EMEA-000019-PIP02-07-M05 - paediatric investigation plan

everolimus

Key facts

• Invented name:
  • Votubia
  • Votubia
• Active Substance:
  everolimus
• Therapeutic area:
  Neurology
• Decision number:
  P/0003/2014
• PIP number:
  EMEA-000019-PIP02-07-M05
• Pharmaceutical form(s):
  • Tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  • Treatment of angiomyolipoma
  • Treatment of subependymal giant-cell astrocytoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Ltd

  United Kingdom; E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/01/2014
• Compliance procedure number:
  EMEA-C-000019-PIP02-07-M05
• Compliance opinion date:
  29/01/2016
• Compliance outcome:
  Positive

Decision

P/0003/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05)

AdoptedReference Number: EMA/776286/2013