Olysio

Withdrawn

This medicine's authorisation has been withdrawn

simeprevir

Overview

The marketing authorisation for Olysio has been withdrawn at the request of the marketing authorisation holder.

Olysio : EPAR - Summary for the public

Olysio : EPAR - Risk-management-plan summary

Product information

Olysio : EPAR - Product Information

Latest procedure affecting product information: PSUSA/00010255/201705

08/02/2018

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).

Olysio : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Olysio
• Active substance:
  simeprevir
• International non-proprietary name (INN) or common name:
  simeprevir
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AE14

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002777
• Marketing authorisation holder:
  Janssen-Cilag International NV

  Turnhoutseweg 30; B-2340 Beerse; Belgium

• Opinion adopted:
  20/03/2014
• Marketing authorisation issued:
  14/05/2014
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Olysio : EPAR - Procedural steps taken and scientific information after authorisation

Olysio-H-C-1438-A20-2777-0019 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/103226/2017

Olysio : EPAR - Scientific Conclusion

Olysio-EMEA-H-C-PSUSA-00010255-201411 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/484307/2015

Initial marketing authorisation documents

Olysio : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Olysio

AdoptedReference Number: EMA/CHMP/137969/2014