EMEA-000832-PIP01-10-M05 - paediatric investigation plan

dimethyl fumarate

Key facts

• Invented name:
  Tecfidera
• Active substance:
  dimethyl fumarate
• Therapeutic area:
  Neurology
• Decision number:
  P/0177/2020
• PIP number:
  EMEA-000832-PIP01-10-M05
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2020
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000832-PIP01-10-M05
• Compliance opinion date:
  14/06/2021
• Compliance outcome:
  Positive

Decision

P/0177/2020: EMA decision of 15 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for dimethyl fumarate (Tecfidera), (EMEA-000832-PIP01-10-M05)

Adopted Reference Number: EMA/178693/2020