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 more about Betibeglogene autotemcel

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
EE	Ravimiamet	1797936
FR	Base de données publique des médicaments	68847920
IT	Agenzia del Farmaco	047906019
LT	Valstybinė vaistų kontrolės tarnyba	1087928
PL	Rejestru Produktów Leczniczych	100421508