EMEA-000087-PIP01-07-M05 - paediatric investigation plan

fingolimod hydrochloride 

Key facts

• Invented name:
  • Gilenya
  • Gilenya
• Active substance:
  fingolimod hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0050/2017
• PIP number:
  EMEA-000087-PIP01-07-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:
  03/04/2017
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000087-PIP01-07-M05
• Compliance opinion date:
  10/11/2017
• Compliance outcome:
  Positive

Decision

P/0050/2017: EMA decision of 3 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for fingolimod (hydrochloride), (Gilenya) (EMEA-000087-PIP01-07-M05)

Adopted Reference Number: EMA/120501/2017