Modifica secondaria di un'autorizzazione all'immissione in  commercio
di specialita' medicinale per uso umano. Modifica apportata ai  sensi
                 del regolamento (CE) N. 1234/2008. 
 

  Codice pratica: Codice Pratica: N1A/2011/2144 
    
  Titolare dell' AIC: AGIPS FARMACEUTICI srl 
  Specialita' medicinale: SUMMAFLOX 
  Confezione e numero di AIC: 
    
  250 mg compresse rivestite con film - 5 compresse AIC 040047019 
  500 mg compresse rivestite con film - 5 compresse AIC 040047021 
    
  Modifica apportata ai sensi del Regolamento ( CE ) 1234/2008 : 
  Grouping of Variations Tipo : 
  B.II.b.1) Replacement or addition of a manufacturing site for  part
or all of the manufacturing process of the finished product 
  B.II.b.1) Replacement or addition of a manufacturing site for  part
or all of the manufacturing process of the finished product 
  B.II.b.1) Replacement or addition of a manufacturing site for  part
or all of the manufacturing process of the finished product 
  B.II.b.4) Change in the batch size (including batch size ranges) of
the finished product 
  B.II.b.5) Change to in-process tests or limits applied  during  the
manufacture of the finished product 
  B.II.b.5) Change to in-process tests or limits applied  during  the
manufacture of the finished product 
  B.II.c.2) Change in test procedure for an excipient 
  B.II.c.1) Change in the specification parameters and/or  limits  of
an excipient 
  B.II.c.3) Change in source of an excipient or reagent with TSE risk 
  B.II.d.2) Change in test procedure for the finished product 
  B.II.e.2) Change in the specification parameters and/or  limits  of
the immediate packaging of the finished product 
  B.II.e.2) Change in the specification parameters and/or  limits  of
the immediate packaging of the finished product 
  B.II.b.4) Change in the batch size (including batch size ranges) of
the finished product 
  B.II.b.4) Change in the batch size (including batch size ranges) of
the finished product 
  Le confezioni del medicinale sopra indicate devono essere poste  in
commercio con gli stampati, cosi' come precedentemente autorizzati da
questa  amministrazione,  con  le  sole  modifiche   necessarie   per
l'adeguamento alla presente notifica. 
  Decorrenza della modifica : dal giorno successivo alla  data  della
sua Pubblicazione in G.U. 

                       L'amministratore unico 
                       dott. Giuseppe Radaelli 

 
T12ADD5072