Orkambi

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lumacaftor / ivacaftor

Authorised
This medicine is authorised for use in the European Union.

Overview

Orkambi is a medicine used to treat cystic fibrosis in patients aged 1 year and above. Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system (gut) and other organs.

Orkambi is used in patients who have a genetic mutation (change) called the F508del mutation. This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR). Orkambi is used in patients who have inherited the mutation from both parents.

Orkambi contains the active substances lumacaftor and ivacaftor.

This EPAR was last updated on 27/07/2023

Authorisation details

Product details
Name
Orkambi
Agency product number
EMEA/H/C/003954
Active substance
  • Lumacaftor
  • ivacaftor
International non-proprietary name (INN) or common name
  • lumacaftor
  • ivacaftor
Therapeutic area (MeSH)
Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code
R07AX30
Publication details
Marketing-authorisation holder
Vertex Pharmaceuticals (Ireland) Limited
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address

Unit 49, Block F2, Northwood Court, Santry
Dublin 9, D09 T665
Ireland

Product information

04/07/2023 Orkambi - EMEA/H/C/003954 - X/0078/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other respiratory system products

Therapeutic indication

Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.

Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.

Assessment history

Changes since initial authorisation of medicine

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