TIBSOVO

This brand name is authorized in Austria, Cyprus, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom, United States

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 about Ivosidenib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TIBSOVO Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
TIBSOVO Film-coated tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
L01XX62		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XX Other antineoplastic agents
Discover more medicines within L01XX62

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