EMEA-001952-PIP01-16 - paediatric investigation plan

lesinurad

allopurinol

Key facts

• Active Substance:
  • lesinurad
  • allopurinol
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0239/2016
• PIP number:
  EMEA-001952-PIP01-16
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hyperuricaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AstraZeneca AB (Germany)

  Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2016

Decision

P/0239/2016: EMA decision of 9 September 2016 on the granting of a product specific waiver for lesinurad / allopurinol, (EMEA-001952-PIP01-16)

AdoptedReference Number: EMA/580049/2016