Retrieved February 16, 2015 V&A # 267 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, preclinical, clinical or pharmacovigilance medicine SEVERAL BOUTS.
Authorized updating of the summary of product characteristics and package leaflet section corresponding to paragraph 4.8, relative to medicine «», in the forms and packs several bouts listed below: A.I.C. # 023185059-750 mg/15 ml syrup with adults ' sugar 1 bottle 200 ml ";
A.I.C. # 023185061-' 100 mg/5 ml syrup children with sugar 200 ml bottle ';
A.I.C. # 023185073-«adults 1.5 g granules for oral suspension» 20 sachets;
A.I.C. n. adult 750 mg/15 ml 023185097-«sugar-free syrup» 200 ml bottle;
A.I.C. n. 100 mg/5 ml 023185109-«children sugar-free syrup 125 ml bottle ';
A.I.C. # 023185123-1.5 g 20 effervescent tablets» «adult tablets.
It also authorized the rectification of the standard terms of the description of the packages mentioned above.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Sanofi S.p.a. (tax code no. 00832400154), registered office and tax domicile in viale Luigi Bodio # 37/B-20158 Milan (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 subsequent modifications and integrations, 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.
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, from period of thirty days from the date of publication in the Official Gazette of the Italian Republic of this determination. The A.I.C. holder makes it 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.