EMEA-000019-PIP06-09-M05 - paediatric investigation plan

everolimus

Key facts

• Invented name:
  • • Certican
    • Afinitor and associated names
  • Afinitor
• Active substance:
  everolimus
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0105/2014
• PIP number:
  EMEA-000019-PIP06-09-M05
• Pharmaceutical form(s):
  • Tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  • Prevention of rejection of transplanted liver
  • Prevention of rejection of transplanted heart
  • Prevention of rejection of transplanted kidney
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/05/2014
• Compliance check done:
  Nem

Decision

P/0105/2014: EMA decision of 5 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Afinitor, Certican and associated names) (EMEA-000019-PIP06-09-M05)

Adopted Reference Number: EMA/169119/2014