Olysio
simeprevir
Table of contents
Overview
The marketing authorisation for Olysio has been withdrawn at the request of the marketing authorisation holder.
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List item
Olysio : EPAR - Summary for the public (PDF/548.55 KB)
First published: 04/06/2014
Last updated: 23/05/2018 -
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List item
Olysio : EPAR - Risk-management-plan summary (PDF/555.54 KB)
First published: 04/06/2014
Last updated: 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 NV
|
| Revision |
13
|
| Date of issue of marketing authorisation valid throughout the European Union |
14/05/2014
|
| Contact address |
Turnhoutseweg 30 |
Product information
08/02/2018 Olysio - EMEA/H/C/002777 - PSUSA/00010255/201705
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.