Reclassification Of The Medicinal Product For Human Use "product Efdege ', For The Meaning Of Article 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Resolution No. 480/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Efdege», ai sensidell'articolo 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 480/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-11&atto.codiceRedazionale=15A03434&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

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 "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.; Visto l'art. 5 222/2007 law published in the Official Journal No. 279 of November 30, 2007; Having regard to the Legislative Decree of April 8, 2003, n. 95, on the implementation of Directive 2000/38/EC and introducing a list of medicines to be subjected to intensive monitoring; 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"; Given the decree by which the company was entitled to IASON GMBH placing on the market of the medicinal PRODUCT EFDEGE (18F-fluoro-deoxyglucose); Having regard to the notification procedure FR/HR/0243/001/IB/007 transmitted by competent authority of the reference Member State (RMS); Having regard to the application with which the firm IASON GMBH has applied for reclassification of the Pack with AIC # 036751028; Having regard to the application with which the company IASON GMBH has applied for classification, for the purposes of new listings, new therapeutic indication for packaging with Ma n. 036751016 and 036751028; Viewed handouts annexes forming an integral part of this determination; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of November 10, 2014; Having regard to the opinion of the pricing and reimbursement at its meeting of November 26, 2014; Having regard to resolution No. 5 dated February 18, 2015 AIFA's Board of Directors adopted on the proposal of the Director General;
Causes: Art. 1

Classification for the purposes of new listings is the new therapeutic indication: Medicine for diagnostic use only. The use of fluodeossiglucosio (18F) is shown in Positron Emission Tomography (PET) in adults and children. Oncology In patients undergoing oncologic diagnostic procedures which identify functions or diagnostic target diseases in which it is represented by the increasing influx of glucose in specific organs or tissues. The following recommendations were sufficiently substantiated. Diagnosis of solitary pulmonary nodules-discovery characterization of tumors of unknown origin revealed for example cervical adenopathy, bone or liver metastasis-characterization of a pancreatic mass. Head and neck cancer staging-including assistance in guided biopsy-Lung Cancer locally advanced breast cancer-primitive-esophageal cancer-Pancreatic Cancer-Colorectal Cancer, particularly in relapsing cases-malignant Lymphoma-Malignant Melanoma, Breslow index > 1.5 mm or metastases at first diagnosis-therapeutic response monitoring malignant lymphoma-cancer of the head and neck in the event of Detection reasonably suspect of recurrences-Glioma with high degree of malice (III or IV)-malignant tumors of the head and the neck-thyroid cancer (Medullary): patients with increased levels of serum thyroglobulin and negative results to the global body scintigraphy with radioactive iodine-primitive lung cancer-breast cancer-Pancreatic Cancer-Colorectal Cancer-ovarian cancer-malignant Lymphoma-Malignant Melanoma Cardiology Cardiology diagnostic indication, the target is composed of the myocardium vital that absorbs glucose but is ipoperfuso, which must be considered before using the most appropriate imaging technique for blood flow. -Assessment of myocardial viability in patients with severe left ventricular function candidates for revascularization when conventional imaging techniques are not decisive. Neurology neurological diagnostic and target indication is the glucose interictal ipometabolismo. -Localization of epileptogenic foci in the Presurgical evaluation of epilepsy partial time. Infectious or inflammatory diseases infectious or inflammatory diseases, diagnostic and ' target tissue or structures with an abnormal content of activated leukocytes. In these conditions, the following indications are sufficiently documented: localization of abnormal foci which guide the etiological diagnosis in case of fever of unknown origin. Diagnosis of infection caused by:-chronic bone infection and/or suspected of adjacent structures: Osteitis, osteomyelitis, discitis or ankylosing, even where there are metal implants-diabetic patients with suspected osteomyelitis Charcot neuroarthropathy of the foot and/or soft tissue infection-pain in the presence of hip replacement surgery-vascular prosthesis-fever in patients suffering from AIDS-detection of metastatic septic foci in case of bacteremia or endocarditis. Detecting the extent of inflammation caused by:-Sarcoidosis-inflammatory bowel disease-Vasculitis affecting large vessels therapeutic follow-up alveolar echinococcosis inoperable for finding active localizations of the parasite during medical treatment and later its withdrawal, the medicine PRODUCT EFDEGE (18F-fluoro-deoxyglucose) is refunded as follows: "1GBQ/ml solution for injection" 1 multidose vial from 11 ml # AIC 131KP8 036751016 (10) (32) new listings ' class : H price ex factory (excluding VAT): € 2,800/0.6 to MBq Pack "1GBQ/ml solution for injection" 0.2 ml multidose vial containing 1 to 20 ml of solution # AIC 131KPN 036751028 (10) (32) new listings ' class: H price ex factory (excluding VAT): € 2,800/0.6 to MBq Discount price ex factory to public facilities as required by contractual conditions.