Retrieved February 23, 2015 V&A # 338/2015 of Procedure determines EU n.: NL/H/1250/001/II/019.
Type II variation: b. II. e. 1. a. 3).
Are authorized the following variation: review of the immediate packaging of the finished product by the addition of a rubber stopper Omniflex 3 g.
With respect to medicinal product: EPIRUBICIN TEVA and authorised pack sizes the placing in Italy following the mutual recognition procedure.
A.I.C. holder: Teva 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.