ORKAMBI

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

Active ingredients

The drug ORKAMBI contains a combination of these active pharmaceutical ingredients (APIs):

1 Lumacaftor UNII EGP8L81APK - LUMACAFTOR

Read about 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). Read about Ivacaftor

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ORKAMBI Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
ORKAMBI 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
R07AX30	Ivacaftor and lumacaftor	R Respiratory system → R07 Other respiratory system products → R07A Other respiratory system products → R07AX Other respiratory system products
Discover more medicines within R07AX30

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): 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