LIBMELDY

This brand name is authorized in Austria, Croatia, Estonia, France, Ireland, Italy, Lithuania.

Active ingredients

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

1	Atidarsagene autotemcel UNII EPP8G99QG4 - ATIDARSAGENE AUTOTEMCEL
	Atidarsagene autotemcel is an ex vivo genetically modified autologous CD34+ hematopoietic stem and progenitor cell (HSPC) gene therapy. Autologous CD34+ HSPCs are collected from patient bone marrow (BM) harvest or from mobilised peripheral blood (mPB) and transduced with a lentiviral vector (ARSA LVV), which inserts one or more copies of the human ARSA complementary deoxyribonucleic acid (cDNA) into the cell’s genome, so that genetically modified cells become capable of expressing the functional ARSA enzyme.
	Read more about Atidarsagene autotemcel

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
LIBMELDY 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
A16AB21		A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AB Enzymes
Discover more medicines within A16AB21

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	1837672
FR	Base de données publique des médicaments	63621440
IT	Agenzia del Farmaco	049239015
LT	Valstybinė vaistų kontrolės tarnyba	1091698