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: PEVARYL 
  Confezioni e numeri di AIC: 50 mg ovuli - AIC n. 023603083; 150  mg
ovuli - AIC n. 023603107; 150 mg ovuli a rilascio prolungato - AIC n.
023603158 
  Codice pratica: N1B/2016/1993 
  B.II.b.1. Replacement or addition of a manufacturing site for  part
or all of the manufacturing process of the finished product 
  a) Secondary packaging site 
  b) Primary packaging site 
  e) Site where any manufacturing  operation(s)  take  place,  except
batch release, batch control, primary and  secondary  packaging,  for
non-sterile medicinal products 
  B.II.b.2 c) 2. Change to importer, batch release  arrangements  and
quality control testing of the  finished  product  -  Replacement  or
addition of a manufacturer responsible for importation  and/or  batch
release - Including batch control/testing 
  DA: Xian-Janssen Pharmaceutical Ltd., Xian, Shaanxi Province, China 
  A: Site 1 - Xian-Janssen Pharmaceutical Ltd., Xian Shaanxi Province
China; Site 2 - Lusomedicamenta Sociedade Tecnica Farmacêutica, S.A.,
Queluz, Portugal 
  B.II.b.3 a) Change in the manufacturing  process  of  the  finished
product, including an intermediate used in  the  manufacture  of  the
finished product - Minor change in the manufacturing process 
  DA: Xian-Janssen: separate melting vessel A: Xian-Janssen: separate
melting  vessel;  Lusomedicamenta:  melting  in   processor   vessel,
stainless steel sieve between processor vessel and holding tank 
  B.II.b.4. b) Change in the batch size (including batch size ranges)
of the finished product - Downscaling down to 10-fold 
  DA: 50 mg and  150  mg  =  432  kg;  150  mg  depot  =  270  kg  A:
Xian-Janssen = no change; Lusomedicamenta: 50 mg and 150 mg  =  310.5
kg; 150 mg depot = 270 kg 
  Medicinale: PEVARYL 
  Confezioni e numeri di AIC: 150 mg ovuli a  rilascio  prolungato  -
AIC n. 023603158 
  Codice pratica: N1B/2016/1995 
  B.II.c.1. Change in the specification parameters and/or  limits  of
an excipient - Deletion of a nonsignificant  specification  parameter
(e.g. deletion of an obsolete parameter) 
  DA: Residual heavy metals, lead, and arsenic tested 
  A: Residual heavy metals, lead, and arsenic tested deleted 
  B.II.c.1 z) Change in the specification parameters and/or limits of
an excipient - other variation 
  DA: viscosity: 90-140 mPa·s; viscometer/method: Contraves Rheomat 
  A:  viscosity:  4000-6500  mPa·s;   viscometer/method:   Ph.   Eur.
rotational (Brookfield) 
  B.II.c.2 d) Change in test  procedure  for  an  excipient  -  Other
changes to a test procedure (including replacement or addition) 
  DA: Microbial purity testing: non-harmonized Ph. Eur. Monographs 
  A: Microbial purity testing: harmonized Ph. Eur. Monographs 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Un procuratore 
                    dott.ssa Alessandra Sinibaldi 

 
TX16ADD10676