EMEA-001933-PIP01-16-M01 - paediatric investigation plan

autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene

Key facts

• Active substance:
  autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0236/2020
• PIP number:
  EMEA-001933-PIP01-16-M01
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of beta-thalassemia
• Route(s) of administration:
  Intraosseous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/06/2020
• Compliance check done:
  No

Decision

P/0236/2020: European Medicines Agency decision of 12 June 2020 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene (EMEA-001933(.)

Adopted Reference Number: EMA/305826/2020