EMEA-000402-PIP03-17-M08 - paediatric investigation plan

lacosamide

Key facts

• Invented name:
  Vimpat
• Active substance:
  lacosamide
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0470/2023
• PIP number:
  EMEA-000402-PIP03-17-M08
• 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:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0470/2023 : EMA decision of of 1 December 2023 on the refusal of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat), (EMEA-000402-PIP03-17-M08)

Adopted Reference Number: EMA/512497/2023