EMEA-001289-PIP01-12-M01 - paediatric investigation plan

autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA

Key facts

• Invented name:
  Strimvelis
• Active substance:
  autologous CD34+ cells transduced ex-vivo with retroviral vector (GIADAl) containing human adenosine deaminase gene from cDNA
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0190/2014
• PIP number:
  EMEA-001289-PIP01-12-M01
• Pharmaceutical form(s):
  Cell suspension for infusion
• Condition(s) / indication(s):
  Treatment of severe combined immunodeficiency due to adenosine deaminase deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/08/2014
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001289-PIP01-12-M01
• Compliance opinion date:
  14/11/2014
• Compliance outcome:
  Positive

Decision

P/0190/2014: EMA decision of 6 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ Cells Transduced ex-vivo with Retroviral Vector (GIADAl) Containing Human Ade...

Adopted Reference Number: EMA/391460/2014