KAFTRIO

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

Active ingredients

The drug KAFTRIO contains a combination of these active pharmaceutical ingredients (APIs):

1 Ivacaftor UNII 1Y740ILL1Z - IVACAFTOR

Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations with reduced channel-open probability compared to normal CFTR. Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance). Read about Ivacaftor

2 Tezacaftor UNII 8RW88Y506K - TEZACAFTOR

3 Elexacaftor UNII RRN67GMB0V - ELEXACAFTOR

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KAFTRIO Granules	European Medicines Agency (EU)	MPI, EU: SmPC
KAFTRIO Film-coated tablet	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
R07AX32	Ivacaftor, tezacaftor and elexacaftor	R Respiratory system → R07 Other respiratory system products → R07A Other respiratory system products → R07AX Other respiratory system products
Discover more medicines within R07AX32

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): 1826232, 1872211
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 501123
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 389128
Country: IE	Health Products Regulatory Authority	Identifier(s): 89031
Country: IT	Agenzia del Farmaco	Identifier(s): 048984013, 048984025, 048984037, 048984049
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1091013
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100440279, 100464142
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67255001, W68420001