EMEA-001597-PIP01-13 - paediatric investigation plan

lesinurad

Key facts

• Active Substance:
  lesinurad
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0153/2014
• PIP number:
  EMEA-001597-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Prevention of hyperuricaemia
  • Treatment of hyperuricaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AstraZeneca AB - Astrazeneca European Regulatory Affairs

  Sweden; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/06/2014

Decision

P/0153/2014: EMA decision of 13 June 2014 on the granting of a product-specific waiver for lesinurad (EMEA-001597-PIP01-13)

AdoptedReference Number: EMA/268797/2014