EMEA-000709-PIP01-09-M05 - paediatric investigation plan

rufinamide

Key facts

• Invented name:
  • Inovelon
  • Inovelon
• Active substance:
  rufinamide
• Therapeutic area:
  Neurology
• Decision number:
  P/0116/2016
• PIP number:
  EMEA-000709-PIP01-09-M05
• Pharmaceutical form(s):
  • Tablet
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of Lennox-Gastaut syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2016
• Compliance check done:
  Ano
• Compliance procedure number:
  EMEA-C-000709-PIP01-09-M05
• Compliance opinion date:
  16/09/2016
• Compliance outcome:
  Positive

Decision

P/0116/2016: EMA decision of 22 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rufinamide (Inovelon), (EMEA-000709-PIP01-09-M05)

Adopted Reference Number: EMA/249393/2016