EMEA-003075-PIP01-21 - paediatric investigation plan

Censavudine

Key facts

• Active Substance:
  Censavudine
• Therapeutic area:
  Neurology
• Decision number:
  P/0103/2022
• PIP number:
  EMEA-003075-PIP01-21
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Age-appropriate oral suspension formulation
• Condition(s) / indication(s):
  Treatment of Aicardi-Goutières syndrome
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Transposon Therapeutics, Inc.

  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:
  21/03/2022

Decision

P/0103/2022 : EMA decision of 21 March 2022 on the agreement of a paediatric investigation plan for censavudine (EMEA-003075-PIP01-21)

AdoptedReference Number: EMA/149068/2022