Retrieved determines V December 2, 2014 2014 # 2546/& as the Authorization of the change relatively to the medicine PRONTOBARIO COLON.
Are authorized the following variation: b. II. 5-dose product concentration Change for parenteral, total utilization, when the amount of active substance per unit dose (i.e. dosage) remains the same, relative to medicine Prontobario Colon, shapes and wrappings, A.I.C. numbers: A.I.C. # 028557015-"94.015 g powder for rectal suspension" bag 400 g: == === === === === === === === === === === === === === === === | Da | A |
+=============================+===============+
| Chemistry documentation | |
| authorised | 3.2. P. 1 |
+-----------------------------+---------------+
| | Barium Sulphate |
| Barium Sulfate 94.015 (% w/w) | 96.48 (% w/w) |
+------------------------------+----------------+ is authorized the rectification of the standard terms and description of the Pack 94.015 g # 028557015 from: "A.I.C. powder for suspension 400 g bag" to "rectal 96.48% w/w powder for suspension" sacca rectal 400 g.
A.I.C. holder: Bracco Imaging Italy s.r.l. with registered office and tax domicile in via Egidio Folli # 50-20134 Milano (MI)-Italy; (tax ID # 05501420961).
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 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.