Parte Seconda n. 92 del 4-8-2016
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
JANSSEN-CILAG S.P.A.
Sede legale: via M. Buonarroti, 23 - 20093 Cologno Monzese (MI)
(GU Parte Seconda n.92 del 4-8-2016)

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'umidità.
A: Non conservare a temperatura superiore ai 30°C. Non refrigerare
o congelare.
I lotti già prodotti possono essere mantenuti in commercio fino
alla data di scadenza indicata in etichetta.

Un procuratore
dott. Marco Martelli


TX16ADD7551