Authorisation For The Medicinal Product For Usoumano «Diathynil»

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

Read the untranslated law here:

Retrieved January 14, 2015 V&A # 43/2015 determines the Description and attribution number A.I.C.
It is authorised for placing on the market of the medicinal product: DIATHYNIL, also in form and packaging: «5 mg tablets» 30 tablets in pvc/al; In addition to the packaging already authorized under the conditions and with the specifications below.
A.I.C. holder: Avantgarde S.p.a., with registered office and tax domicile in via Pontina, km 30.400, 00040-Pomezia (Rome)-tax code 03724830587.
Package: «5 mg tablets» 30 tablets in pvc/al-A.I.C. # 028702076 (10) 0VCXCW (based on 32).
Dosage form: tablets.
Composition: each tablet contains: active ingredient: D (+) 5 mg biotin.
Classification for the purposes of new listings ' box: A.I.C. # 028702076-' 5 mg tablets» 30 tablets in pvc/al. New listings ': class ' C '.
Classification for the purposes of delivery set: A.I.C. # 028702076-' 5 mg tablets» 30 tablets in pvc/al-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 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 Legislative Decree No 219 April 24, 2006 and subsequent amendments and supplements the leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. 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.
Effect and efficacy of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.