Review Product Marketing Authorisation For Human Use «Vinorelbine Actavis».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-23&atto.codiceRedazionale=15A02075&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 24, 2015 V&A # 359/2015 of authorization determines variation in relation to drug VINORELBINE ACTAVIS is authorized the following variation: update of the DMF of manufacturer of the active substance "Jiangsu Hansoh Pharmaceutical Co., Ltd." the AP version: 36030-040-114-ASMF/1103 and RP: 114/36030-040-ASMF-1103, concerning the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
Procedures: UK/H/1082/001/II/015 type of variation: b. 1. z Mah: ACTAVIS ITALY S.P.A.
Inventory disposal lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 subparagraph 5 of Determines AIFA n. 371 of 14/04/2014 published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.