Ireland· IE-PA-EU/1/21/1613/001-004
LYFNUA 45 mg Film-coated tablet
A gefapixant product containing gefapixant, registered in Ireland by Merck Sharp & Dohme BV,. The same ATC class is registered in 13 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Gefapixant is registered in 13 of 19 countries.
Countries holding a registration under ATC R05DB29 (gefapixant), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Gefapixant · ATC R05DB29
13 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Gefapixant
- Manufacturer
- Merck Sharp & Dohme BV,
- Country
- Ireland (IE)
- ATC code
- R05DB29
- ATC class
- Gefapixant
- Defined daily dose
- 90 mg, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1613/001-004
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Gefapixant in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaLYFNUAMerck Sharp & Dohme B.V., Haarlem
- SpainLYFNUA 45 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMerck Sharp & Dohme B.V.
- FinlandLyfnuaMerck Sharp & Dohme B.V.
- FranceLYFNUA 45 mg, comprimé pelliculéMERCK SHARP & DOHME (PAYS-BAS)
- IcelandLyfnuaMerck Sharp & Dohme B.V.*
- NetherlandsLyfnua 45 mg filmomhulde tablettenMerck Sharp & Dohme B.V.
- NorwayLyfnuaMerck Sharp & Dohme B.V.
- PolandLyfnuaMerck Sharp & Dohme B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Lyfnua
- Liechtenstein · Lyfnua
- Norway · Lyfnua
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/dbd0437d-20a3-4bd7-8a53-d2b67838b998 GET /v1/drugs/dbd0437d-20a3-4bd7-8a53-d2b67838b998?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"R05DB",
"R05DB29"
],
"strength": null,
"pa_number": "EU/1/21/1613/001-004",
"substances": [
"Gefapixant"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "15/09/2023",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about gefapixant.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.