EMEA-003618-PIP01-24 - paediatric investigation plan

2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione

Key facts

• Active substance:
  2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0002/2025
• PIP number:
  EMEA-003618-PIP01-24
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of primary mitochondrial disorders
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/01/2025
• Compliance check done:
  Ei

Decision

P/0002/2025 : EMA decision of 28 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral for 2-isopropyl- 3H-naphtho[1,2-d]imidazole-4,5-dione (KL1333), (EMEA-003618-PIP01-24)

Adopted