Retrieved December 2, 2014 # the determination 2507/2014 V & procedure numbers: UK/H/0295/001/II/029, UK/H/0295/001/II/030 and 0295/UK/H/001/II/031.
Authorized updating of the summary of product characteristics in paragraph 4.4 and corresponding paragraphs leaflet to include information relevant to the risk of pseudomembranous colitis; the update of the summary of product characteristics in paragraphs 4.8 and 6.6 and corresponding paragraphs leaflet to include information about systemic allergic reactions; the update of the summary of product characteristics in paragraphs 4.6 and 5.3 and corresponding paragraphs leaflet to include non-clinical information.
It is entitled the adaptation to QRD template, form and packaging below: 1 2% cream # 028978031 A.I.C.-15 g tube.
Handouts corrected and approved are attached to this determination.
A.I.C. holder: Glaxosmithkline S.p.a.
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination to 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.
The holder of the patent protection A.I.C. the generic drug is exclusively responsible for the full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The holder of the A.I.C. generic drugs and is also responsible for full compliance with the provisions of art. 14, paragraph 2, of Legislative Decree No 219 April 24, 2006 and s, in virtue of which are not included in the printed those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of generic medicine.
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 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.