Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01330&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved January 14, 2015 V&A # 45/2015 determines the description of medicine and assigning AIC.
It is authorised for placing on the market of the medicinal product: «MAALOX», also in form and packaging: «400 mg + 400 mg chewable sugar aroma red fruit» 30 tablets; In addition to the packaging already authorized under the conditions and with the specifications mentioned below: Mah: Sanofi S.P.A. with registered office and tax domicile in Viale Luigi Bodio, 37/B, 20158-Milan-tax code 00832400154;
Package: «sugar-400 mg + 400 mg chewable tablets 30-AIC aroma red fruits» n. 020702294 (10) 0MRT2Q (based on 32).
Pharmaceutical form: chewable tablets.
Composition: a chewable tablet contains: active ingredient: magnesium hydroxide 400 mg; aluminium oxide hydrate 400 mg.
Classification for the purposes of new listings package: AIC # 020702294-«400 mg + 400 mg chewable sugar aroma red fruits» 30 tablets.
New listings class is: "C-bis '.
Classification for the purposes of delivery set: AIC # 020702294-«400 mg + 400 mg chewable sugar aroma red fruit» 30 tablets-OTC: medicinal product not subject to medical prescription over the counter.
Packaging of printed material should be placed on the market with handouts, as previously approved by this administration, with the only changes necessary to adapt to this determination.
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.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14 paragraph 2 of d.lgs. # 219/2006, in virtue of which are not included in the printed those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of generic medicine.
Effect and efficacy of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.
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