EMEA-001198-PIP03-17-M05 - paediatric investigation plan

Fosnetupitant

Palonosetron

Key facts

• Invented name:
  Akynzeo
• Active substance:
  • Fosnetupitant
  • Palonosetron
• Therapeutic area:
  Other
• Decision number:
  P/0418/2023
• PIP number:
  EMEA-001198-PIP03-17-M05
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of chemotherapy-induced nausea and vomiting
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2023
• Compliance check done:
  No

Decision

P/0418/2023 : EMA decision of 25 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fosnetupitant / palonosetron (Akynzeo), (EMEA-001198-PIP03-17-M05)

Adopted Reference Number: EMA/469388/2023