Modifica secondaria di un'autorizzazione all'immissione in  commercio
  di un medicinale per uso umano, apportata ai sensi del  regolamento
  1234/2008/CE del 24 novembre 2008 

  Titolare : KEDRION S.p.A. 55051 Castelvecchio Pascoli - LUCCA 
  Specialita' Medicinale : UMAN BIG 
  Confezioni: 023782016, 023782028 
  Codice pratica: C1A/2011/1347 
  N° procedura: IT/H/0166/001/IA/007 
  N° e tipologia variazione: B.I.b.1.d IA 
  Oggetto della modifica: Change in the specification  parameters  of
ethanol  for  fractionation,  material  used  in  the   manufacturing
process. The two obsolete parameters methanol and acetone  have  been
deleted. 
  From:  Manufacturing  formula:  95  percent  Ethanol  (95   percent
alcoholic solution constituted by 5 percent water and not  less  than
by 95 percent mixture of ethanol,  acetone  and  methanol  in  which:
acetone less than or equal to 2.1 percent v/v; methanol less than  or
equal to 3.2 percent v/v) 
  To: Manufacturing formula: Ethanol for  fractionation  (95  percent
alcoholic solution constituted by 5 percent water and not  less  than
by 95 percent of ethanol) and 96 percent Ethanol, in compliance  with
the monograph n°1317, Ph. Eur. current edition, that is required  for
the quantitative reintegration of the losses that  occur  during  the
distillation procedure of the mother waters. 
    
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Il procuratore 
                        dott.ssa Paola Berti 

 
T11ADD12629