Review Of The Marketing Authorisation Of Talunimedicinali For Human Use.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio di talunimedicinali per uso umano.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-31&atto.codiceRedazionale=15A02275&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved March 4, 2015 to 393 V determines the authorization # & variation: C.I. z) several changes with respect to medicines INEGY, VYTORIN, ZEKLEN, GOLTOR, SINVACOR, ZOCOR, LIPONORM;
Number of steps: # DE/H/xxxx/WS/208 and authorized updating of the summary of product characteristics 4.4, 4.5 and 5.2, sections on medicinal products INEGY, VYTORIN, ZEKLEN, GOLTOR, SINVACOR, ZOCOR, LIPONORM shapes and packagings authorized;
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
MA holders: MSD Italy S.r.l., with registered office and tax domicile in Rome (RM), Via Vitorchiano 151, cap. 00189, Italy, tax code 00422760587;
Merck Sharp & Dohme Limited with registered office and address in HERTFORD ROAD-HODDESDON-HERTFORDSHIRE, EN11 9BU United Kingdom NEOPHARMED Gentili _ S.r.l., with registered office and tax domicile in Milano (MI), Via San Giuseppe Cottolengo, 15, CAP 20143, Italy, Codice Fiscale 06647900965 Addenda Pharma S.r.l., with registered office and tax domicile in Rome (RM), Viale Shakespeare, 47, 00144, Italy, social security CAP Printed 05643891004 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, the summary of product characteristics;
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.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.