Modifica secondaria di autorizzazione all'immissione in commercio  di
specialita' medicinale per uso umano. Modifica apportata ai sensi del
                           D.Lgs 274/2007 
 

  Titolare A.I.C.: B. Braun Melsungen AG, Melsungen (Germania) 
  Codice      pratica:       C1A/2014/1839.       Procedura       n.:
UK/H/3634/001/IA/005/G. 
  Specialita' medicinale: GELASPAN 4%. 
  Confezione e n. di A.I.C.: tutte le confezioni e relativi numeri di
A.I.C. 
  Modifica apportata ai sensi del regolamento CE 1234/2008. 
  Tipo di  modifica:  A.4  Change  in  the  name  of  a  manufacturer
(including where relevant  quality  control  testing  sites)  of  the
active substance, (where specified in the technical dossier) where no
Ph. Eur. Certificate of Suitability is part of the approved dossier. 
  Sodium Acetate 3H2O: da: Kemira ChemSolutions B.V. a: Niacet B.V.. 
  B.III.1.b.4 Deletion of Ph. Eur. certificate of suitability for  an
active substance used in the  manufacturing  process  of  the  active
substance. (R1-CEP 2004-143-rev02). 
  B.II.e.5 Change in pack size of the finished product.  Eliminazione
della confezione "Plastic bags "Ecobag" (non-PVC) 1000 ml/ 10 x  1000
ml" 
  B.II.e.7 Change in supplier of packaging components b)  Replacement
of a supplier. 
  Polyethylene  Granulate:  da:  Basell  NV,  Netherlands  a:  Basell
Polyolefine GmbH, Germany; da Arkema (former Atofina), France a INEOS
Bamble AS, Norway. 
  B.III.1.a.2  Submission  of  an   updated   Eur.   certificate   of
suitability  for  an  active  substance  from  an  already   approved
manufacturer. 
  Calcium  Chloride  2H2O:  da   R0-CEP   2006-263-Rev02   a   R1-CEP
2006-263-Rev00; 
  Magnesium  Chloride  6H2O:  da  R0-CEP  2006-264-Rev01   a   R1-CEP
2006-264-Rev00. 
  B.III.1.b.3  Submission  of  an   updated   Eur.   certificate   of
suitability for a starting material used in the manufacturing process
of the active substance from an already approved manufacturer. 
  Da Rousselot SAS, France a Rousselot, Netherlands. 
  B.III.1.a.1 Submission of a new Eur. certificate of suitability for
an active substance from an already approved manufacturer. 
  Potassium Chloride: R0-CEP 2010-380-Rev01. 
  B.I.b.2.a Change in test procedure for a starting material  in  the
manufacturing process of the active substance. 
  Decorrenza della modifica: dal giorno successivo  alla  data  della
sua pubblicazione in Gazzetta Ufficiale. 

                      L'amministratore delegato 
                         dott. Luigi Boggio 

 
T14ADD9416