Review Of The Regime Of Prescription Of Medicinal Product For Human Use "simponi". (Determines # 361/2015).

Original Language Title: Modifica del regime di prescrizione del medicinale per uso umano«Simponi». (Determina n. 361/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-16&atto.codiceRedazionale=15A02773&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR GENERAL Saw art. September 30, 2003 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency, and as amended and supplemented; 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 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; View the determination August 4, 2010, n. 427, published in the official journal of August 30, 2010, General series No. 202, ordinary Supplement No. 210, with which the company Janssen Biologics B.V. obtained the authorisation for the medicinal product Simponi; Having regard to the opinion of the technical-Scientific Committee at its meeting on 19-21 January 2015, who felt that the specific indication psoriatic arthritis should be excluded from prescription with registry, arranging the removal of the same for the active ingredient golimumab;
Causes: Art. 1 prescription regime Change for prescription of medicinal product Simponi, on the indication psoriatic arthritis (AP), and ' removed references to monitoring log under art. 3 determining August 4, 2010, # 427, published in Official Gazette of August 30, 2010, General series # 202, ordinary Supplement No. 210. Negotiating conditions remain unchanged.