Zynteglo
betibeglogene autotemcel
Table of contents
Overview
The marketing authorisation for Zynteglo has been withdrawn at the request of the marketing-authorisation holder.
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Zynteglo : EPAR - Medicine overview (PDF/649.46 KB)
First published: 03/06/2019
EMA/205979/2019 -
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Zynteglo : EPAR - Risk-management-plan summary (PDF/220.91 KB)
First published: 03/06/2019
Last updated: 04/10/2021
Authorisation details
| Product details | |
|---|---|
| Name |
Zynteglo
|
| Agency product number |
EMEA/H/C/003691
|
| Active substance |
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene
|
| International non-proprietary name (INN) or common name |
betibeglogene autotemcel
|
| Therapeutic area (MeSH) |
beta-Thalassemia
|
| Anatomical therapeutic chemical (ATC) code |
B06A
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
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. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
bluebird bio (Netherlands) B.V.
|
| Revision |
5
|
| Date of issue of marketing authorisation valid throughout the European Union |
29/05/2019
|
| Contact address |
Stadsplateau 7 |
Product information
09/12/2021 Zynteglo - EMEA/H/C/003691 - N/0030
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Other hematological agents
Therapeutic indication
Zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β thalassaemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available.