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 05/09/2018

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 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
Marketing-authorisation holder
Orchard Therapeutics (Netherlands) BV
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
26/05/2016
Contact address
Prins Bernhardplein 200
1097 JB Amsterdam
The Netherlands

Product information

23/08/2018 Strimvelis - EMEA/H/C/003854 - T/0014

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).

Assessment history

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