Retrieved 11 January 14, 2015 V&A determines the variation # 4: C.I.) Permission.
With regard to medicine: AMINOVEN.
Procedure number: DE 160/01-02/H//II/097.
Authorized updating of the summary of product characteristics at sections: 4.2 (adding the dose in the pediatric population 2-18 years and the absence of clinical trials in the paediatric population) 4.6, 4.3, 4.4, 4.5, 4.8, 4.9, 5.2, and 5.3 and the corresponding paragraphs of the leaflet.
Concerning the medicine AMINOVEN, in the forms and packages listed below: 034562013-500 ml 1 vial 5%;
034562025-500 ml bottles 5% 10;
034562037-5% 6 bottles 1000 ml;
034562049-10% 1 500 ml bottle;
034562052-10% 10 500 ml bottles;
034562064-10% 6 1000 ml bottles;
034562114-5% 12 500 ml bags;
034562126-10% 12 500 ml bags;
034562138-10% 6 1000 ml bags.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Fresenius Kabi Italy S.r.l.
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 April 24, 2006. 219 and subsequent amendments and additions, 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.
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 subsequent amendments and supplements, 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, 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.