EMEA-001198-PIP04-23 - paediatric investigation plan

netupitant

Palonosetron

Key facts

• Invented name:
  Akynzeo
• Active substance:
  • netupitant
  • Palonosetron
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  P/0132/2024
• PIP number:
  EMEA-001198-PIP04-23
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Prevention of chemotherapy-induced nausea and vomiting
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/12/2024
• Compliance check done:
  No

Decision

P/0132/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for netupitant / palonosetron (Akynzeo) (EMEA-001198- PIP04-23)

Adopted Reference Number: EMA/105459/2024