Modifica secondaria di autorizzazione all'immissione in commercio  di
medicinale per uso umano.  Modifica  apportata  ai  sensi  del  D.Lgs
                          219/2006 e s.m.i. 
 

  Titolare: Sigma-Tau I.F.R. SpA - Viale Shakespeare, 47 00144 Roma 
  Specialita' medicinale: SYNACTHEN 
  Confezioni e numero di AIC: 1 mg/ml sosp. iniett. a rilascio  prol.
per uso IM , 1 fiala 1 ml - AIC n. 020780021 
  Grouping di n. 12 variazioni apportate ai sensi del Regolamento  CE
n. 1234/2008, cosi' come modificato dal Regolamento (UE) n. 712/2012: 
  Cod. pratica: N1B/2013/3098 
  Var. n. 1: IB unforseen: B.II.d.1.z: Change  in  the  specification
parameters and/or limits of the finished product: Other (Appearance). 
  Var. n. 1: IB (upgraded): B.II.d.1.h: Change in  the  specification
parameters and/or limits for the  finished  product:  Update  of  the
dossier to comply with the provisions of an updated general monograph
of the Ph. Eur for the finished product (Change in the limit  of  the
test Extractable volume from "1.0-1.2 ml" to "not less than 1.0 ml"). 
  Var. n. 1: IB (upgraded): B.II.d.1.a: Change in  the  specification
parameters and/or limits for  the  finished  product:  Tightening  of
specification limits (Tightening of specification limits for the test
"Degradation products of Thetracosactide"). 
  Var. n. 1: IA: B.II.d.1.c: Change in the  specification  parameters
and/or  limits  for  the  finished  product:  Addition   of   a   new
specification parameter to the specification with  its  corresponding
test method (addition of  the  parameter  "Identification  of  Benzyl
Alcohol by RR-LC" to the release specification only). 
  Var. n. 1: IA: B.II.d.1.c: Change in the  specification  parameters
and/or  limits  for  the  finished  product:  Addition   of   a   new
specification parameter to the specification with  its  corresponding
test method (addition of the parameter "Assay of  Benzyl  Alcohol  by
RR-LC" both at release and at shelf-life). 
  Var. n. 1: IA: B.II.d.1.d: Change in the  specification  parameters
and/or limits for the finished product: Deletion of a non-significant
parameter (e.g. deletion of an obsolete parameter such as  odour  and
taste or identification test for a colouring or flavouring  material)
(deletion of the parameter "Assay of Benzyl Alcohol by HPLC" both  at
release and at shelf-life). 
  Var. n. 1: IA: B.II.d.1.c: Change in the  specification  parameters
and/or  limits  for  the  finished  product:  Addition   of   a   new
specification parameter to the specification with  its  corresponding
test method (addition of the parameter "Sterility" to the shelf  file
specifications, to be performed during the stability studies  at  the
end of the investigated storage period). 
  Var. n. 1:  IB:  B.II.d.2.d:  Change  in  test  procedure  for  the
finished product.  Other  changes  to  a  test  procedure  (including
replacement or addition) (replacement of  the  TLC  method  used  for
Identity Tetracosactide). 
  Var. n. 1:  IB:  B.II.d.2.d:  Change  in  test  procedure  for  the
finished product:  Other  changes  to  a  test  procedure  (including
replacement or addition) (replacement of the  HPLC  method  used  for
Identity, Assay and Degradation product of Tetracosactide) 
  Var. n. 1:  IB:  B.II.d.2.d:  Change  in  test  procedure  for  the
finished product:  Other  changes  to  a  test  procedure  (including
replacement or addition) (replacement of the HPLC method used for the
quantification of Benzaldehyde, the  degradation  product  of  Benzyl
alcohol). 
  Var. n. 1: IB (upgraded): B.II.f.1.a.1 Change in the shelf-life  or
storage conditions of the finished product: Reduction  of  the  shelf
life of the finished product, As packaged for sale (Reduction of  the
shelf life of the finished product from 36 months to 24 months). 
  Var. n. 1: IB (upgraded) B.II.d.2.a: Change in test  procedure  for
the finished product: Minor changes to  an  approved  test  procedure
(Minor change to the  analytical  method  for  the  test  "Sterility"
detailed in  Ph.  Eur.  monograph  2.6.1,  passing  from  the  Direct
inoculation" technique to the "Membrane filtration" technique). 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta. Decorrenza della modifica: dal giorno
successivo alla data di pubblicazione nella Gazzetta Ufficiale. 

                     Direttore affari regolatori 
                       dott.ssa Mirella Franci 

 
T14ADD11878