Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01387&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved February 16, 2015 V&A # 258 of authorization determines variations: type II variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, preclinical, and clinical or pharmacovigilance type IB variation: C.I. z) Other changes with respect to the drug OMNISCAN;
Authorized updating of the summary of product characteristics, package leaflet and labelling, relatively to the drug OMNISCAN, shapes and packages listed below: AIC # 028993018-"0.5 mmol/ml solution for intravenous injection 10 ml bottle" AIC # 028993020-"0.5 mmol/ml solution for intravenous injection" 15 ml bottle AIC # 028993032-"0.5 mmol/ml solution for intravenous injection 20 ml bottle" AIC # 028993044-"0.5 mmol/ml solution for intravenous injection 5 ml bottle"
AIC # 028993057-"0.5 mmol/ml solution for injection for intravenous use 50 ml vials 10" AIC # 028993069-"0.5 mmol/ml solution for intravenous injection syringe 10 ml 1" AIC # 028993071-"0.5 mmol/ml solution for intravenous injection syringe 1 ml 15" AIC # 028993083-"0.5 mmol/ml solution for intravenous injection 20 ml prefilled syringe 1" AIC # 028993095-"0.5 mmol/ml solution for injection for intravenous use" 10 syringes 10 ml
AIC # 028993107-"0.5 mmol/ml solution for injection for intravenous use" 10 syringes 15 ml AIC # 028993119-"0.5 mmol/ml solution for intravenous injection 20 ml syringes 10" AIC # 028993121-"0.5 mmol/ml solution for injection" 40 ml polypropylene bottle handouts corrected and approved shall be annexed to the assessment, referred to in this excerpt.
MAh: GE Healthcare S.R.L. (tax number 01778520302) with registered office and tax domicile in via Galeno, 36, 20126-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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