Review Product Marketing Authorisation For Human Use «Octagam»

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-27&atto.codiceRedazionale=15A00403&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 16, 2014 V&A/2627 of authorization determines variation: 2 B 2 B 4 B. I. a. B. I.e. 2. c relative to medicine: OCTAGAM.
European procedure: UK/H/325/01/II/064/G.
Mah: Octapharma LTD.
Is amended as follows: from: manufacturing process of Fraction II: temperature limit before separation of the fraction II: ≤ -6° C temperature limit of centrifuge effluent during the separation of the fraction II: ≤ -5° C at: temperature limit before separation of the fraction II: between-8.5° C and-6.0° C centrifuge outflow temperature limit during the separation of the fraction II : between-8.5° C and-4.0° C sample application In Process Control 1a with a limit of 7.0-7.8 pH after resuspension of Fraction II and sedimentation from OPG sites: production process-D Springe and OSA Lingolsheim: Step 1: separation of II by centrifugation at OPG sites: production process-D Springe and OSA Lingolsheim: Step 1: separation of II by centrifugation or alternatively by filtration without "Filter aid" (the ancillary materials filter) Elimination of phase opzionaledi adsorption of PPSB by using DEAE Sephadex in production site of OPG-D Springe.
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 subparagraph 5 of April 14, 2014 # 371 of AIFA Determines 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.