Modifica secondaria di un'autorizzazione all'immissione in  commercio
di specialita' medicinale per uso umano. Modifica apportata ai  sensi
                                 del 
 
 
            Decreto Legislativo 29 dicembre 2007, n. 274. 
 

  Specialita' medicinale CHENPEN. 
  Confezioni: "150 microgrammi/0.3 ml soluzione iniettabile"  e  "300
microgrammi/0.3 ml soluzione iniettabile". 
  Codici confezioni: 040864011, 040864047, 040864023, 040864035. 
  Procedura MRP n. UK/H/0516/001-002/IA/025G - Conclusa il 6/11/2013 
  Modifica  apportata  ai  sensi  del  Regolamento  (CE)   1234/2008:
Grouping of variations costituito da: 
  Variation   Type   IA   n.   C.I.9:   Changes   to   an    existing
pharmacovigilance system as described in the DDPS  including:  Change
in the QPPV (a), Change in the  contact  details  of  the  QPPV  (b),
Change of the back-up procedure of the QPPV (c), Changes in the major
contractual arrangements with other  persons  or  organisations  (e),
Deletion  of  topics  covered  by   written   procedures   describing
pharmacovigilance activities (f),  Change  of  the  site  undertaking
pharmacovigilance activities (g), Other changes to the DDPS that does
not impact on the operation of the Pharmacovigilance system (h) 
  Variation  Type  IA  n.  B.II.b.2.a):  Change  to   batch   release
arrangements and quality control testing of the  finished  product  -
Replacement of QC site Prova (R & D) Limited, Unit 1-4  Craven  Court
Stanhope Road, Camberely Surrey GU15 3BW (United  Kingdom)  with  Gen
Probe Life Sciences, Appleton Place,  Appleton  Parkway,  Livingston,
West Lotian, EH54 7EZ (United Kingdom) 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Un procuratore 
                     dott. Maurizio De Clementi 

 
T14ADD6092