🇪🇺 BETIBEGLOGENE AUTOTEMCEL in European Union

EMA authorised BETIBEGLOGENE AUTOTEMCEL on 29 May 2019

Marketing authorisation

EMA — authorised 29 May 2019

  • Application: EMEA/H/C/003691
  • Marketing authorisation holder: bluebird bio (Netherlands) B.V.
  • Local brand name: Zynteglo
  • 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.  
  • Pathway: accelerated assessment, conditional, ATMP, PRIME
  • Status: withdrawn

Read official source →

BETIBEGLOGENE AUTOTEMCEL in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is BETIBEGLOGENE AUTOTEMCEL approved in European Union?

Yes. EMA authorised it on 29 May 2019.

Who is the marketing authorisation holder for BETIBEGLOGENE AUTOTEMCEL in European Union?

bluebird bio (Netherlands) B.V. holds the EU marketing authorisation.