Modifiche secondarie di un'autorizzazione all'immissione in commercio
di medicinale per uso umano, apportata ai sensi del D.L. 29  dicembre
2007,  n.  274.  Modifiche  apportate  ai   sensi   del   regolamento
                         1234/2008/CE e s.m. 
 

  Titolare AIC: Janssen-Cilag S.P.A. 
  Ai sensi della determinazione AIFA 18  dicembre  2009,  si  informa
dell'avvenuta approvazione delle seguenti variazioni: 
  Medicinale: TOPAMAX 
  Confezioni e numeri di AIC: tutte - AIC AIC 032023 
  Codice pratica: C1B/2015/652- SE/H/0110/001-04,07-09/IB/072 
  C.I.11.z Introduction of changes to the obligations and  conditions
of a marketing authorization, including the risk management plan 
  DA: RMP v3 dated 05th March 2014 - A: RMP v4 dated 19th March 2014 
  Confezioni  e  numeri  di  AIC:  15-25  mg  capsule   -   AIC   AIC
032023(083)-(095) 
  Codice pratica: C1B/2015/815 - SE/H/110/007-009/IB/73/G 
  B.III.1  Submission  of  a  new  or  updated  Eur.  certificate  of
suitability or deletion of Ph. Eur. certificate of suitability for an
excipient (gelatin) 
  DA: R1-CEP 2000-027-Rev 01 - A: R1-CEP 2000-027-Rev 02 
  DA: R1-CEP 2001-332-Rev 01 - A: R1-CEP 2001-332-Rev 02 
  Medicinale: RISPERDAL 
  Confezioni e numeri di AIC: 1-2-3-4 mg compresse rivestite con film
e 1 mg/ml gocce orali, soluzione - AIC 028752 
  Codice pratica: C1A/2015/1024 - DE/H/2184/002-008/IA/044 
  B.II.b.1.a Addition of a manufacturing site for part or all of  the
manufacturing process of the finished  product.  Secondary  packaging
site: Janssen Pharmaceutica NV 
  Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium 
  Confezioni e numeri di AIC: 1-2 mg compresse orodispersibili -  AIC
028752 
  Codice pratica: C1A/2015/1279 - DE/H/2184/009-012, 016/IA/045/G 
  A.5 Change  in  the  address  of  a  manufacturer/importer  of  the
finished product (including batch release or quality control  testing
sites) 
  DA: Janssen-Cilag S.P.A. Via C. Janssen, Borgo S. Michele  -  04010
Latina, Italy 
  A: Janssen-Cilag S.P.A. Via C. Janssen, Borgo S.  Michele  -  04100
Latina, Italy 
  B.II.b.1.a Addition of a manufacturing site for part or all of  the
manufacturing process of the finished  product.  Secondary  packaging
site: Janssen Pharmaceutica NV 
  Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium 
  B.II.d.2.a Change in test procedure for the finished product. Minor
changes to an approved test procedure 
  DA: Test method DS-TMD-1277. System Suitability: Resolution  factor
(R) between R082355/T001624 and R076960 in  Selectivity  Solution  is
greater than or equal  to  1.5  as  calculated  by  the  current  USP
(Section < 621 > Peak Width at base) at  beginning  and  end  of  the
analysis sequence. 
  A: Test Method DS-TMD-1277. System Suitability:  Resolution  factor
(R) between R082355/T001624 and R076960 in  Selectivity  Solution  is
greater than or equal  to  1.8  as  calculated  by  the  current  USP
(Section < 621 > Peak Width at base) at  beginning  and  end  of  the
analysis sequence. 
  Medicinale: RISPERDAL 
  Confezioni e numeri di AIC: 25-37,5-50 mg/2ml  polvere  e  solvente
per sospensione iniettabile a rilascio prolungato - AIC 028752 
  Codice pratica: C1A/2015/1417 - DE/H/2184/013-015/IA/46/G 
  B.II.b.1.a Addition of a manufacturing site for part or all of  the
manufacturing process of the finished  product.  Secondary  packaging
site: Janssen Pharmaceutica NV 
  Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium 
  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: 
  - Addition of a new microsphere filling line at Alkermes, Inc. with
a subsequent new automated fill verification in-process test. 
  - Manufacturing bulk line #1 used in the manufacture of risperidone
microspheres has been decommissioned. 
  B.II.b.5.b Change to in-process test(s) or  limits  applied  during
the manufacture of the finished product. Addition of  a  new  test(s)
and limits: in-process test  of  the  weight  of  each  vial  is  now
performed in-line. It is measured after the risperidone  microspheres
are filled into a vial. 
  B.II.d.2.a Change in test procedure for the finished product. Minor
changes to an approved test procedure. Correction to  the  previously
filed endotoxin analytical method for the diluent: 
  DA: Method D, kinetic chromogenic of Ph. Eur. 2.6.14 
  A: Method C, kinetic turbidimetric of Ph. Eur. 2.6.14 
  Medicinale: EPREX 
  Confezioni e numeri di AIC: tutte - AIC 027015 
  Codice pratica: C1A/2015/890 - FR/H/003/09-10, 13-014/IAin/114 
  B.II.b.1.a Addition of a manufacturing site for part or all of  the
manufacturing process of the finished  product.  Secondary  packaging
site: Janssen Pharmaceutica NV 
  Rue du Bois de la Hutte 7, 7110 La Louviere, Belgium 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Un procuratore 
                    dott.ssa Alessandra Sinibaldi 

 
T15ADD9175