Modifica secondaria di un'autorizzazione all'immissione in  commercio
di una specialita' per uso umano. Modifica  apportata  ai  sensi  del
  Regolamento 1234/2008/CE come modificato dal Regolamento 712/2012 
 

  Specialita' medicinale, Confezione e numero A.I.C.: 
  MOTICLOD - 100 mg/3,3 ml soluz. iniet. - 6 fl - AIC n. 035044015 
  MOTICLOD 100 mg/3,3 ml soluz. iniet.- 12 fl - AIC n 035044027 
  MOTICLOD 300 mg/10 ml soluz. per  infus.  Ev  -  6  fl.  -  AIC  n.
035044039 
  Codice Pratica N. N1B/2018/1316 
  Grouping di variazioni: Tipo IA  A.4  Change  in  the  name  and/or
address of: a manufacturer (including where relevant quality  control
testing sites); or an ASMF  holder;  or  a  supplier  of  the  active
substance, starting material, reagent or  intermediate  used  in  the
manufacture of the active substance (where specified in the technical
dossier) where no Ph. Eur. Certificate of Suitability is part of  the
approved dossier; or a  manufacturer  of  a  novel  excipient  (where
specified in the technical dossier)  da  Farchemia  S.r.l.  a  CORDEN
PHARMA BERGAMO S.p.A. manufacturer of API Clodronate disodium. 
  Tipo  IA  B.I.a.1  Change  in  the  manufacturer  of   a   starting
material/reagent/intermediate used in the  manufacturing  process  of
the active substance or change in the manufacturer  (including  where
relevant quality control testing  sites)  of  the  active  substance,
where no Ph. Eur. Certificate of Suitability is part of the  approved
dossier f) Changes to quality control testing  arrangements  for  the
active substance-replacement  or  addition  of  a  site  where  batch
control/testing: takes place: the analysis for Related Substances  by
HPLC according to the EP monograph (Ph. Eur. 2.2.29) is performed  by
Lab Analysis S.r.l. Via Europa, 5 -  27041  Casanova  Lonati  (PV)  -
Italy. 
  Tipo IB B.I.d.1 Change in  the  re-test  period/storage  period  or
storage  conditions  of  the  active  substance  where  no  Ph.  Eur.
Certificate of Suitability covering the retest period is part of  the
approved dossier a) Re-test period/storage  period  4.  Extension  or
introduction of a re-test period/storage  period  supported  by  real
time data: the proposed re-test period is 5 years. 
  Decorrenza della modifica: dal giorno successivo  alla  data  della
sua pubblicazione in G.U. 

                      L'amministratore delegato 
                     dott. Massimiliano Delfrate 

 
TX18ADD9871