Olysio

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simeprevir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Olysio has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 23/05/2018

Authorisation details

Product details
Name
Olysio
Agency product number
EMEA/H/C/002777
Active substance
simeprevir
International non-proprietary name (INN) or common name
simeprevir
Therapeutic area (MeSH)
Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code
J05AE14
Additional monitoring

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

Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
14/05/2014
Contact address
Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

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

Contents

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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

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