EMEA-001094-PIP01-10-M04 - paediatric investigation plan

teriflunomide

Key facts

• Invented name:
  • Aubagio
  • Aubagio
• Active substance:
  teriflunomide
• Therapeutic area:
  Neurology
• Decision number:
  P/0165/2017
• PIP number:
  EMEA-001094-PIP01-10-M04
• Pharmaceutical form(s):
  Film-coated tablet
• 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:
  03/07/2017
• Compliance check done:
  Kyllä
• Compliance procedure number:
  EMEA-C-001094-PIP01-10-M04
• Compliance opinion date:
  23/06/2023
• Compliance outcome:
  Positive

Decision

P/0165/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for teriflunomide (Aubagio), (EMEA-001094-PIP01-10-M04)

Adopted Reference Number: EMA/354119/2017