EMEA-003200-PIP01-22 - paediatric investigation plan

stiripentol

Key facts

• Active Substance:
  stiripentol
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0520/2022
• PIP number:
  EMEA-003200-PIP01-22
• Pharmaceutical form(s):
  • Powder for oral suspension
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of primary hyperoxaluria
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Biocodex SA

  E-mail: [e-mail]

  Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  30/12/2022

Decision

P/0520/2022: EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for stiripentol (EMEA-003200-PIP01-22)

AdoptedReference Number: EMA/915926/2022