EMEA-001832-PIP01-15-M02 - paediatric investigation plan

glecaprevir

pibrentasvir

Key facts

• Invented name:
  Maviret
• Active Substance:
  • glecaprevir
  • pibrentasvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0128/2019
• PIP number:
  EMEA-001832-PIP01-15-M02
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019
• Compliance procedure number:
  EMEA-C-001832-PIP01-15-M02
• Compliance opinion date:
  11/12/2019
• Compliance outcome:
  Positive

Decision

P/0128/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for glecaprevir / pibrentasvir (Maviret) (EMEA-001832-PIP01-15-M02)

AdoptedReference Number: EMA/190118/2019