EMEA-002490-PIP01-18 - paediatric investigation plan

Mavorixafor

Key facts

• Active Substance:
  Mavorixafor
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0185/2024
• PIP number:
  EMEA-002490-PIP01-18
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral liquid dosage formulation
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/05/2024

Decision

P/0185/2024: EMA decision of 23 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mavorixafor (EMEA-002490-PIP01-18)

AdoptedReference Number: EMA/243653/2024