Strimvelis

RSS

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 01/08/2022

Authorisation details

Product details
Name
Strimvelis
Agency product number
EMEA/H/C/003854
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
Therapeutic area (MeSH)
Severe Combined Immunodeficiency
Anatomical therapeutic chemical (ATC) code
L03
Additional monitoringAdditional 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.

OrphanOrphan

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
Marketing-authorisation holder
Orchard Therapeutics (Netherlands) BV
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
26/05/2016
Contact address

Orchard Therapeutics (Netherlands) BV

Basisweg 10
1043 AP
Amsterdam
The Netherlands

Product information

21/07/2022 Strimvelis - EMEA/H/C/003854 - II-33

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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