Basic Information
Strimvelis
Regulatory Information
EMEA/H/C/003854
May 26, 2016
March 31, 2016
11
April 5, 2024
Company Information
Italy
Via Varese 16/B 00185 Rome
FONDAZIONE TELETHON ETS
Drug Classification
Active Substances Detail
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
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available (see section 4.2 and section 4.4).
Overview Summary
This is a summary of the European public assessment report (EPAR) for Strimvelis. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Strimvelis. For practical information about using Strimvelis, patients should read the package leaflet or contact their doctor or pharmacist.