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

  Titolare: Recordati Industria Chimica e Farmaceutica S.p.A.  -  Via
Matteo Civitali, 1 - Milano. 
  Specialita' Medicinale: LOMEXIN 
  Confezioni e Numeri di AIC: 2% crema - tubo 30 g (AIC n. 026043012) 
  e 2% crema  vaginale  -  tubo  78  g  con  1  applicatore  (AIC  n.
026043277) 
  Specialita' Medicinale: FALVIN 
  Confezioni e Numeri di AIC: 2% crema - tubo 30 g (AIC n. 025982012) 
  e 2% crema  vaginale  -  tubo  78  g  con  1  applicatore  (AIC  n.
025982226) 
  Modifiche apportate in accordo al Regolamento 1234/2008/CE e s.m.i. 
  Codice pratica: N1B/2021/822 
  Grouping of variations costituito da: 
  B.II.b.3.a Type IB:  Minor  change  in  the  manufacturing  process
(Change of  the  temperature  in  the  preparation  of  fenticonazole
nitrate solution from 80°C to 75°C). 
  B.II.b.3.a Type IB:  Minor  change  in  the  manufacturing  process
(Change of the quantity of purified water added for  the  preparation
of the aqueous phase from 150 kg to 140 kg). 
  B.II.b.3.a Type IB:  Minor  change  in  the  manufacturing  process
(Addition of the target temperature of not lower than 70°C during the
preparation of the emulsion). 
  B.II.b.3.a Type IB:  Minor  change  in  the  manufacturing  process
(Change of the final temperature of the bulk  cream  at  the  end  of
cooling phase from 40°C to 27°C). 
  B.II.b.3.a Type IB:  Minor  change  in  the  manufacturing  process
(Addition of a reference cooling time (150 minutes)  at  the  end  of
emulsifying operation unit). 
  B.II.b.5.b Type IA: Addition of a new  in-process  test  and  limit
(Addition  of  the  appearance  of  fenticonazole  nitrate   solution
preparation after dissolution). 
  B.II.b.5.b Type IA: Addition of a new  in-process  test  and  limit
(Addition of the appearance of disodium edetate solution  preparation
after dissolution). 
  B.II.b.5.b Type IA: Addition of a new  in-process  test  and  limit
(Addition of  the  bulk  final  weight  after  the  addition  of  the
pre-heated water in emulsion preparation). 
  B.II.b.5.b Type IA: Addition of a new  in-process  test  and  limit
(Addition of the closure integrity test for the tubes at the  end  of
filling phase). 
  B.II.b.5.b Type IA: Addition of a new  in-process  test  and  limit
(Addition of the closure suitability test for the boxes at the end of
secondary packaging). 
  B.II.b.3.z Type IB:  Minor  change  in  the  manufacturing  process
(Addition of the holding time for the bulk cream  after  the  cooling
step up to the end of the filling step). 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta. 
  Decorrenza delle modifiche: dal giorno successivo alla  data  della
pubblicazione in Gazzetta Ufficiale. 

                           Un procuratore 
                      dott.ssa Annarita Franzi 

 
TX21ADD8384