Modifica secondaria di un'autorizzazione all'immissione in  commercio
di specialita' medicinali per uso umano. Modifica apportata ai  sensi
del DL.vo  29/12/2007,  n.  274.  Modifica  apportata  ai  sensi  del
                    Regolamento (CE) n. 1234/2008 
 

  Titolare AIC: Valeas spa - Via Vallisneri, 10 - 20133 Milano 
  Specialita' medicinale: FEVRALT - AIC N. 038712016/M 
  Dosaggio, forma farmaceutica e confezioni: 100 mg/5 ml  sospensione
orale per bambini - flacone 100 ml 
  Codice pratica: C1B/2012/1928 - IT/H/142/001/IB/004/G 
  Grouping variations (IA/IAin/IB) 
  IB - B.II.b.1 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
non-sterile medicinal products (Temmler Italia srl) 
  IAin - B.II.b.1 Replacement or addition of a manufacturing site for
part or all of the manufacturing process  of  the  finished  product:
Primary packaging site. b) Primary  packaging  site  (Temmler  Italia
srl) 
  IAin - B.II.b.1 Replacement or addition of a manufacturing site for
part or all of the manufacturing process  of  the  finished  product:
Secondary packaging site. a) Secondary packaging site (Temmler Italia
srl) 
  IAin - B.II.b.2 Change to batch release  arrangements  and  quality
control testing of the finished product. b) Replacement  or  addition
of a manufacturer responsible for batch release  2.  Including  batch
control/testing (Temmler Italia srl) 
  IA - B.II.b.2 Change to  batch  release  arrangements  and  quality
control testing of the finished product. a) Replacement  or  addition
of a site where batch control/testing take place (Eurofins BIOLAB) 
  IB -  B.II.e.1  Change  in  immediate  packaging  of  the  finished
product. a) Qualitative and quantitative composition - 2.  Semi-solid
and non-sterile liquid pharmaceutical forms 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                      Il legale rappresentante 
                     dott.. Virgilio Bernareggi 

 
T12ADD17751