 tablets AIC # 043731013/E (10) 19QL25 (based on 32) 90 mg/400 mg film-coated tablets oral use-bottle (HDPE)-3 bottles 3X28 film-coated tablets AIC # 043731025/E (based on 10) 19QL2K (based on 32) medical indications: Harvoni is indicated for the treatment of chronic hepatitis C (chronic hepatitis C, CHC) in adults.
For activities specific to the genotype of the hepatitis C virus (HCV), refer to the text of the summary of product characteristics.
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