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Review Of The Supply Of The Medicinal Product For Human Use "scheme Proviron». (Determines No 1560/2014).

Original Language Title: Modifica del regime di fornitura del medicinale per uso umano«Proviron». (Determina n. 1560/2014).

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The DIRECTOR GENERAL Saw 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 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 opinion of the Technical Committee at its meeting on 21-23 July 2014 scientific, relating to the modification of the provision for the medicinal product Proviron (mesterolone), from medicinal product subject to medical prescription (RR) a medicinal product subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialists (RNRL), with indication of the specialists : Endocrinologist and urologist, who are also assigned the responsibility to draw up a plan of treatment.
Causes: Art. 1 Review provision To medicinal product Proviron (mesterolone) applies the following provision: medicinal product subject to medical prescription, to be renewed from time to time, be sold to the public on prescription of hospitals or specialists: an endocrinologist and urologist (RNRL). Negotiating conditions remain unchanged.