MODIFICA SECONDARIA DI UN'AUTORIZZAZIONE ALL'IMMISSIONE IN  COMMERCIO
  DI SPECIALITA' MEDICINALE PER  USO  UMANO.  Modifica  apportata  ai
  sensi D.Lgs. 274/07. 

  TITOLARE: IPSEN S.p.A. sede legale e domicilio fiscale  in  Via  A.
Figino 16, 20156 Milano 
  SPECIALITA' MEDICINALE: IPSTYL 
  CONFEZIONE E NUMERO DI A.I.C.: 1 flaconcino polvere 30 mg + 1 fiala
solv. 2 ml + 2 aghi + 1 siringa - A.I.C. n. 029399019 
  MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1234/2008: 
  Codice pratica: N1A/2011/97. 
  Tipo B.II.d.1: aggiunta di un nuovo parametro di specifica. 
  DA: 3.2.P.5.1 Specifications (Powder) 
  Release specifications 
  General characteristics of the lyophilisate vial: 
  Slightly tinted transparent glass vial  fitted  with  an  elastomer
stopper and crimped. Content is a  practically  white,  friable  cake
dispersible in water. 
  Shelf-life Specifications 
  General characteristics of the lyophilisate vial: 
  Practically white cake producing with the  suspension  vehicle,  an
easily injectable suspension using the syringe and needle supplied. 
  Not determined. 
  A: 3.2.P.5.1 Specifications (Powder) 
  Release and shelf-life specifications 
  General characteristics of the lyophilisate vial: 
  Slightly tinted transparent glass vial  fitted  with  an  elastomer
stopper and crimped. Content is  a  practically  white  friable  cake
dispersible in appropriate provided solvent. 
  General characteristics  of  the  reconstituted  suspension:  Milky
suspension 
  Injectability of reconstituted suspension: 
  Suspension may be pumped in and out with the  syringe  without  any
unusual resistance of the plunger. 
  I lotti gia' prodotti alla data di implementazione  sono  mantenuti
in commercio fino alla data di scadenza indicata in etichetta. 

                           Un Procuratore: 
                          Michela Maraschi 

 
T11ADD3634