EMEA-003462-PIP01-23 - paediatric investigation plan

Radiprodil

Key facts

• Active Substance:
  Radiprodil
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0197/2024
• PIP number:
  EMEA-003462-PIP01-23
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of GRIN-related disorder
• Route(s) of administration:
  • Oral use
  • Naso-gastric use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/06/2024

Decision

P/0197/2024: EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for radiprodil (EMEA-003462-PIP01-23)

AdoptedReference Number: EMA/257454/2024