Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01382&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 16, 2015 V&A # 264 of authorization determines variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, pharmacovigilance, clinical or preclinical, relative to medicine CARDIRENE.
Authorized updating of the summary of product characteristics, package leaflet, relative to medicine «Cardirene», in the forms and packages listed below: A.I.C. # 028717015-' 160 mg powder for oral solution» 30 sachets;
A.I.C. # 028717027-' 300 mg powder for oral solution» 30 sachets;
A.I.C. # 028717039-«100 mg powder for oral solution» 30 sachets;
A.I.C. # 028717041-' 75 mg powder for oral solution» 30 sachets.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
MAh: Sanofi S.P.A. (tax number 00832400154) with registered office and tax domicile in Viale Luigi Bodio, 37/B-20158 Milano (MI) Italy.
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
2. In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree No 219 April 24, 2006 and s, 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.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in art. 2, paragraph 1, of the present, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users, as from the end of 30 days from the date of publication in the Official Gazette of the Italian Republic of this determination. The Mah makes accessible to pharmacist leaflet updated within the same timeframe.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.
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