Modifica secondaria di un'autorizzazione all'immissione in  commercio
              di specialita' medicinali per uso umano. 
 

  Titolare:  Abbott  S.r.l.,  S.R.  148  Pontina  km  52  snc,  04011
Campoverde di Aprilia (LT) 
  Medicinale: FEMOSTON 
  Confezioni e numeri di A.I.C.: 
  2/10 mg compresse rivestite con film - Astuccio da  28  cpr  -  AIC
033639016/M 
  2/10 mg compresse rivestite con film - Astuccio da 3  cicli  da  28
cpr - AIC 033639028/M 
  Modifica apportata ai sensi del Regolamento (CE) n. 1234/2008: 
  Codice  Pratica:  C1B/2012/1851  -  MRP  n.  NL/H/0124/001/IB/033/G
conclusasi a livello europeo il 5 settembre 2012 - Grouping di: 
  Variazioni relative alle  compresse  film  rivestite  da  2  mg  di
Estradiolo: 
  - 2 Variazioni tipo IB n. B.II.d.2.d - Change in test procedure for
the finished product - Other changes to a test  procedure  (including
replacement  or  addition)  -  Change  in  the  analytical   methods:
Identity, assay, purity; Dissolution. 
  - 1 Variazione tipo IB  Art.  5  n.  B.II.d.1.z  -  Change  in  the
specification parameters and/or limits  of  the  finished  product  -
Other variation  -  Change  in  the  analytical  methods:  Uniformity
testing 
  - 3 Variazioni tipo IB n. B.II.d.1.z - Change in the  specification
parameters and/or limits of the finished product - Other variation  -
Change in the specification of the impurities - Update of  impurities
related to Estradiol; Change from routine to non-routine testing  for
the identity test of the colour additives;  Change  from  routine  to
non-routine testing for the microbiological purity. 
  Variazioni relative alle  compresse  film  rivestite  da  2  mg  di
Estradiolo e 10 mg di Didrogesterone: 
  - 2 Variazioni tipo IB n. B.II.d.2.d - Change in test procedure for
the finished product - Other changes to a test  procedure  (including
replacement  or  addition)  -  Change  in  the  analytical   methods:
Identity, assay, purity; Dissolution. 
  - 1 Variazione tipo IB  Art.  5  n.  B.II.d.1.z  -  Change  in  the
specification parameters and/or limits  of  the  finished  product  -
Other variation  -  Change  in  the  analytical  methods:  Uniformity
testing 
  - 1 Variazione tipo IA n. B.II.d.1.c - Change in the  specification
parameters and/or limits of the finished product - Addition of a  new
specification parameter to the specification with  its  corresponding
test method - Change in the specifications:  Introduction  of  second
identity test by UV. 
  - 4 Variazioni tipo IB n. B.II.d.1.z - Change in the  specification
parameters and/or limits of the finished product - Other variation  -
Change from routine to non-routine testing for the identity  test  of
colour additives; Change from routine to non-routine testing for  the
microbiological purity; Change in the specification of the impurities
-  Update  of  impurities  related  to  Estradiol;  Change   in   the
specification of the impurities - Update  of  impurities  related  to
Dydrogesterone. 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta. 

                           Un procuratore 
                dott.ssa Maria Antonietta Compagnone 

 
T12ADD15063