KALYDECO

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

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 more about Ivacaftor

Medication package inserts

Below package inserts are available for further reading:

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