Review Product Marketing Authorisation For Human Use «Amixal»

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

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Retrieved 2 January 14, 2015 V&A determines the variation # Permission: B.I. z).
With regard to medicine: AMIXAL.
European procedure: 001-0543/DE/H/003/II/011.
A.I.C. Holder: B. Braun Melsungen AG.
Is amended as follows: Updating of the Active Substance Master File for the active ingredient ' lysine acetate» vendor-supplied "Kyowa Hakko Bio co., Ltd.» (version 03 of November 30, 2010).
With regard to marketing authorisations authorised pack sizes in Italy following the mutual recognition procedure.
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 April 14, 2014 # 371 determines AIFA published in Official Gazette No 101 of May 3, 2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.