EMEA-003593-PIP01-24 - paediatric investigation plan

autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene

Key facts

• Active Substance:
  autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0233/2024
• PIP number:
  EMEA-003593-PIP01-24
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of systemic light chain amyloidosis
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/07/2024

Decision

P/0233/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene (EMEA-003593-PIP01-24)

AdoptedReference Number: EMA/321024/2024