EMA/PE/0000226303 - paediatric investigation plan

naldemedine tosilate

Key facts

• Invented name:
  Rizmoic
• Active substance:
  naldemedine tosilate
• Therapeutic area:
  Gastrointestinal disorders
• Decision number:
  EMA/PE/0000226303
• PIP number:
  EMA/PE/0000226303
• Pharmaceutical form(s):
  • Tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of opioid-induced constipation (OIC)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Όχι

Decision

EMA/PE/0000226303 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for naldemedine tosilate (Rizmoic)

Adopted Reference Number: EMADOC-1700519818-1855380