Modifica  secondaria  di  un'A.I.C.  di  medicinale  per  uso  umano,
  apportata ai sensi del D.L. 29 dicembre 2007, n. 274. 

  Titolare A.I.C.: Janssen-Cilag S.p.a. 
  Modifica apportata ai sensi del Regolamento CE n. 1234/2008. 
  Ai sensi della determinazione AIFA 18  dicembre  2009,  si  informa
dell'avvenuta approvazione delle seguenti variazioni. 
Medicinale: TOPAMX 25-50-100-200 mg compresse rivestite con film. 
  Confezioni e numeri di A.I.C.: 60 compresse - A.I.C. n. 032023. 
  C1A/2010/4716 - MRP SE/H/110/1-4/IA/48 - B.II.d.1.d) Deletion of  a
non significant specification  parameter  of  the  finished  product:
(Identification of iron oxide). 
  C1B/2010/2495  -  MRP  SE/H/110/1-4/IB/49/G   -   B.II.b.1.a)-b)-e)
Addition of a manufacturing site for all of the manufacturing process
of the finished product & B.II.b.2.b).2 addition  of  a  manufacturer
responsible  for  patch  release,  including  batch  control/testing:
(Janssen-Cilag S.p.a., Borgo S. Michele, Latina). 
Medicinale: TOPAMX 15-25 mg capsule rigide. 
  Confezioni e numeri di A.I.C.: 60 capsule - A.I.C. n. 032023. 
  C1A/2010/4719 - MRP SE/H/110/7-8/IA/51/G: 
    B.II.c.4.a) Minor change in the synthesis of a non-pharmacopoeial
excipient (hard gelatin capsules); 
    A.5.b) Change in the name of a manufacturer (da: Cardinal  Health
PTS, LLC - a: Catalent Pharma solutions, LLC); 
    A.7 Deletion of a manufacturing site (Cilag AG Switzerland as  QC
testing); 
    B.II.b.1.a)-b) Replacement of a manufacturing site  for  part  of
the manufacturing process of the  finished  product  &  B.II.b.2.b).2
replacement  of  a  manufacturer  responsible  for   patch   release,
including batch  control/testing:  (Janssen-Cilag  S.p.a.,  Borgo  S.
Michele, Latina); 
    B.III.1.b.2-3  Submission  of  a  new  or  updated  Ph.Eur.   TSE
certificate of suitability for an excipient (gelatins). 
  C1B/2010/2499 - MRP SE/H/110/7-8/IB/52/G: 
    B.II.d.2 Change in test procedure  for  finished  product  -  b):
Replacement of: - HPLC methods for identification and assay of active
substance  and  degradation  compounds  and  for  content  uniformity
testing - CE method  for  the  assay  of  the  inorganic  degradation
products; - d) Deletion of the alternative IC method for the assay of
the inorganic degradation products; 
    B.II.d.1.a Change in the specification  limits  of  the  finished
product  (tightening  of  limits  for:  organic  degradation  product
RWJ-34826-000 and inorganic degradation product sulfamate). 
  I lotti gia' prodotti alla data  di  pubblicazione  nella  Gazzetta
Ufficiale possono essere mantenuti in commercio  fino  alla  data  di
scadenza indicata in etichetta. 

                           Un procuratore: 
                      dott.ssa Eleonora Roselli 

 
TC10ADD7640