Retrieved determines the 2550/2014 December 2, 2014 n V & Authorization of changes C.I. 4) Changes concerning the safety, efficacy and pharmacovigilance medicines for human and veterinary use-one or more amendments to the summary of product characteristics, labelling and package leaflet after new data regarding quality, pharmacovigilance, preclinical, clinical, or relatively to the medicine ESTRADERM MX.
Authorized updating of the summary of product characteristics 4.4 4.5 4.3, 4.2, paragraphs 4.8 and corresponding sections, and leaflet concerning the medicine ESTRADERM MX, shapes and packagings A.I.C. # 031773017-' 25 mcg/day transdermal» 031773029-8 A.I.C. no band-AIDS, "50 mcg/day transdermal» 8 band-AIDS, A.I.C. # 031773031-8 «» 100 mcg/day transdermal patches.
Handouts corrected and approved are attached to this determination.
A.I.C. holder: Novartis Pharma S.p.A. with registered office and tax domicile in largo Umberto Boccioni, 1-21040 Origgio (Varese-Italy) (fiscal code 07195130153).
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 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.
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.