Comunicazione notifica regolare V&A 
 

  Medicinale: ACIDO ACETILSALICILICO  E  VITAMINA  C  ANGENERICO  400
mg+240 mg compresse effervescenti 
  Codice farmaco: (AIC n. 034586...) 
  Codice Pratica N°.: N1B/2016/2306 
  Tipologia   variazione   oggetto   della    modifica:    Type    IB
unforseen-B.II.a.3.z. ; Type IA B.II.a.3.b.1);  Type  IB  by  default
B.II.b.3.a.) ; Type IB by default - B.II.b.3.a.). 
  Tipo di modifica: Grouping variation 
  Modifica apportata: Type IB unforseen-B.II.a.3.z.  Changes  in  the
composition (excipients) of the  finished  product-  Deletion  of  an
excipient;  Type  IA  B.II.a.3.b.1)  Changes   in   the   composition
(excipients) of the finished product - Other excipients -  Any  minor
adjustment of the quantitative composition of  the  finished  product
with respect to excipients; Type IB by default 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  in  the  manufacturing  process;  Type  IB   by   default   -
B.II.b.3.a.) Change in the  manufacturing  process  of  the  finished
product, including an intermediate used in  tne  manufacture  of  the
finished product - Minor change in the manufacturing process. 
  Medicinale: ACIDO ACETILSALICILICO  E  VITAMINA  C  ANGENERICO  400
mg+240 mg compresse effervescenti 
  Codice farmaco: (AIC n. 034586...) 
  Codice Pratica N°.: N1B/2016/2394 
  Tipologia variazione oggetto della modifica: 2 Type IB 
  Tipo di modifica: Grouping variation Type IB B.II.d.1.g.) e Type IB
B.II.d.2.d.) 
  Modifica apportata: Type IB B.II.d.1.g. Change in the specification
parameters and/or limits of the finished product - Replacement  of  a
specification parameter with  its  corresponding  test  method  as  a
result of a safety or quality issue; type IB B.II.d.2.d.)  Change  in
test procedure for the finished product - Other  changes  to  a  test
procedure (including replacement). 
  Medicinale: PRAVASTATINA ANGENERICO 10 mg/20mg/40mg compresse 
  Tipologia      variazione       oggetto       della       modifica:
DE/H/2012/001-002-003-004/IA/016 
  Tipo di modifica: type IAIN, n. B.II.b.2.c.1.); 
  Modifica apportata: Change to importer, batch release  arrangements
and quality control testing of the finished product.  Replacement  or
addition of a manufacturer responsible for importation  and/or  batch
release.  Not  including  batch  control  /testing  (type  IAIN,   n.
B.II.b.2.c.1.). Addition of LEK Pharmaceuticals d.d.  Verovskova  57,
SI-1526 Ljubljana, Slovenia as batch releaser. 
  Decorrenza della modifica: dal giorno successivo  alla  data  della
sua pubblicazione in G.U. 

                       Il procuratore speciale 
                     dott.ssa Mariangela Caretto 

 
TX16ADD11156