Modifica secondaria di autorizzazione all'immissione in commercio  di
medicinali per uso umano. Modifica apportata ai sensi  del  D.Lgs  29
                       dicembre 2007, n. 274. 
 

  Titolare: Actavis  Group  PTC  ehf  -  Reykjavikurvegi  76-78,  220
Hafnarfjörður (Islanda) 
  Medicinale: DOXORUBICINA ACTAVIS PTC 
  Confezioni e numeri A.I.C.: tutte (AIC n.040693) 
  Codice Pratica: C1B/2013/2559 - Procedura n. NL/H/2251/001/IB/003G 
  Raggruppamento di  variazioni  -  IB  BIIb1f:  Actavis  Italy  SpA,
Nerviano (MI) as Finished  Product  manufacturer  (including  primary
packaging site) - IA BIIb2a: Actavis  Italy  SpA,  Nerviano  (MI)  as
batch control/testing site  -  IB  BIIb3z:  Change  in  manufacturing
process of finished product - IB BIIb4a: Change  in  batch  sizes  of
finished product - IB BIIe4c: Change in vial dimensions for  10mg/5ml
(10ml) and 20mg/10ml (15ml) -  IB.BIIcz:  Deletion  of  reference  of
excipients suppliers - IA BIIb5c:  Change  IP  tests  applied  during
manufacture of Finished product (deletion of filter  integrity  after
filtration with ethanol) - IA BIIb5c:  Change  to  IP  tests  applied
during manufacture of Finished product (deletion of Identification by
HPLC and  UV)  -  IA  BIIb5c:  Change  to  IP  tests  applied  during
manufacture of Finished product (deletion of Assay of  doxorubicin  -
HPLC) - IA.BIIb5a: Tightening of IP limits. 
  Codice Pratica: C1B/2013/2752 - Procedura n. NL/H/2251/001/IA/005 
  Variazione tipo IA BIII1a2: Updated CEP from  an  already  approved
manufacturer  (Synbias  Pharma  Ltd,   Ukraine   -   Certificate   of
Suitability No. R1-CEP 2004-059-Rev01). 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta. 

                           Un procuratore 
                            Lorena Verza 

 
T14ADD302