Lyfnua (gefapixant)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- gefapixant
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Cough
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005476
- ATC
- R05DB29
- Official record
- www.ema.europa.eu
Indication
Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Gefzuris Application withdrawn · Merck Sharp & Dohme B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.