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AstraZeneca

Olysio
simeprevir

Package leaflet: Information for the patient


OLYSIO 150 mg hard capsules

simeprevir


image

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What OLYSIO looks like and contents of the pack

The hard capsules are white, with ‘TMC435 150’ printed in black ink.

OLYSIO is supplied in push-through blister strips of 7 capsules. The days of the week are printed on the blister strip.

OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters). Not all pack sizes may be marketed.


Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium


Manufacturer

Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


Medicinal product no longer authorised

België/Belgique/Belgien Janssen-Cilag NV Antwerpseweg 15-17

B-2340 Beerse

Tel/Tél: +32 14 64 94 11

Lietuva

UAB "JOHNSON & JOHNSON"

Geležinio Vilko g. 18A LT-08104 Vilnius

Tel: +370 5 278 68 88


България

„Джонсън & Джонсън България” ЕООД ж.к. Младост 4

Бизнес Парк София, сграда 4

София 1766

Тел.: +359 2 489 94 00

Luxembourg/Luxemburg Janssen-Cilag NV Antwerpseweg 15-17

B-2340 Beerse Belgique/Belgien

Tél/Tel: +32 14 64 94 11


Česká republika Janssen-Cilag s.r.o. Karla Engliše 3201/06

CZ-150 00 Praha 5 - Smíchov

Tel: +420 227 012 227

Magyarország Janssen-Cilag Kft. Nagyenyed u. 8-14

H-Budapest, 1123

Tel.: +36 1 884 2858


Danmark

Janssen-Cilag A/S Bregnerødvej 133

DK-3460 Birkerød Tlf: ++45 45 94 82 82

Malta

AM MANGION LTD.

Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000

Tel: +356 2397 6000


Deutschland

Janssen-Cilag GmbH

Johnson & Johnson Platz 1 D-41470 Neuss

Tel: +49 2137 955-955

Nederland

Janssen-Cilag B.V.

Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111

Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Lõõtsa 2

EE-11415 Tallinn Tel: +372 617 7410

Norge

Janssen-Cilag AS Postboks 144

NO-1325-Lysaker Tlf: +47 24 12 65 00


Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.

Λεωφόρος Ειρήνης 56

GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206B A-1020 Wien

Tel: +43 1 610 300


España

Janssen-Cilag, S.A.

Paseo de las Doce Estrellas, 5-7 E-28042 Madrid

Tel: +34 91 722 81 00

Polska

Janssen-Cilag Polska Sp. z o.o. ul. Iłżecka 24

PL-02-135 Warszawa Tel.: +48 22 237 60 00


France

Janssen-Cilag

1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 Tél: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal

Janssen-Cilag Farmacêutica, Lda.

Estrada Consiglieri Pedroso, 69 A Queluz de Baixo

PT-2734-503 Barcarena

Tel: +351 21 43 68 835


Hrvatska

Johnson & Johnson S.E. d.o.o.

Medicinal product no longer authorised

Oreškovićeva 6h 10010 Zagreb

Tel: +385 1 6610 700

România

Johnson & Johnson România SRL

Str. Tipografilor nr. 11-15

Clădirea S-Park, Corp B3-B4, Etaj 3 013714 Bucureşti, ROMÂNIA

Tel: +40 21 207 1800


Ireland

Janssen-Cilag Ltd.

50-100 Holmers Farm Way High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Tel: +44 1 494 567 444

Slovenija

Johnson & Johnson d.o.o.

Šmartinska cesta 53 SI-1000 Ljubljana

Tel: +386 1 401 18 30


Ísland

Janssen-Cilag AB

c/o Vistor hf. Hörgatúni 2

IS-210 Garðabær

Sími: +354 535 7000

Slovenská republika Johnson & Johnson s.r.o. CBC III, Karadžičova 12 SK-821 08 Bratislava

Tel: +421 232 408 400


Italia

Janssen-Cilag SpA

Via M.Buonarroti, 23

I-20093 Cologno Monzese MI Tel: +39 02 2510 1

Suomi/Finland

Janssen-Cilag Oy

Vaisalantie/Vaisalavägen 2 FI-02130 Espoo/Esbo

Puh/Tel: +358 207 531 300

Κύπρος

Βαρνάβας Χατζηπαναγής Λτδ, Λεωφόρος Γιάννου Κρανιδιώτη 226

Λατσιά

CY-2234 Λευκωσία Τηλ: +357 22 207 700

Sverige

Janssen-Cilag AB Box 4042

SE-16904 Solna

Tel: +46 8 626 50 00


Latvija

UAB "JOHNSON & JOHNSON" filiāle Latvijā Mūkusalas iela 101

Rīga, LV-1004

Tel: +371 678 93561

United Kingdom

Janssen-Cilag Ltd.

50-100 Holmers Farm Way High Wycombe

Buckinghamshire HP12 4EG - UK

Tel: +44 1 494 567 444


This leaflet was last revised in {month YYYY}.


Medicinal product no longer authorised

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