EMEA-001893-PIP01-15-M02 - paediatric investigation plan

Naldemedine

Key facts

• Active Substance:
  Naldemedine
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0379/2021
• PIP number:
  EMEA-001893-PIP01-15-M02
• Pharmaceutical form(s):
  • Tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of opioid-induced constipation (OIC)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Shionogi Limited

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021

Decision

P/0379/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for naldemedine (EMEA-001893-PIP01-15-M02)

AdoptedReference Number: EMA/464452/2021