EMEA-000625-PIP01-09-M03

Key facts

Invented name
Olysio
Active substance
simeprevir
Therapeutic area
Infectious diseases
Decision number
P/0325/2018
PIP number
EMEA-000625-PIP01-09-M03
Pharmaceutical form(s)
  • Capsule hard
  • Age-appropriate formulation
Condition(s) / indication(s)
Treatment of chronic viral hepatitis C
Route(s) of administration
Oral use
Contact for public enquiries
Janssen-Cilag International NV

E-mail: contact@janssen-emea.com
Tel. +32 1460 2111

Decision type
W: decision granting a waiver in all age groups for all conditions/indications

Decision

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