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.   PT/H/1189/001-002/IA/031/G   -   Conclusa   il
11/12/2014 
  Modifica  apportata  ai  sensi  del  Regolamento  (CE)   1234/2008:
Grouping of variations costituito da: 
  Variation Type IA n. A.5.b): Change in the name and/or address of a
manufacturer/importer  of  the  finished  product  (including   batch
release or quality control testing sites). The activities  for  which
the  manufacturer/importer  is  responsible  do  not  include   batch
release. Change in name of manufacturer GenProbe to Hologic Ltd 
  Variation Type IAIN n. A.5.a): Change in the name and/or address of
a manufacturer/importer of  the  finished  product  (including  batch
release or quality control testing sites). The activities  for  which
the  manufacturer/importer  is  responsible  include  batch  release.
Update of the address of Owen Mumford from the  currently  registered
headquarters address to the OX7 5XP address where  the  functions  of
assembly  in   auto-injectors,   packaging,   quality   control   for
performance  tests  on  finished  product  and  batch   release   are
performed. 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Un procuratore 
                     dott. Maurizio De Clementi 

 
T14ADD14704