EMEA-003171-PIP01-21 - paediatric investigation plan

Obecabtagene autoleucel

Key facts

• Active Substance:
  Obecabtagene autoleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0094/2023
• PIP number:
  EMEA-003171-PIP01-21
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of acute lymphoblastic leukaemia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Autolus GmbH

  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:
  10/03/2023

Decision

P/0094/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obecabtagene autoleucel (EMEA-003171-PIP01-21)

AdoptedReference Number: EMA/66808/2023