Orkambi

RSS

lumacaftor / ivacaftor

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

Overview

This is a summary of the European public assessment report (EPAR) for Orkambi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Orkambi.

For practical information about using Orkambi, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/10/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Vertex Pharmaceuticals (Europe) Ltd
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address
2 Kingdom Street
London W2 6BD
United Kingdom

Product information

23/08/2018 Orkambi - EMEA/H/C/003954 - PSUSA/00010455/201711

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER RESPIRATORY SYSTEM PRODUCTS

Therapeutic indication

Orkambi is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years 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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