Authorisation For The Medicinal Product For Usoumano «Rozex».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Rozex».

Read the untranslated law here:

Retrieved January 14, 2015 V&A # 40/2015 determines the Description and attribution MA is authorized the placing on the market of the medicinal product: "ROZEX" in form and packaging: 0.75% emulsion "cutaneous" 1 tube of 30 g; in place of the Pack already authorized "0.75% emulsion cutaneous" 1 50 g hose; under the conditions and with the specifications below.
MAh: Galderma Italy S.p.a. with registered office and tax domicile in via dell'annunciata, 21, 20121-Milano-fiscal code 01539990349.
In place of: packaging: "skin" emulsion 1% 0.75 50 g hose-AIC # 028809059 (10) 0VH5V3 (based on 32) is now entitled the packaging: packaging: "0.75% skin emulsion 30 g tube-AIC 1" # 028809073 (10) 0VH5VK (based on 32) dosage form: cutaneous emulsion.
Ingredients: 100 g of cutaneous emulsion contain: active substance: metronidazole 0.75 g.
Classification for the purposes of new listings package: AIC # 028809073-"0.75% emulsion cutaneous" 1 tube of 30 g.
New listings ' class "C".
Classification for the purposes of delivery set: AIC # 028809073-"0.75% emulsion cutaneous" 1 tube of 30 g-SOP: medicinal product not subject to medical prescription but not over the counter.
Packaging of printed material should be placed on the market with handouts as well as previously approved by this administration, with the only changes necessary to adapt the determination referred to in this excerpt.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Disposal packaging products already lots stocks identified by code: MA 028809059, can be kept on the market until expiry date stated on the label.
Date of determination from the day following that of its publication in the official journal of the Italian Republic.