Symkevi

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tezacaftor / ivacaftor

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

Overview

Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above. Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs. Cystic fibrosis affects the cells that produce mucus and digestive juices. As a result, these secretions become thick and cause blockage. Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection. In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.

Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator’ (CFTR).

Symkevi is used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene. It is also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.

Symkevi contains the active substances tezacaftor and ivacaftor.

Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 February 2017. Further information on the orphan designation can be found on EU/3/17/1828.

This EPAR was last updated on 22/11/2018

Authorisation details

Product details
Name
Symkevi
Agency product number
EMEA/H/C/004682
Active substance
  • tezacaftor
  • ivacaftor
International non-proprietary name (INN) or common name
tezacaftor / ivacaftor
Therapeutic area (MeSH)
Cystic Fibrosis
Anatomical therapeutic chemical (ATC) code
R07AX31
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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Vertex Pharmaceuticals (Europe) Ltd.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
31/10/2018
Contact address
2 Kingdom Street London
W2 6BD
United Kingdom

Product information

31/10/2018 Symkevi - EMEA/H/C/004682 - -

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Pharmacotherapeutic group

OTHER RESPIRATORY SYSTEM PRODUCTS

Therapeutic indication

Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.

Assessment history

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