EMEA-003416-PIP01-23 - paediatric investigation plan

irinotecan

Key facts

• Invented name:
  onivyde
• Active substance:
  irinotecan
• Therapeutic area:
  Oncology
• Decision number:
  P/0241/2023
• PIP number:
  EMEA-003416-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of pancreatic cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023
• Compliance check done:
  Ei

Decision

P/0241/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for irinotecan (Onivyde), (EMEA-003416-PIP01-23)

Reference Number: EMA/241942/2023