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Assessment Report (EPAR) for Olysio is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
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.
Therapeutic Area (MeSH)
ATC Code
J05AE14
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
EMA Name
Olysio
Medicine Name
Olysio
Aliases
N/ANo risk management plan link.