EMA/PE/0000236274 - paediatric investigation plan

lacosamide

Key facts

• Invented name:
  Vimpat
• Active substance:
  lacosamide
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000236274
• PIP number:
  EMA/PE/0000236274
• Pharmaceutical form(s):
  • Film-coated tablet
  • Solution for infusion
  • Syrup
• Condition(s) / indication(s):
  Treatment of generalised epilepsy and epileptic syndromes
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/04/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000236274 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat)

Adopted Reference Number: EMADOC-1700519818-2022822