EMEA-000293-PIP02-10-M01 - paediatric investigation plan

pegloticase

Key facts

• Invented name:
  • Krystexxa
  • Krystexxa
• Active substance:
  pegloticase
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0255/2013
• PIP number:
  EMEA-000293-PIP02-10-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Prevention of hyperuricaemia
  • Treatment of hyperuricaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2013
• Compliance check done:
  Não

Decision

P/0255/2013: EMA decision of 29 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for pegloticase (Krystexxa) (EMEA-000293-PIP02-10-M01)

Adopted Reference Number: EMA/589182/2013