Review Product Marketing Authorisation For Human Use "imipenem And Cilastatin Kabi».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Imipenem Cilastatina Kabi».

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Retrieved December 16, 2014 V&A/2629 of Authorization determines the variation: B.I. to z) for the medicine: IMIPENEM and CILASTATIN KABI European procedure: UK/H/1334/002/II/013 Mah: FRESENIUS KABI ITALIA S.R.L., is hereby amended as follows: update of the DMF (ACS Dobfar) from version 1 "[1.9.2009] and 2 [01/2011]" to "[06/2013]" 3 version for the active ingredient Cilastatin sodium sterile with regard to marketing authorisations authorised pack sizes in Italy following of 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 AIFA 14/04/2014 # 371 of Determines published in the Official Gazette 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.