Olysio

Withdrawn

This medicine's authorisation has been withdrawn

simeprevir

Overview

On 1 May 2018, the European Commission withdrew the marketing authorisation for Olysio (simeprevir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Janssen-Cilag International NV, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Olysio was granted marketing authorisation in the EU on 14 May 2014 for the treatment of chronic hepatitis C (CHC) in adult patients, in combination with other medicinal products. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Olysio is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Olysio : EPAR - Summary for the public

Olysio : EPAR - Risk-management-plan summary

Product information

Olysio : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  01/05/2018
• 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

Adopted Reference 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

Adopted Reference Number: EMA/CHMP/137969/2014