EMEA-001734-PIP01-14-M06 - paediatric investigation plan

defatted powder of Arachis hypogaea L., semen (peanuts)

Key facts

• Invented name:
  Palforzia
• Active substance:
  defatted powder of Arachis hypogaea L., semen (peanuts)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0103/2023
• PIP number:
  EMEA-001734-PIP01-14-M06
• Pharmaceutical form(s):
  • Oral powder
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of peanut allergy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/03/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001734-PIP01-14-M06
• Compliance opinion date:
  23/06/2023
• Compliance outcome:
  Positive

Decision

P/0103/2023 : EMA decision of 24 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for defatted powder of peanuts (PALFORZIA), (EMEA-001734-PIP01-14-M06)

Adopted Reference Number: EMA/130959/2023