Retrieved April 14, 2015 V&A # 724 of authorization determines variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on clinical or non-clinical, quality, pharmacovigilance, relatively to the medicine PROVIGIL.
Numbers of procedure: DE/H/3259/001/II/007;
DE/H/3259/001/II/008.
Authorized updating of the summary of product characteristics, package leaflet and labelling, relatively to the medicine PROVIGIL, shapes and packagings listed below: 034369013-«100 mg tablets» 30 tablets in Opaque PVC/PVDC/aluminium.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Teva Italy S.r.l., with registered office and tax domicile in Milano (MI), Via Messina # 38, 20154, Italy, social security cap # 11654150157.
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.
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.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.