Strimvelis - direct healthcare professional communication (DHPC)

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells

About

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

Documents

Direct healthcare professional communication (DHPC): Strimvelis: first case of lymphoid T cell leukaemia after insertional oncogenesis

Key facts

• Medicine name:
  Strimvelis
• Active substance:
  autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells
• Therapeutic area (MeSH):
  Severe Combined Immunodeficiency
• Procedure number:
  EMEA/H/C/003854/R/0029
• Regulatory outcome:
  Maintenance
• DHPC type:
  Adverse event
• Human ATC codes:
  L03
• Dissemination date:
  22/03/2021