Authorisation For The Medicinal Product For Usoumano «Zolmitriptan Doc Generici».

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

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Retrieved February 11, 2015 # 127/2015 of Medicine determines: ZOLMITRIPTAN DOC GENERICI.
A.I.C. holder: DOC Generici S.r.l., via Turati n. 40-20121 Milan.
Package: «2.5 mg film-coated tablets» 18 tablets in AL/AL; A.I.C. # 039887094 (10), 16187Q (32).
Dosage form: tablets.
Composition: each film-coated tablet contains: active ingredient: 2.5 milligrams of zolmitriptan.
Classification for the purposes of new listings is the packs referred to in art. 1 are placed, by virtue of art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537, and subsequent amendments, called class C (nn) ".
Classification for the purpose of the classification for the supply of the medicinal product ' Zolmitriptan DOC Generici» is the following: medicinal product subject to medical prescription (RR).
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.
Date of determination: from the day following its publication in the official journal of the Italian Republic.