Modifica secondaria di un'autorizzazione all'immissione in  commercio
  di specialita' medicinale per  uso  umano.  Modifica  apportata  ai
  sensi D.Lgs. 274/07. 

  Titolare A.I.C.: B. Braun Melsungen AG, Melsungen (Germania) 
  Codice pratica: C1A/2011/1391. 
  Specialita' medicinale, confezione  e  n.  di  A.I.C.:  Sterofudin,
tutte le confezioni e relativi numeri di A.I.C. 
  Modifica apportata ai sensi del regolamento CE 1234/2008. 
  Procedura n.: NL/H/0545/001/IA/019/G Grouping of variations. 
    A.4: Change in  the  name  of  a  manufacturer  (including  where
relevant quality control sites) or supplier of the active  substance,
starting material, reagent or intermediate used in the manufacture of
the active substance (where specified in the product  dossier)  where
no Ph. Eur. Certificate  of  Suitability  is  part  of  the  approved
dossier. 
      da: Kyowa Hakko Kogyo Co. Ltd. - a: Kyowa Hakko Bio Co. Ltd. 
    A.7: Deletion of manufacturing sites  (including  for  an  active
substance,  intermediate  or  finished   product,   packaging   site,
manufacturer responsible for batch release, site where batch  control
takes place, or supplier of a starting material, reagent or excipient
(when mentioned in the dossier).: 
      Deletion    manufacturer    NaCl    Kali    und    Salz     AG,
Friedrich-Ebert-Strasse 260, 34121 Kassel, Germany; 
      Deletion manufacturer CaCl Merck KGaA, Frankfurter Strasse  256
- 64293 Darmstadt, Germany. 
      Deletion   manufacturer   MgCl   Chemische    Fabrik    Lehrte,
Köthenwaldstrasse 2-6, D-31275 Lehrte, Germany. 
    B.III.1.a:Submission of a new or updated Ph.Eur.  certificate  of
suitability: 
      for     an     active     substance,     for     a     starting
material/reagent/intermediate used in the  manufacturing  process  of
the active substance, for an excipient. 
  European Pharmacopoeial Certificate of Suitability to the  relevant
Ph. Eur. Monograph. 
  New certificate from an already approved manufacturer: 
    Manufacturer NaCl: CEP R0-CEP 2008-105-Rev 00,  Akzo  Nobel  Salt
A/S, Hadsundvej 17 - 9550 Mariager, Denmark; CEP  R0-CEP-2007-367-Rev
00, Esco-european salt company GmbH & Co. KG, Landschaftsstrasse 1  -
30159 Hannover, Germany. 
    Manufacturer CaCl: CEP R0-CEP  2006-263-Rev  01,  Macco  Organics
S.R.O, Zahradni 46 - 79201 Bruntal, Czech Republic. 
    Manufacturer MgCl: CEP R0-CEP  2006-264-Rev  01,  Macco  Organics
S.R.O, Zahradni 46 - 79201 Bruntal, Czech Republic. 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta ai sensi 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. 

                      L'amministratore delegato 
                         dott. Luigi Boggio 

 
T11ADD10078