ZYNTEGLO

This brand name is authorized in Austria, Cyprus, Estonia, France, Ireland, Italy, Lithuania, Poland

Active ingredients

The drug ZYNTEGLO contains one active pharmaceutical ingredient (API):

1 Betibeglogene autotemcel UNII MEE8487RTP - BETIBEGLOGENE AUTOTEMCEL

Betibeglogene autotemcel adds functional copies of a modified β-globin gene into the patients' HSCs through transduction of autologous CD34+ cells with BB305 LVV, thereby addressing the underlying genetic cause of the disease. After betibeglogene autotemcel infusion, transduced CD34+ HSCs engraft in the bone marrow and differentiate to produce RBCs containing biologically active βA-T87Q-globin (a modified β-globin protein) that will combine with α-globin to produce functional Hb containing βA-T87Q-globin (HbAT87Q). Read about Betibeglogene autotemcel

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ZYNTEGLO Dispersion for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
B06AX02		B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AX Other hematological agents
Discover more medicines within B06AX02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1797936
Country: FR	Base de données publique des médicaments	Identifier(s): 68847920
Country: IT	Agenzia del Farmaco	Identifier(s): 047906019
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1087928
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100421508