Olysio

simeprevir

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The marketing authorisation for Olysio has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Olysio : EPAR - Summary for the public BG = bălgarski 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public ES = español 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public CS = čeština 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public DA = dansk 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public DE = Deutsch 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public ET = eesti keel 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public EL = elliniká 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public FR = français 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public IT = italiano 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public LV = latviešu valoda 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public LT = lietuvių kalba 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public HU = magyar 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public MT = Malti 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public NL = Nederlands 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public PL = polski 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public PT = português 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public RO = română 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public SK = slovenčina 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public SL = slovenščina 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public FI = suomi 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public SV = svenska 2014-06-04 2018-05-23
Olysio : EPAR - Summary for the public HR = Hrvatski 2014-06-04 2018-05-23
Name Language First published Last updated
Olysio : EPAR - Risk-management-plan summary (English only) 2014-06-04 2018-05-23

This EPAR was last updated on 23/05/2018 .

Authorisation details

Product details

Product details for Olysio
NameOlysio
Agency product numberEMEA/H/C/002777
Active substance

simeprevir

International non-proprietary name (INN) or common name

simeprevir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AE14
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Olysio
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision13
Date of issue of marketing authorisation valid throughout the European Union14/05/2014

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30 
B-2340 Beerse 
Belgium

Product information

Product information

08/02/2018  Olysio -EMEA/H/C/002777 -PSUSA/00010255/201705

Name Language First published Last updated
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23
Olysio : EPAR - Product Information EN = English 2014-06-04 2018-05-23

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23
Olysio : EPAR - All Authorised presentations EN = English 2014-06-04 2018-05-23

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

For hepatitis C virus (HCV) genotype specific activity.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Olysio : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-03-02 2018-05-23
Olysio-H-C-1438-A20-2777-0019 : EPAR - Assessment Report - Article 20 EN = English 2017-03-13 2018-05-23
Olysio-EMEA-H-C-PSUSA-00010255-201411 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation EN = English 2015-09-25 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23
Olysio : EPAR - Scientific Conclusion EN = English 2017-03-13 2018-05-23

Initial marketing-authorisation documents

Name Language First published Last updated
Olysio : EPAR - Public assessment report EN = English 2014-06-04 2018-05-23
CHMP summary of positive opinion for Olysio EN = English 2014-03-21 2018-05-23

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Olysio