Modifiche secondarie di un'autorizzazione all'immissione in commercio
di una specialita' medicinale per uso umano. Modifiche  apportate  ai
sensi del D.Lgs. n.  219/2006  e  s.m.i.  e  del  Regolamento  CE  n.
                              1234/2008 

  Codice Pratica: N1B/2020/854 
  Numero di Procedura Europea: IE/H/xxxx/WS/126. 
  Specialita' medicinale: GASTROMIRO 61,2% Soluzione (AIC 026899) 
  Titolare: Bracco Imaging SpA, Via Egidio Folli 50, 20134 Milano 
  Tipologia variazione: Grouping 15 variazioni: 4 di Tipo 1 B e 11 di
tipo 1 A: 
  n. 2 Tipo 1 B B.II.a.3.z Changes in the composition (excipients) of
the finished product: 1) Replacement of citric acid monohydrate  with
citric acid anhydrous 
  2) Replacement of Water for injection with Purified Water 
  Tipo 1 B B.II.b.1.e Replacement or addition of a manufacturing site
for part or all of the manufacturing process of the finished product:
Manufacturing site: E-Z-EM 
  Tipo 1 B B.II.b.4.a Change in the batch size (including batch  size
ranges) of the finished product: Batch size E-Z-EM: 500 L 
  Tipo 1Ain B.II.b.1.a Replacement or  addition  of  a  manufacturing
site for part or all of the manufacturing  process  of  the  finished
product: Secondary packaging site: E-Z-EM 
  Tipo 1 Ain B.II.b.1.b Replacement or addition  of  a  manufacturing
site for part or all of the manufacturing  process  of  the  finished
product: Primary packaging site: E-Z-EM 
  Tipo 1 A B.II.b.2. a Change to importer, batch release arrangements
and quality control testing of the finished product: Quality  Control
testing: E-Z-EM 
  Tipo  1  Ain  B.II.b.2.c.1  Change  to  importer,   batch   release
arrangements and quality control testing  of  the  finished  product:
Batch release: Bracco Imaging spa 
  n. 2 Tipo IA B.II.b.3.a Change in the manufacturing process of  the
finished product, including an intermediate used in  the  manufacture
of the finished product - Minor change: 1) Nitrogen no longer used  -
E-Z-EM 
  2) Use of 3 µm instead of 0.2 µm filter - E-Z-EM 
  n. 2 Tipo IA  B.II.b.5.a  Change  to  in-process  tests  or  limits
applied during the manufacture of the finished product -Tightening of
in-process limits: 1) IPC pH limit:  4.0-4.5  to  4.00-4.25  range  -
E-Z-EM 
  2) IPC Fill Limits: 20.5-21.5 mL, 51.0-53.0 mL and 101.5-104.5 mL -
E-Z-EM 
  n. 3 Tipo IA B.II.d.2.a. Change in test procedure for the  finished
product - Minor changes to an approved  test  procedure:  1)  Solvent
used  for  Assay  of  "Sodium  saccharinate  dihydrate   and   Sodium
cyclamate" -E-Z-EM 
  2) Free Aromatic Amine test method with manual modality- E-ZEM 
  3) Biological controls test - E-Z-EM 
  I lotti gia'  prodotti  alla  data  di  pubblicazione  in  Gazzetta
Ufficiale sono mantenuti in commercio  fino  alla  data  di  scadenza
indicata in etichetta. 

                           Un procuratore 
                       dott. Andrew Betournay 

 
TX21ADD3954