EMEA-001440-PIP01-13-M03 - paediatric investigation plan

ombitasvir

paritaprevir

ritonavir

Key facts

• Invented name:
  • Viekirax
  • Viekirax
• Active substance:
  • ombitasvir
  • paritaprevir
  • ritonavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0288/2020
• PIP number:
  EMEA-001440-PIP01-13-M03
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2020
• Compliance check done:
  Non

Decision

P/0288/2020: EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ombitasvir / paritaprevir / ritonavir (Viekirax), (EMEA-001440-PIP01-13-M03)

Adopted Reference Number: EMA/388709/2020