EMEA-001792-PIP01-15 - paediatric investigation plan

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human Wiskott Aldrich Syndrome (WAS) cDNA sequence

Key facts

• Active substance:
  autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human Wiskott Aldrich Syndrome (WAS) cDNA sequence
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0083/2016
• PIP number:
  EMEA-001792-PIP01-15
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of Wiskott Aldrich Syndrome
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/03/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-001792-PIP01-15
• Compliance opinion date:
  24/03/2017
• Compliance outcome:
  Positive

Decision

P/0083/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan for autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the ...

Adopted Reference Number: EMA/107868/2016