Orkambi
lumacaftor / ivacaftor
Table of contents
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.
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Orkambi : EPAR - Medicine overview (PDF/109.42 KB)
First published: 01/12/2015
Last updated: 27/07/2023 -
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Orkambi : EPAR - Risk-management-plan summary (PDF/2.69 MB)
First published: 01/12/2015
Last updated: 27/07/2023
Authorisation details
Product details | |
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Name |
Orkambi
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Agency product number |
EMEA/H/C/003954
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Cystic Fibrosis
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Anatomical therapeutic chemical (ATC) code |
R07AX30
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Publication details | |
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Marketing-authorisation holder |
Vertex Pharmaceuticals (Ireland) Limited
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Revision |
32
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
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Contact address |
Unit 49, Block F2, Northwood Court, Santry |
Product information
04/07/2023 Orkambi - EMEA/H/C/003954 - X/0078/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
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16/11/2018
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10/11/2017
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25/09/2015