EMEA-003084-PIP03-22 - paediatric investigation plan

Troriluzole hydrochloride

Key facts

• Active Substance:
  Troriluzole hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0044/2023
• PIP number:
  EMEA-003084-PIP03-22
• Pharmaceutical form(s):
  • Age-appropriate oral dosage formulation
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of hereditary spinocerebellar ataxia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Biohaven Pharmaceutical Ireland DAC

  Email: [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:
  31/01/2023

Decision

P/0044/2023 : EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for troriluzole (hydrochloride) (EMEA-003084-PIP03-22)

Reference Number: EMA/34175/2023