EMEA-000019-PIP08-12-M03 - paediatric investigation plan

everolimus

Key facts

• Invented name:
  Votubia
• Active Substance:
  everolimus
• Therapeutic area:
  Neurology
• Decision number:
  P/0316/2017
• PIP number:
  EMEA-000019-PIP08-12-M03
• Pharmaceutical form(s):
  • Tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of tuberous sclerosis complex
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/10/2017
• Compliance procedure number:
  EMEA-C-000019-PIP08-12-M03
• Compliance opinion date:
  01/06/2018
• Compliance outcome:
  Positive

Decision

P/0316/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP08-12-M03)

Reference Number: EMA/666624/2017