EMEA-002572-PIP01-19 - paediatric investigation plan

soticlestat

Key facts

• Active substance:
  soticlestat
• Therapeutic area:
  Neurology
• Decision number:
  P/0115/2020
• PIP number:
  EMEA-002572-PIP01-19
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  • Treatment of Chromosome 15q Duplication Syndrome
  • Treatment of Cyclin-Dependent Kinase-Like 5 deficiency disorder
• 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:
  18/03/2020
• Compliance check done:
  No

Decision

P/0115/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for soticlestat (EMEA-002572-PIP01-19)

Adopted Reference Number: EMA/76623/2020