EMEA-003272-PIP01-22 - paediatric investigation plan

tigulixostat

Key facts

• Active substance:
  tigulixostat
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0511/2022
• PIP number:
  EMEA-003272-PIP01-22
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hyperuricemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2022
• Compliance check done:
  No

Decision

P/0511/2022: EMA decision of 2 December 2023 on the granting of a product specific waiver for tigulixostat (EMEA-003272-PIP01-22)

Adopted Reference Number: EMA/898522/2022