Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
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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.
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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 code |
L03
|
| Dissemination date |
22/03/2021
|