EMEA-002853-PIP01-20 - paediatric investigation plan

Viltolarsen

Key facts

• Active Substance:
  Viltolarsen
• Therapeutic area:
  Neurology
• Decision number:
  P/0083/2022
• PIP number:
  EMEA-002853-PIP01-20
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  NS Pharma, 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:
  11/03/2022

Decision

P/0083/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for viltolarsen (EMEA-002853-PIP01-20)

AdoptedReference Number: EMA/99042/2022