EMEA-002876-PIP02-23 - paediatric investigation plan

sodium phenylbutyrate / ursodoxicoltaurine

Key facts

• Active substance:
  sodium phenylbutyrate / ursodoxicoltaurine
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0087/2024
• PIP number:
  EMEA-002876-PIP02-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of progressive supranuclear palsy
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/03/2024
• Compliance check done:
  No

Decision

P/0087/2024: EMA decision of 20 March 2024 on the granting of a product specific waiver for sodium phenylbutyrate / ursodoxicoltaurine (EMEA-002876-PIP02-23)

Adopted Reference Number: EMA/114329/2024