EMEA-001146-PIP01-11-M07 - paediatric investigation plan

naloxegol

Key facts

• Invented name:
  Moventig
• Active substance:
  naloxegol
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0493/2021
• PIP number:
  EMEA-001146-PIP01-11-M07
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of opioid-induced constipation
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001146-PIP01-11-M07
• Compliance opinion date:
  11/11/2022
• Compliance outcome:
  Positive

Decision

P/0493/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for naloxegol (Moventig), (EMEA-001146-PIP01-11-M07)

Adopted Reference Number: EMA/616446/2021