Strimvelis
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Table of contents
Overview
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.
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List item
Strimvelis : EPAR - Summary for the public (PDF/81.98 KB)
First published: 08/06/2016
Last updated: 08/06/2016 -
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List item
Strimvelis : EPAR - Risk-management-plan summary (PDF/279.11 KB)
First published: 11/06/2020
Authorisation details
Product details | |
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Name |
Strimvelis
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Agency product number |
EMEA/H/C/003854
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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
|
International non-proprietary name (INN) or common name |
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
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Therapeutic area (MeSH) |
Severe Combined Immunodeficiency
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Anatomical therapeutic chemical (ATC) code |
L03
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Orchard Therapeutics (Netherlands) BV
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Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
26/05/2016
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Contact address |
Product information
16/12/2020 Strimvelis - EMEA/H/C/003854 - IAIN/0030/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Immunostimulants
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).