EMEA-003064-PIP01-21 - paediatric investigation plan

lademirsen

Key facts

• Active Substance:
  lademirsen
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0336/2022
• PIP number:
  EMEA-003064-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Alport syndrome
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Genzyme Europe B.V.

  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:
  10/08/2022

Decision

P/0336/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lademirsen (EMEA-003064-PIP01-21)

AdoptedReference Number: EMA/673785/2022