Ireland· IE-PA-PA22998/001/001
Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets
A doxylamin, kombinationen (auch als sedativum) product containing pyridoxine hydrochloride + doxylamine hydrogen succinate, registered in Ireland by Exeltis Healthcare S.L.. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Doxylamin, kombinationen (auch als sedativum) is registered in 12 of 19 countries.
Countries holding a registration under ATC R06AA59 (doxylamin, kombinationen (auch als sedativum)), 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
Doxylamin, kombinationen (auch als sedativum) · ATC R06AA59
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Pyridoxine hydrochloride + Doxylamine hydrogen succinate
- Manufacturer
- Exeltis Healthcare S.L.
- Country
- Ireland (IE)
- ATC code
- R06AA59
- ATC class
- Doxylamin, Kombinationen (auch als Sedativum)
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA22998/001/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Doxylamin, kombinationen (auch als sedativum) in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaNUPERALItalfarmaco S.p.A., Milano
- United StatesBONJESTADuchesnay USA, Inc.
- SwitzerlandBonjesta
- CanadaALOG-DOXYLAMINE/PYRIDOXINEANALOG PHARMA CANADA INC.
- SpainBONJESTA 10 MG/10 MG COMPRIMIDOS GASTRORRESISTENTESExeltis Healthcare S.L.
- NetherlandsEmbagyn 20 mg/20 mg tabletten met gereguleerde afgifteExeltis Healthcare S.L
- FinlandBonjestaExeltis Healthcare S.L.
- FranceCARIBAN 10 mg/10 mg, gélule à libération modifiéeEFFIK
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Nuperal, Xonvea
- Belgium · Bonjesta, Navalit
- Bulgaria · Нюперал
- Cyprus · Nuperal
- Czechia · Nuperal, Xonvea
- Germany · Cariban, Cariban 10 Mg/10 Mg
- Denmark · Bonjesta, Xonvea
- Estonia · Xonvea
- Spain · Bonjesta, Cariban
- Finland · Bonjesta, Xonvea
- France · Cariban, Xonvea
- United Kingdom (Northern Ireland) · Xonvea
- Greece · Nuperal
- Hungary · Nuperal, Vombee
- Iceland · Xonvea
- Italy · Bonjesta, Embagyn
- Lithuania · Xonvea
- Luxembourg · Bonjesta, Bonjesta 20/20
- Latvia · Xonvea
- Netherlands · Embagyn, Navalit
- Norway · Embagyn, Xonvea
- Poland · Bonjesta, Xonvea
- Portugal · Bonjesta, Cariban
- Romania · Nuperal
- Sweden · Bonjesta, Xonvea
- Slovakia · Nuperal, Xonvea
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/01a21a00-e505-4c0e-87da-45c46814b9ae GET /v1/drugs/01a21a00-e505-4c0e-87da-45c46814b9ae?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": "Gastro-resistant tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"R06AA59"
],
"strength": null,
"pa_number": "PA22998/001/001",
"substances": [
"Pyridoxine hydrochloride",
"Doxylamine hydrogen succinate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "17/12/2021",
"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 doxylamin, kombinationen (auch als sedativum).
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.