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
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). |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
KALYDECO Granules | European Medicines Agency (EU) | MPI, EU: SmPC | |
KALYDECO Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 | |
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 |
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