EMEA-000786-PIP01-09-M02 - paediatric investigation plan

Autologous CD34+ cells transduced with lentiviral vector containing the human Wiskott Aldrich Syndrom Protein gene

Key facts

• Active Substance:
  Autologous CD34+ cells transduced with lentiviral vector containing the human Wiskott Aldrich Syndrom Protein gene
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0260/2016
• PIP number:
  EMEA-000786-PIP01-09-M02
• Pharmaceutical form(s):
  Cell suspension for infusion
• Condition(s) / indication(s):
  Treatment of Wiskott Aldrich Syndrome
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Genethon

  France; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/10/2016

Decision

P/0260/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ cells transduced with lentiviral vector containing the human Wiskott Aldric...

AdoptedReference Number: EMA/585489/2016