Regime Of New Listings And Price Of The Medicinal Product For Human Use "fycompa (Perampanel)», Authorized With Centralizzataeuropea Procedure By The European Commission. (Resolution No. 184/2015).

Original Language Title: Regime di rimborsabilita' e prezzo del medicinale per uso umano«Fycompa (perampanel)», autorizzata con procedura centralizzataeuropea dalla Commissione europea. (Determina n. 184/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-16&atto.codiceRedazionale=15A01860&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

For new listings and sales price of the medicinal product FYCOMPA (perampanel)-authorized centrally by the European Commission with the European decision of 23/07/2012 and entered in the Community register of medicinal products with numbers: 1/12/001/776/EU 2 mg-film-coated tablet-oral-blister (PVC/aluminium)-7 tablets; EU/1/12/776/002 4 mg-film-coated tablet-oral-blister (PVC/aluminium)-7 tablets; EU/1/12/776/003 4 mg-film-coated tablet-oral-blister (PVC/aluminium)-28 tablets; EU/1/12/776/004 4 mg-film-coated tablet-oral-blister (PVC/aluminium)-84 tablets; EU/1/12/776/005 6 mg-film-coated tablet-oral-blister (PVC/aluminium)-7 tablets; EU/1/12/776/006 6 mg-film-coated tablet-oral-blister (PVC/aluminium)-28 tablets;
EU/1/12/776/6 mg-007-film-coated tablet oral use-blister (PVC/aluminium)-84 tablets;
EU/1/12/776/008 8 mg film coated tablet-oral-blister (PVC/aluminium)-7 tablets; EU/1/12/776/009 8 mg film coated tablet-oral-blister (PVC/aluminium)-28 tablets; EU/1/12/776/010 8 mg film coated tablet-oral-blister (PVC/aluminium)-84 tablets; EU/1/12/776/011-coated-tablet 10 mg-oral-blister (PVC/aluminium)-7 tablets; EU/1/12/776/012 10 mg film coated tablet-oral-blister (PVC/aluminium)-28 tablets; EU/1/12/776/013 10 mg film coated tablet-oral-blister (PVC/aluminium)-84 tablets; EU/1/12 12/014/776 mg film coated tablet-oral-blister (PVC/aluminium)-7 tablets; EU/1/12/12/015 776 mg film coated tablet-oral-blister (PVC/aluminium)-28 tablets;
EU/1/12 12/016/776 mg film coated tablet-oral-blister (PVC/aluminium)-84 tablets.
A.I.C. Holder: EISAI Europe 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 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 «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; Having regard to act December 24, 1993, no. 537 concerning "public finance" corrective action 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 laying «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 laying "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 the national health service between agency and marketing authorisation holders; 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 "notes October 29, 2004 determination 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 to the Government subsidized and non-subsidized pharmaceutical shopping»; Having regard to the application with which the firm EISAI Europe 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 of December 10, 2014; Having regard to the opinion of the pricing and reimbursement at its meeting of November 30, 2014; Having regard to resolution No. 1 of January 30, 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;
Causes: Art. 1 Description and assigning A.I.C. The medicinal product FYCOMPA (perampanel) in the packages shown are awarded the following national identification numbers: packaging:

2 mg-film-coated tablet-oral-blister (PVC/aluminium)-7 tablets-A.I.C. # 042581013/E (10) 18MH0P (based on 32); 4 mg-film-coated tablet-oral-blister (PVC/aluminium)-7 tablets-A.I.C. # 042581025/E (10) 18MH11 (based on 32); 4 mg-film-coated tablet-oral-blister (PVC/aluminium)-28 tablets-A.I.C. # 042581037/E (10) 18MH1F (based on 32); 4 mg-film-coated tablet-oral-blister (PVC/aluminium)-84 tablets-A.I.C. # 042581049/E (10) 18MH1T (based on 32); 6 mg-film-coated tablet-oral-blister (PVC/aluminium)-7 tablets-A.I.C. # 042581052/E (10) 18MH1W (based on 32); 6 mg-film-coated tablet-oral-blister (PVC/aluminium)-28 tablets-A.I.C. # 042581064/E (10) 18MH28 (based on 32); 6 mg-film-coated tablet-oral-blister (PVC/aluminium)-84 tablets-A.I.C. # 042581076/E (10) 18MH2N (based on 32); 8 mg film coated tablet-oral-blister (PVC/aluminium)-7 tablets-A.I.C. # 042581088/E (10) 18MH30 (based on 32); 8 mg film coated tablet-oral-blister (PVC/aluminium)-28 tablets-A.I.C. # 042581090/E (10) 18MH32 (based on 32); 8 mg film coated tablet-oral-blister (PVC/aluminium)-84 tablets-A.I.C. # 042581102/E (10) 18MH3G (based on 32); 10 mg film coated tablet-oral-blister (PVC/aluminium)-7 tablets-A.I.C. # 042581114/E (10) 18MH3U (based on 32); 10 mg film coated tablet-oral-blister (PVC/aluminium)-28 tablets-A.I.C. # 042581126/E (10) 18MH46 (based on 32); 10 mg film coated tablet-oral-blister (PVC/aluminium)-84 tablets-A.I.C. # 042581138/E (10) 18MH4L (based on 32); 12 mg film coated tablet-oral-blister (PVC/aluminium)-7 tablets-A.I.C. # 042581140/E (10) 18MH4N (based on 32); 12 mg film coated tablet-oral-blister (PVC/aluminium)-28 tablets-A.I.C. # 042581153/E (10) 18MH51 (based on 32); 12 mg film coated tablet-oral-blister (PVC/aluminium)-84 tablets-A.I.C. # 042581165/E (10) 18MH5F (based on 32). Medical indications: FYCOMPA is indicated for the adjunctive treatment of partial seizures with or without secondary generalization in patients with epilepsy by age 12 years or more.