ORKAMBI

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, Poland, Romania, Spain, UK.

Active ingredients

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

1	Lumacaftor UNII EGP8L81APK - LUMACAFTOR
	Read more 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 more about Ivacaftor

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ORKAMBI Granules	MPI, EU: SmPC	European Medicines Agency (EU)
ORKAMBI 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
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)
AU	Pharmaceutical Benefits Scheme	11463H, 11464J, 11465K, 11466L, 11841F, 11848N, 11851R, 11866M
BR	Câmara de Regulação do Mercado de Medicamentos	575019010000001, 575019010000101
CA	Health Products and Food Branch	02451379, 02463040, 02483831, 02483858
EE	Ravimiamet	1705070, 1736029, 1736030, 1762398, 1787496, 1787508
ES	Centro de información online de medicamentos de la AEMPS	1151059001, 1151059005
FI	Lääkealan turvallisuus- ja kehittämiskeskus	026127, 083886, 173267, 418179
FR	Base de données publique des médicaments	61962699, 65639871, 66209488, 66352529
GB	Medicines & Healthcare Products Regulatory Agency	315527, 366273, 369202, 369205
IE	Health Products Regulatory Authority	88791, 88843, 88844, 88889
IL	מִשְׂרַד הַבְּרִיאוּת	7984, 8455
IT	Agenzia del Farmaco	044560011, 044560023, 044560035, 044560047, 044560050, 044560062, 044560074
LT	Valstybinė vaistų kontrolės tarnyba	1079119, 1081228, 1081229, 1084780, 1087019, 1087020
NL	Z-Index G-Standaard, PRK	129488, 149349, 197432, 197440
PL	Rejestru Produktów Leczniczych	100359130, 100418274, 100418280, 100428278
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65261001, W65261003, W65262001, W67227001, W67228001
US	FDA, National Drug Code	51167-500, 51167-700, 51167-809, 51167-900