EMEA-001417-PIP01-12-M04 - paediatric investigation plan

febuxostat

Key facts

• Invented name:
  • Adenuric
  • Adenuric
• Active substance:
  febuxostat
• Therapeutic area:
  Oncology
• Decision number:
  P/0226/2018
• PIP number:
  EMEA-001417-PIP01-12-M04
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of hyperuricaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/07/2018
• Compliance check done:
  Nem

Decision

P/0226/2018: EMA decision of 20 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for febuxostat (Adenuric), (EMEA-001417-PIP01-12-M04)

Adopted Reference Number: EMA/471696/2018