EMEA-000406-PIP01-08-M04 - paediatric investigation plan

fosaprepitant

Key facts

• Invented name:
  • Ivemend
  • Ivemend
• Active substance:
  fosaprepitant
• Therapeutic area:
  Oncology
• Decision number:
  P/0010/2014
• PIP number:
  EMEA-000406-PIP01-08-M04
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Prevention of nausea and vomiting
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/01/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000406-PIP01-08-M04
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0010/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for fosaprepitant (Ivemend) (EMEA-000406-PIP01-08-M04)

Adopted Reference Number: EMA/10721/2014