Modifiche secondarie di un'autorizzazione all'immissione in commercio
di medicinale per uso umano. Modifiche apportate ai sensi del  D.Lgs.
                          219/2006 e s.m.i. 
 

  Ai sensi della  Determinazione  AIFA  25  agosto  2011  si  informa
dell'avvenuta approvazione  delle  seguenti  modifiche  apportate  in
accordo al regolamento (CE) 1234/2008: 
  Titolare AIC: Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina 
  Codice pratica: N° N1B-2021-1621 
  Specialita' medicinale: ACTUALENE - DOSTINEX - CABASER 
  Confezioni e numeri di AIC: ACTUALENE: AIC n. 033359; 
  DOSTINEX: AIC n. 028988; 
  CABASER: AIC n. 031128 (tutte le confezioni) 
  Tipologia variazione: Grouping di variazioni: 
  Type IA (A.4): update in the address (postal  code  from  20090  to
20053) to the currently registered drug substance manufacturing  site
i.e. Olon S.p.A.; Type IB (B.I.b.2.e): Added ICP-OES as an  alternate
method for controlling Palladium  in  Intermediate  I.  In-house  GLC
method for Residual Solvents in drug substance is replaced with a new
in-house  GLC  method;  Type  IA   (B.I.b.1.d):   Deletion   of   GLC
identification test from the Ethyl isocynate specification;  Type  IA
(B.I.b.1.c):  Addition  of  a  new  specification  parameter  to  the
specification  with  its  corresponding  test  method  for   selected
reagents, solvents and  auxiliary  materials;  Type  IA  (B.I.b.2.a):
Minor change to  an  approved  test  procedure  for  Sodium  Sulphate
Anhydrous (identification test method). 
  Type  IB  unforeseen  (B.I.b.1.z):  Changes  to   the   description
specification  for  selected   reagents,   solvents   and   auxiliary
materials.  The  variation  is  classified  as  Type  IB   unforeseen
z-variation because it is not included in the  commission  regulation
(EC) No 1234/2008 classification. The change has been  classified  as
Type IB as it dose not have an adverse impact on the quality,  safety
and  efficacy  of  Cabergoline  Tablets  1  mg  and  2  mg;  Type  IB
(B.I.b.2.c): Replacement of the Identification test method (AAS)  for
Palladium 5% on Charcoal with an ICP-OES test method.  The  variation
is classified as  Type  IB  as  a  condition  is  not  met;  Type  IB
unforeseen (B.I.c.1.z):  Changes  to  the  description  of  the  bulk
container closure system and contemporizing of the container  closure
information including provision  of  an  updated  specification.  The
variation is classified as Type IB unforeseen z-variation because  it
is not included  in  the  commission  regulation  (EC)  No  1234/2008
classification; Type IB unforeseen (B.I.a.2.z): Changes  to  Lysergic
Acid   (Regulatory   Starting   Material)    Manufacturing    Process
Information. The variation is classified  as  a  Type  IB  unforeseen
z-variation because it is not included in the  commission  regulation
(EC) No 1234/2008 classification. 
  Modifica apportata: Modifiche e aggiustamenti  delle  specifiche  e
dei metodi di prova di intermedi di produzione,  reagenti,  solventi,
materiali ausiliari e del materiale di partenza della sostanza attiva
(acido lisergisco) ed eliminazione del sito di produzione di sostanza
attiva Euticals S.p.A (conosciuto anche come Poli  Industria  Chimica
S.p.A). 
  I lotti gia'  prodotti  alla  data  di  pubblicazione  in  Gazzetta
Ufficiale possono essere mantenuti in commercio  fino  alla  data  di
scadenza indicata in etichetta. 

                           Un procuratore 
                           Federica Grotti 

 
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