EMEA-001198-PIP02-16 - paediatric investigation plan

Fosnetupitant

palonosetron

Key facts

• Invented name:
  • Akynzeo
  • Akynzeo
• Active substance:
  • Fosnetupitant
  • palonosetron
• Therapeutic area:
  Other
• Decision number:
  P/0358/2016
• PIP number:
  EMEA-001198-PIP02-16
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Prevention of chemotherapy-induced nausea and vomiting
• Route(s) of administration:
  Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  21/12/2016
• Compliance check done:
  No

Decision

P/0358/2016: EMA decision of 21 December 2016 on the refusal of a product specific waiver for fosnetupitant / palonosetron (Akynzeo), (EMEA-001198- PIP02-16)

Adopted Reference Number: EMA/791414/2016