EMEA-001604-PIP01-13-M03 - paediatric investigation plan

grazoprevir

elbasvir

Key facts

• Invented name:
  • Zepatier
  • Zepatier
• Active substance:
  • grazoprevir
  • elbasvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0255/2017
• PIP number:
  EMEA-001604-PIP01-13-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/09/2017
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001604-PIP01-13-M03
• Compliance opinion date:
  11/12/2020
• Compliance outcome:
  Positive

Decision

P/0255/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for grazoprevir / elbasvir (Zepatier), (EMEA-001604-PIP01-13-M03)

Adopted Reference Number: EMA/501661/2017