TIBSOVO

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Cyprus, Estonia, Finland, France, Ireland, Italy, Lithuania, Romania, UK.

Active ingredients

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

1	Ivosidenib UNII Q2PCN8MAM6 - IVOSIDENIB
	Ivosidenib is an inhibitor of the mutant IDH1 enzyme. Mutant IDH1 converts alpha- ketoglutarate (αKG) to 2-hydroxyglutarate (2-HG) which blocks cellular differentiation and promotes tumorigenesis in both hematologic and non-hematologic malignancies. The mechanism of action of ivosidenib beyond its ability to reduce 2-HG and restore cellular differentiation is not fully understood across indications.
	Read more about Ivosidenib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TIBSOVO Film-coated tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)
TIBSOVO Film-coated tablet	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
L01XM02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XM Isocitrate dehydrogenase (IDH) inhibitors
Discover more medicines within L01XM02

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	3036923
FI	Lääkealan turvallisuus- ja kehittämiskeskus	135124
FR	Base de données publique des médicaments	63239234
IT	Agenzia del Farmaco	050710019
LT	Valstybinė vaistų kontrolės tarnyba	1097094
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W69798001
US	FDA, National Drug Code	71334-100