Review Product Marketing Authorisation For Human Use «Sinifev».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Sinifev».

Read the untranslated law here:

Retrieved January 26, 2015 V&A # 97 determines the permission of variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, pharmacovigilance, clinical or preclinical, relative to medicine SINIFEV;
Authorized updating of the summary of product characteristics, package leaflet, relative to medicine SINIFEV, in the forms and packages listed below: AIC # 036061012-"20 mg/ml oral suspension 100 ml bottle" AIC # 036061024-"20 mg/ml oral suspension 150 ml bottle" AIC # 036061036-"20 mg/ml oral suspension" bottle 200 ml handouts corrected and approved shall be annexed to the assessment under this extract.
MAh: ABBOTT S.R.L. (tax number 00076670595) with registered office and tax domicile in S.R. 148 Pontina KM 52 SNC-Aprilia 04011, Campoverde-Latina (LT) 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 article 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.