EMEA-003369-PIP01-22 - paediatric investigation plan

Utreloxastat

Key facts

• Active Substance:
  Utreloxastat
• Therapeutic area:
  Neurology
• Decision number:
  P/0129/2023
• PIP number:
  EMEA-003369-PIP01-22
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  PTC Therapeutics International Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/04/2023

Decision

P/0129/2023 : EMA decision of 13 April 2023 on the granting of a product specific waiver for utreloxastat (EMEA-003369-PIP01-22)

Reference Number: EMA/146791/2023