EMEA-002572-PIP02-19-M05 - paediatric investigation plan
Soticlestat
PIPHuman
Key facts
- Active Substance
- Soticlestat
- Therapeutic area
- Nervous system disorders
- Decision number
- P/0194/2024
- PIP number
- EMEA-002572-PIP02-19-M05
- Pharmaceutical form(s)
- Film-coated tablet
- Age appropriate oral formulation
- Condition(s) / indication(s)
- Treatment of Dravet syndrome
- Treatment of Lennox-Gastaut syndrome
- Route(s) of administration
- Oral use
- Gastric use
- Intestinal use
- Contact for public enquiries
Takeda Pharma A/S
Tel. +44 (0)3333000181
E-mail: medinfoEMEA@takeda.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date