Modifiche secondarie di un'autorizzazione all'immissione in commercio
di medicinale per uso umano. Modifiche apportate ai sensi del D.L. 29
     dicembre 2007, n. 274 e 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: MOTILIUM 
  Confezioni e numeri di AIC: tutte - AIC 027015 
  Codice pratica: C1A/2016/1387 - MRP BE/H/0106/001-003, 009/IA/055 
  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 
  Medicinale: LYRINEL 
  Confezioni e numeri di AIC: tutte - AIC 036551 
  Codice pratica: C1A/2016/1392 - UK/H/0627/001-003/IA/033/G 
  B.III.2 a) 2. Change to comply with Ph. Eur.  or  with  a  national
pharmacopoeia of a Member State.  Change  of  specification(s)  of  a
former non EU Pharmacopoeial substance to fully comply with  the  Ph.
Eur.  or  with  a  national  pharmacopoeia   of   a   Member   State.
Excipient/active substance starting material. 
  Polyethylene oxide 200K, TG: DA: NF - A: NF/Ph.Eur. 
  Polyethylene oxide 2000K, TG DA: NF - A: NF/Ph.Eur. 
  Codice pratica: C1A/2016/787 - UK/H/0627/001-003/IA/031 
  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 
  Medicinale: REMINYL 
  Confezioni e numeri di AIC: capsule rigide a rilascio prolungato  -
AIC 034752 
  Codice pratica: C1A/2015/4112 - SE/H/0210/005-008/IA/064/G 
  B.II.d.1 z) Change in the specification parameters and/or limits of
the finished product 
  • Appearance F077: Capsule (size 1). DA: cap and body caramel  with
imprint "G24"; content: white to off-white pellets - A: cap and  body
caramel opaque  with  imprint  "G24";  content:  white  to  off-white
pellets 
  • Methods for Identification of galantamine IR, Identification  and
Assay of galantamine HPLC, Chromatographic  purity,  Dissolution  and
Uniformity of dosage units (Content uniformity). 
  DA:  F075:  AMD_PIRS2007_0100,   F076:   AMD_PIRS2008_0100,   F077:
AMD_PIRS2009_0100, F075: AMD_PLCS2248_0100, F076:  AMD_PLCS2249_0100,
F077:    AMD_PLCS2250_0100    -F075:     AMD_PDRS2052_0100,     F076:
AMD_PDRS2053_0200, F077: AMD_PDRS2054_0200, F075:  AMD_PCUS2022_0100,
F076: AMD_PCUS2023_0100, F077: AMD_PCUS2024_0100 
  A: F075:  DS-TMD-11257,  F076:  DS-TMD-11253,  F077:  DS-TMD-11250,
F075: DS-TMD-11290, F076:  DS-TMD-11286,  F077:  DS-TMD-11283,  F075:
DS-TMD-11290,   F076:   DS-TMD-11286,   F077:   DS-TMD-11283,   F075:
DS-TMD-11270,   F076:   DS-TMD-12024,   F077:   DS-TMD-12026,   F075:
DS-TMD-11280, F076: DS-TMD-11277, F077: DS-TMD-11273 
  • Chromatographic purity Limit: DA: a. Each  specified  degradation
product - A: a. Each specified identified degradation product 
  • Dissolution Limit at Shelf life after 4 hours. DA 53 - 70 % -  A:
50 - 70 % 
  • Microbial purity Release Test frequency. DA: monitoring frequency
allowed (every 10th batch with a minimum  of  one  batch  per  year),
based on a microbiological risk assessment - A: monitoring  frequency
allowed (one  batch  per  year),  based  on  a  microbiological  risk
assessment 
  Codice pratica: C1A/2016/994 - SE/H/0210/005-008/IA/065/G 
  B.III.1  b)  2.  European   Pharmacopoeial   TSE   Certificate   of
suitability       for       an       active        substance/starting
material/reagent/intermediate/or excipient. 
  • New certificate for a  starting  material/reagent/intermediate/or
excipient from a new or  an  already  approved  manufacturer:  R1-CEP
2000-029-Rev 05, R1-CEP 2001-424-Rev 03, R1-CEP 2000-045-Rev 03 
  • Updated certificate from an already  approved  manufacturer.  DA:
R1-CEP 2003-172-Rev 00 - A: R1-CEP 2003-172-Rev 01 
  • Deletion of certificates (in case multiple certificates exist per
material): R1-CEP 2004-022-Rev 00 
  Medicinale: TOPAMAX 
  Confezioni e numeri di AIC: 15-25-50 mg capsule rigide - AIC 032023 
  Codice pratica: C1A/2015/1580 - MRP SE/H/110/001-004,007-009/IA/77 
  B.I.a).1. a) Change in manufacturer of a starting material used  in
the manufacturing process of the active substance where no  Ph.  Eur.
Certificate of Suitability is  part  of  the  approved  dossier.  The
proposed manufacturer is part of the same pharmaceutical group as the
currently     approved     manufacturer:     Supplier     for     the
diacetone--D-fructose   starting   material   Zhejiang    Cheng    Yi
Pharmaceutical Co., Ltd., 
  DA: 118 Hua Gong Road, Dongping, Dongtou, Zhejiang, China 325700 
  A: 118 Hua Gong Road, Dongping, Dongtou, Zhejiang, China  325700  -
328, South Xian'an Road, Huai'an, Jiangsu, China 
  Medicinale: RISPERDAL 
  Confezioni e numeri di AIC: tutte - AIC 028752 
  Codice pratica: C1B/2015/3465 - MRP DE/H/2184/002-016/IB/054 
  C.I.11 z) Change to the risk management plan. Other variation. 
  DA: Version 2.0, issue date May 2014 - A: Version 3.0, Issue  date:
October 2015 
  Confezioni e numeri di AIC: 1 mg/ml soluzione orale - AIC 028752 
  Codice pratica: C1B/2016/1518 - MRP DE/H/2184/008/IB/056 
  B.II.f.1 d) Change in storage conditions of the finished product. 
  DA: Non conservare a temperatura superiore ai 30°C. Non  congelare.
Conservare nella confezione originale per  proteggere  il  medicinale
dalla luce e dall'umidita'. 
  A: Non conservare a temperatura superiore ai 30°C. Non  refrigerare
o congelare. 
  I lotti gia' prodotti possono essere mantenuti  in  commercio  fino
alla data di scadenza indicata in etichetta. 

                           Un procuratore 
                        dott. Marco Martelli 

 
TX16ADD7551