Modifica secondaria di un'autorizzazione all'immissione in  commercio
  di una specialita' medicinale per uso umano. Modifica apportata  ai
  sensi del Regolamento CE n. 712/2012 

  Titolare: Bayer S.p.A.,  con  sede  e  domicilio  legale  in  viale
Certosa n. 130, 20156 (Milano). Codice fiscale e  partita  I.V.A.  n.
05849130157. 
  Specialita' medicinale: GYNO-CANESTEN MONODOSE. 
  «500 mg capsula molle vaginale» 1 capsula - A.I.C. n. 043850015. 
  Modifica apportata ai sensi del regolamento CE n. 712/2012. 
  Procedura europea n. FI/H/865/IB/001/G. 
  Pratica n. C1B/2018/701. 
  Grouping of Variations Type IA/IB: 
    Variation Type  IB:  B.II.a.3.b.1,  Changes  in  the  composition
(excipients) of the finished product; 
    Variation Type IB:  B.II.b.1.e,  Replacement  or  addition  of  a
manufacturing site for part or all of the manufacturing process o the
finished product; 
    Variation Type IA: B.II.b.2.a, Change to importer, batch  release
arrangements and quality control testing of the finished product; 
    Variation  Type  IB:  B.II.b.3.a,  Change  in  the  manufacturing
process of the finished product, including intermediate used  in  the
manufacture of the finished product; 
    Variation  Type  IB:  B.II.b.4.a,  Change  in  the   batch   size
(including batch size ranges) of the finished product; 
    Variation Type IB: B.II.b.5.z,  Change  to  in-process  tests  or
limits applied during the manufacture of the finished product; 
    Variation Type IB: B.II.b.5.z,  Change  to  in-process  tests  or
limits applied during the manufacture of the finished product; 
    Variation Type IA: B.III.1.b.2, Submission of a new or update Ph.
Eur. certificate of suitability or deletion of Ph.  Eur.  certificate
of suitability; 
    Variation Type IA: B.III.1.b.4, Submission of a new or update Ph.
Eur. certificate of suitability or deletion of Ph.  Eur.  certificate
of suitability. 
  I lotti gia' prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta. 

                      Un procuratore dirigente 
                      dott.ssa Patrizia Sigillo 

 
TV18ADD8142