EMEA-000144-PIP01-07-M05 - paediatric investigation plan

aprepitant

Key facts

• Invented name:
  • Emend
  • Emend
• Active substance:
  aprepitant
• Therapeutic area:
  Oncology
• Decision number:
  P/0008/2014
• PIP number:
  EMEA-000144-PIP01-07-M05
• Pharmaceutical form(s):
  • Powder for suspension
  • Capsule, hard
• Condition(s) / indication(s):
  Prevention of nausea and vomiting
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/01/2014
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000144-PIP01-07-M05
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0008/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aprepitant (Emend) (EMEA-000144-PIP01-07-M05)

Adopted Reference Number: EMA/10425/2014