KAFTRIO

This brand name is authorized in Austria, Estonia, Finland, Ireland, 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 Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC
KAFTRIO Granules 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: 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

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.