Retrieved February 25, 2015 V&A # 373/2015 of authorization determines variation with respect to the medicine AMLODIPINE DOC GENERICI.
Are authorized the following variation: Expanding limits on specific related shelf life «Impurity RC3», for the tablets of AMLODIPINE BESYLATE: from 0.3% to 0.5% in relation to the NMT NMT medicinal product and authorisation authorised pack sizes in Italy as a result of decentralized procedure.
How to: NL/H/0946/001-002/II/025.
Types of variation: b. II. d. 1. and holder A.I.C.: Doc Generici 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 paragraph 5 of the 14/04/2014 # 371 Determines AIFA published in the Official Journal 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.