Modifica secondaria di un'autorizzazione all'immissione in  commercio
di  medicinale  per  uso  umano.  Modifica  apportata  ai  sensi  del
                      Regolamento 1234/2008/CE 
 

  Titolare AIC: B. Braun Avitum AG. 
  Medicinale DUOSOL Soluzione per emofiltrazione AIC 037073 tutte  le
confezioni 
  Codice   Pratica   C1B/2017/2965   -    Procedura    Europea    n.:
NL/H/0504/001-003/IB/023/G - Tipo di  modifica:  Type  IA-  B.II.a.3.
b)1.: Description and Composition of the Drug Product: Module 3.2.P.1
Description and Composition of the Drug Product is  updated  with  an
upper and lower amount of water for injections. In  addition,  module
3.2.P.1 is amended with the amount of ingredients  of  each  solution
expressed also as mmol/l and with  the  sentence  "The  drug  product
solutions, before and after mixing  have  the  following  appearance:
Clear and colourless solution, free from visible particles". Type  IB
- B.II.z): Process validation and/or evaluation: Module 3.2.P.3.5  is
updated with regard to the  process  validation  reports  for  Duosol
without Potassium, Duosol with 2 mmol/l Potassium and Duosol  with  4
mmol/l Potassium as requested during the Repeat Use  Procedure.  Type
IB - B.II.z):P.3/ P.8 Holding time of bulk solution: Module 3.2.P.3.3
is updated with regard to the holding times for all three  strengths:
Maximum holding times between the  subsequent  individual  production
steps.  Preparation  of  solution  until   end   of   filling/sterile
filtration: a) holding time of electrolyte solution in closed vessel:
96 h; b) holding  time  of  sodium  bicarbonate  solution  in  closed
vessel: 10 h. The validation documentation of the holding  times  has
been included in the module 3.2.P.3.5. 
  I lotti gia' prodotti alla data della pubblicazione in  GU  possono
essere mantenuti in commercio fino alla data di scadenza indicata  in
etichetta ai sensi dell'art. 14 D.L.vo  178/91  e  s.m.i.  Decorrenza
della  modifica:  dal  giorno  successivo   alla   data   della   sua
pubblicazione in G.U. 

                       Un procuratore speciale 
                      dott.ssa Giuliana Gavioli 

 
TX18ADD5463