Modifica secondaria di un'autorizzazione all'immissione in  commercio
di specialita' medicinale per uso umano. Modifica apportata ai  sensi
          del decreto legislativo 29 dicembre 2007, n. 274. 
 

  Titolare: IBA MOLECULAR ITALY srl, Corso Italia, 13 - 20122 Milano 
  Specialita' medicinale: FLUODEOSSIGLUCOSIO [18 F] IBA 
  Confezioni    e    numero    A.I.C.:    185    MBq/ml     soluzione
iniettabile,flaconcino multidose da 15 ml - AIC 036946010/M- 
  Procedura    di    Mutuo    Riconoscimento    FR/H/229/01/IB/024/G,
raggruppamento di variazioni Tipo IA n° B.III.2.a.2) change to comply
with the  "Tetra-O-acetyl-mannose  triflate  for  radiopharmaceutical
preparations"  monograph  2294  of  the  Ph.Eur.,  current   edition,
concerning              the              drug               substance
1,3,4,6-Tetra-O-acetyl-2-O-trifluoromethanesulfonyl-beta-d-mannopyran
ose, codice pratica C1A/2011/22, approvata il 16/2/12. 
  Procedura    di    Mutuo    Riconoscimento     FR/H/229/01/IB/025G,
raggruppamento di variazioni tipo IB per l'aggiunta del  sito  CISbio
International  locato  a  Pessac  (Francia):B.I.a.1)  Change  in  the
manufacturer of a starting material/reagent/intermediate used in  the
manufacturing process of  the  active  substance  or  change  in  the
manufacturer (including where relevant quality control sites) of  the
active  substance,  where  no   CEP   is   part   of   the   approved
dossier;B.II.b.1) Replacement or addition of a manufacturing site for
part  or  all  of  the  manufacturing   process   of   the   finished
product;B.II.b.1) Replacement or addition of a manufacturing site for
part  or  all  of  the  manufacturing   process   of   the   finished
product;B.II.b.2) Change to batch release  arrangements  and  quality
control   testing   of   the   finished   product,   codice   pratica
C1B/2011/27,approvata l'8/3/12. 
  Procedura    di    Mutuo     Riconoscimento     FR/H/229/01/IB/28G,
raggruppamento di variazioni di  tipo  IB  per  l'aggiunta  del  sito
CISbio   International   locato   a   Sarcelles   (Francia):B.II.b.1)
Replacement or addition of a manufacturing site for part  or  all  of
the manufacturing process of the finished product;B.I.a.1) Change  in
the manufacturer of a starting material/reagent/intermediate used  in
the manufacturing process of the active substance or  change  in  the
manufacturer (including where relevant quality control sites) of  the
active  substance,  where  no   CEP   is   part   of   the   approved
dossier;B.II.b.1) Replacement or addition of a manufacturing site for
part  or  all  of  the  manufacturing   process   of   the   finished
product;B.II.b.2) Change to batch release  arrangements  and  quality
control   testing   of   the   finished   product,   codice   pratica
C1B/2011/1388,approvata l'8/3/12 
  Procedura di Mutuo Riconoscimento FR/H/229/01/IA/029, variazione IB
per armonizzazione  specifiche  acqua  arricchita  (H218O):n.B.I.b.1)
Change in the specification parameters and/or  limits  of  an  active
substance, starting material /intermediate  /  reagent  used  in  the
manufacturing  process  of  the  active  substance,  codice   pratica
C1A/2011/1191,approvata il 21/02/12 
  I lotti gia' prodotti possono essere mantenuti in commercio fino 
  alla data di scadenza indicata in etichetta. 
  Decorrenza della modifica:  dal  giorno  successivo  alla  data  di
pubblicazione nella Gazzetta Ufficiale. 

                        Legale rappresentante 
                          Enrico Seccamani 

 
T12ADD4354