KALYDECO

This brand name is authorized in Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States

Active ingredients

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

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

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KALYDECO Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
KALYDECO 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
R07AX02		R Respiratory system → R07 Other respiratory system products → R07A Other respiratory system products → R07AX Other respiratory system products
Discover more medicines within R07AX02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10170G, 10175M, 11097C, 11098D, 11105L, 11109Q
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 575019010000201
Country: CA	Health Products and Food Branch	Identifier(s): 02397412, 02442612, 02442620
Country: EE	Ravimiamet	Identifier(s): 1590128, 1704125, 1704136, 1809198, 1821057, 1834523, 1834534
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 112782002, 112782003, 112782004
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 393242
Country: FR	Base de données publique des médicaments	Identifier(s): 65036318, 65261329, 66701315, 68381052
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 211782, 315535, 315540, 367411, 380869, 392000
Country: IE	Health Products Regulatory Authority	Identifier(s): 88134, 88797, 88799, 88846, 89010, 89042
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7599, 8367, 8669
Country: IT	Agenzia del Farmaco	Identifier(s): 043519014, 043519026, 043519038, 043519040, 043519053, 043519065, 043519077, 043519089
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1067103, 1067104, 1079265, 1079266, 1086536, 1089055, 1091498
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 115134, 129747, 129755, 201383
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16074, 21524, 21525
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100311211, 100387208, 100387214, 100443326, 100446885
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65612001, W65612002, W65612003, W65613001, W65614001, W67226001, W67343001
Country: US	FDA, National Drug Code	Identifier(s): 51167-200, 51167-300, 51167-400, 51167-600