Modifica secondaria di un'autorizzazione all'immissione in  commercio
di una specialita' medicinale per uso umano.  Modifica  apportata  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: TORA-DOL 
  Confezioni e Numeri di AIC: 10 mg/ml soluzione iniettabile 6  fiale
da 1 ml (AIC n. 027253018) 
  Modifica apportata in accordo al Regolamento 1234/2008/CE e s.m.i. 
  Codice pratica: N1B/2022/561 
  Grouping  of   variations   costituito   da:   var.IB   B.II.b.1.f:
Replacement of Recordati  Industria  Chimica  e  Farmaceutica  S.p.A.
(Milano)  with  Biologici  Italia  Laboratories  S.r.l.  (Masate)  as
manufacturing site for production (including  primary  packaging)  of
the finished product; var.IAIN B.II.b.2.c.2:  Addition  of  Biologici
Italia Laboratories S.r.l. (Masate) as responsible for batch  release
and batch control  testing  of  the  finished  product;  var.IA  A.7:
Deletion of the manufacturing  site  Recordati  Industria  Chimica  e
Farmaceutica S.p.A. (Milano)  for  the  secondary  packaging  of  the
finished product; var.IB  B.II.a.3.b.1:  Change  in  the  composition
(excipients) of the finished product, to declare the fixed amount  of
NaOH used in the manufacturing process, to  adjust  the  pH.;  var.IB
B.II.b.3.a: Change in  the  overfilling  volume;  var.IB  B.II.b.3.a:
Inclusion of bubble nitrogen after every addition of component in the
solution; var.IB B.II.b.3.a: Addition of pre-filtration step;  var.IA
B.II.b.5.b: Addition of Final volume check as IPC; var.IB B.II.b.5.z:
Change of the range of the filled volume; var.IA B.II.b.5.b: Addition
of Ampoule welding height test as IPC; var. IA B.II.b.5  b)  Addition
of Bioburden test as IPC, var.IB B.II.b.5.z: Replacement of the  leak
test by vacuum with leak test performed by HVLD;  var.IB  B.II.b.3.z:
Addition of Holding Times; var.IA B.II.d.2.a: Minor  changes  in  the
HPLC analytical procedure for Assay; var.IA B.II.d.2.a: Minor changes
in the HPLC  analytical  procedure  for  Related  substances;  var.IA
B.II.e.2.b: Addition of the new specification parameter  "appearance"
of  the  immediate  packaging  of  the   finished   product;   var.IA
B.II.e.2.b: Addition of the new specification parameter  "dimensional
control (ampoule body diameter)" of the immediate  packaging  of  the
finished product. 
  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 

 
TX22ADD8126