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
• Contact for public enquiries:

  Aimmune Therapeutics Inc

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/03/2023

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)

AdoptedReference Number: EMA/130959/2023