Comunicazione di notifica regolare V&A 
 

  Codice pratica: N1B/2015/3310 
  Titolare dell' AIC: Agips Farmaceutici srl 
  Specialita' medicinale: OMISTAT (SIMVASTATINA) 
  Confezioni e numeri di AIC: 
  "20 mg  compresse  rivestite  con  film"  28  compresse  -  AIC  n.
037364027 
  "40 mg  compresse  rivestite  con  film"  28  compresse  -  AIC  n.
037364054 
  Tipo di modifica: 
  B.II.b.1.a - IAIN - Replacement or addition of a manufacturing site
for part or all of the manufacturing process of the finished  product
- Secondary packaging site 
  B.II.b.1.b - IAIN - Replacement or addition of a manufacturing site
for part or all of the manufacturing process of the finished  product
- Primary packaging site 
  B.II.b.1.e - IB - Replacement or addition of a  manufacturing  site
for part or all of the manufacturing process of the finished  product
- e) Site where any manufacturing  operation(s)  take  place,  except
batch-release, batch control, primary and  secondary  packaging,  for
nonsterile medicinal products 
  B.II.b.2.c.2 - IAIN - Replacement or  addition  of  a  manufacturer
responsible for importation and/or batch release  -  Including  batch
control/testing 
  Decorrenza della modifica: dal giorno successivo  alla  data  della
sua Pubblicazione in G.U. 

                       L' amministratore unico 
                       dott. Giuseppe Radaelli 

 
T15ADD13386