Zynteglo

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betibeglogene autotemcel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zynteglo has been withdrawn at the request of the marketing-authorisation holder.

 

This EPAR was last updated on 30/11/2022

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 assessmentAccelerated 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 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.

Conditional approvalConditional 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
3521 AZ Utrecht
The Netherlands

Product information

09/12/2021 Zynteglo - EMEA/H/C/003691 - N/0030

Other EU languages available icon 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:

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.

Assessment history

Changes since initial authorisation of medicine

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