This brand name is authorized in Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States
The drug ORKAMBI contains a combination of these active pharmaceutical ingredients (APIs):
1
Lumacaftor
UNII EGP8L81APK - LUMACAFTOR
|
|
2
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 | |
---|---|---|---|
ORKAMBI Granules | European Medicines Agency (EU) | MPI, EU: SmPC | |
ORKAMBI 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 |
---|---|---|
R07AX30 | Ivacaftor and lumacaftor | 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): 11463H, 11464J, 11465K, 11466L, 11841F, 11848N, 11851R, 11866M |
Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 575019010000001, 575019010000101 |
Country: CA | Health Products and Food Branch | Identifier(s): 02451379, 02463040, 02483831, 02483858 |
Country: EE | Ravimiamet | Identifier(s): 1705070, 1736029, 1736030, 1762398, 1787496, 1787508 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1151059001, 1151059005 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 026127, 083886, 173267, 418179 |
Country: FR | Base de données publique des médicaments | Identifier(s): 61962699, 65639871, 66209488, 66352529 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 315527, 366273, 369202, 369205 |
Country: IE | Health Products Regulatory Authority | Identifier(s): 88791, 88843, 88844, 88889 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 7984, 8455 |
Country: IT | Agenzia del Farmaco | Identifier(s): 044560011, 044560023, 044560035, 044560047, 044560050, 044560062, 044560074 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1079119, 1081228, 1081229, 1084780, 1087019, 1087020 |
Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 129488, 149349, 197432, 197440 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100359130, 100418274, 100418280, 100428278 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W65261001, W65261003, W65262001, W67227001, W67228001 |
Country: US | FDA, National Drug Code | Identifier(s): 51167-500, 51167-700, 51167-809, 51167-900 |
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