EMEA-000402-PIP02-11-M05 - paediatric investigation plan

lacosamide

Key facts

• Invented name:
  • Vimpat
  • Vimpat
• Active substance:
  lacosamide
• Therapeutic area:
  Neurology
• Decision number:
  P/0001/2018
• PIP number:
  EMEA-000402-PIP02-11-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Syrup
  • Solution for infusion
• Condition(s) / indication(s):
  Treatment of epilepsy with partial-onset seizures
• Route(s) of administration:
  • Oral use
  • Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/01/2018
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-000402-PIP02-11-M05
• Compliance opinion date:
  27/07/2018
• Compliance outcome:
  Positive

Decision

P/0001/2018: EMA decision of 8 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat) (EMEA-000402-PIP02-11-M05)

Reference Number: EMA/850455/2017