Modifiche secondarie di un'autorizzazione all'immissione in commercio
di una specialita' medicinale per uso umano. Modifiche  apportate  ai
          sensi del Decreto legislativo 29/12/2007, n. 274 
 

  Medicinale: PEVISONE 
  Confezioni e numeri di AIC: 1,0% + 0,1% emulsione cutanea - AIC  n.
025036029 
  Codice pratica: N1B/2017/1678 
  B.I.b.1.b. Change in the specification parameters and/or limits  of
an active substance, starting material/intermediate/reagent  used  in
the manufacturing process of the active  substance  -  Tightening  of
specification limits 
  DA:  3.2.S.4.1:  Specification  limit  for  the  particle  size  of
triamcinolone acetonide Ph. Eur. (micronized) - Main part < 10 µm  A:
3.2.S.4.1: Specification limit for the particle size of triamcinolone
acetonide Ph. Eur. (micronized) - d90 ≤ 10 µm 
  B.I.b.2.e.  Change  in  test  procedure  for  active  substance  or
starting  material/reagent/intermediate  used  in  the  manufacturing
process of the active substance - Other changes to a  test  procedure
(including replacement or addition) for the  active  substance  or  a
starting material/intermediate 
  DA: 3.2.S.4.2: Visual microscopic examination of the particle  size
of triamcinolone acetonide Ph. Eur. (micronized) A: 3.2.S.4.2:  Laser
diffraction method for the determination  of  the  particle  size  of
triamcinolone  acetonide  Ph.  Eur.  (micronized)  -  Method  number:
DS-TMD-20870; Instrument: Malvern Mastersizer 3000; Dispersant:  0.1%
(w/v) polysorbate 80 in water 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Un procuratore 
                    dott.ssa Alessandra Sinibaldi 

 
TX17ADD10166