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 Granules European Medicines Agency (EU) MPI, EU: SmPC
ORKAMBI Film-coated tablet 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

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