Review Product Marketing Authorisation For Human Use "nebivolol Zentiva».

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

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Retrieved January 14, 2015 V&A # 30/2015 of Procedure determines EU n: UK/H/5639/001/II/012.
Type II variation: B.I.z.
Are authorized the following variation: ASMF update for the active ingredient ' nebivolol hydrochloride manufacturer-supplied ' ' Hetero Drugs Limited» (AP-03 January-2011 AP-00 version July-2013) and the specifications of the active substance applied by the manufacturer of the finished product ' Specifar SA ' (from version 0034-06 to version QC-ACM-QC-ACM-14455-00).
With respect to medicinal product: NEBIVOLOL ZENTIVA and authorised pack sizes the placing in Italy following the mutual recognition procedure.
A.I.C. holder: Zentiva Italy S.r.l.
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 Journal No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.