Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-02&atto.codiceRedazionale=14A10006&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
For new listings and sales price of the medicinal product Vibativ (telavancin hydrochloride)-authorized centrally by the European Commission with the European decision of September 2, 2011 and included in the Community register of medicinal products with numbers: 1/11/705/EU/001 250 mg powder for concentrate for solution for infusion-intravenous-vial (glass) 30 ml-1 vial;
EU/1/11/705/002 750 mg powder for concentrate for solution for infusion-intravenous-vial (glass) 50 ml-1 vial.
A.I.C. Holder: Clinigen Healthcare 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 n. 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 the rules of organisation and operation 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. 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"; Visto l'art. 48, paragraph 33, November 24, 2003, law No. 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 of September 29, 2006 concerning "maneuver for Government subsidized and non-subsidized pharmaceutical expenditure"; Having regard to the application with which the firm 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 of October 21, 2014; Whereas for the proper management of the various stages of deployment, the medicinal product should be assigned a national identification number;
Causes: Art. 1 Description and assigning AIC To medicinal product VIBATIV (telavancin hydrochloride) in the packages shown are awarded the following national identification numbers: packaging: 250 mg powder for concentrate for solution for infusion-intravenous use-30 ml vial (glass)-1 vial-AIC # 043539016/E (10) 19JQL8 (based on 32);
750 mg powder for concentrate for solution for infusion-intravenous-vial (glass) 1 vial-50 ml-AIC # 043539028/E (10) 19JQLN (based on 32). Medical indications: Vibativ is indicated for the treatment of adult patients with nosocomial pneumonia (NP) including pneumonia associated with mechanical ventilation, where it is known or suspected the cause from Methicillin-resistant Staphylococcus aureus (MRSA). Vibativ should only be used in situations where it is known or suspected that there are no other viable alternatives. Consideration should be given to official guidelines on the appropriate use of antibacterial medicines.
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