Lyfnua
gefapixant
Table of contents
Overview
Lyfnua is a medicine used to treat adults with chronic (long-term) cough which is unexplained or for which other treatments have not worked.
The medicine contains the active substance gefapixant.
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List item
Lyfnua - EPAR - Medicine overview (PDF/98.47 KB)
First published: 29/09/2023
EMA/342744/2023 -
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List item
Lyfnua : EPAR - Risk management plan (PDF/380.77 KB)
First published: 29/09/2023
Authorisation details
Product details | |
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Name |
Lyfnua
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Agency product number |
EMEA/H/C/005476
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Active substance |
Gefapixant
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International non-proprietary name (INN) or common name |
gefapixant
|
Therapeutic area (MeSH) |
Cough
|
Anatomical therapeutic chemical (ATC) code |
R05DB29
|
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 | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
15/09/2023
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Contact address |
Waarderweg 39 |
Product information
Lyfnua - EMEA/H/C/005476 -
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
Cough and cold preparations
Therapeutic indication
Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.