KAFTRIO

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

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 more about Ivacaftor
2	Tezacaftor UNII 8RW88Y506K - TEZACAFTOR
3	Elexacaftor UNII RRN67GMB0V - ELEXACAFTOR

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KAFTRIO Granules	MPI, EU: SmPC	European Medicines Agency (EU)
KAFTRIO 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
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)
EE	Ravimiamet	1826232, 1872211
FI	Lääkealan turvallisuus- ja kehittämiskeskus	501123
GB	Medicines & Healthcare Products Regulatory Agency	389128
IE	Health Products Regulatory Authority	89031
IT	Agenzia del Farmaco	048984013, 048984025, 048984037, 048984049
LT	Valstybinė vaistų kontrolės tarnyba	1091013
PL	Rejestru Produktów Leczniczych	100440279, 100464142
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67255001, W68420001