Ireland· IE-PA-EU/1/16/1108/001-004
Qtern 5 mg/10 mg film-coated tablets
A saxagliptin and dapagliflozin product containing dapagliflozin + saxagliptin, registered in Ireland by AstraZeneca AB. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Saxagliptin and dapagliflozin is registered in 11 of 19 countries.
Countries holding a registration under ATC A10BD21 (saxagliptin and dapagliflozin), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Saxagliptin and dapagliflozin · ATC A10BD21
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Dapagliflozin + Saxagliptin
- Manufacturer
- AstraZeneca AB
- Country
- Ireland (IE)
- ATC code
- A10BD21
- ATC class
- Saxagliptin and dapagliflozin
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/16/1108/001-004
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Saxagliptin and dapagliflozin in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandQtern, FilmtablettenAstraZeneca AG
- SpainQTERN 5 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULAAstrazeneca Ab
- United KingdomQtern 5mg/10mg tabletsAstraZeneca UK Ltd
- IcelandQternAstraZeneca AB*
- NetherlandsQtern, filmomhulde tablettenAstraZeneca AB
- PolandQternAstraZeneca AB
- SwedenQtern 5 mg/10 mg Filmdragerad tablettAstraZeneca AB
- United StatesDAPAGLIFLOZIN AND SAXAGLIPTINNovadoz Pharmaceuticals LLC
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Qtern
- Liechtenstein · Qtern
- Norway · Qtern
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/e12176d8-148b-4b38-87fc-1080fdcdb110 GET /v1/drugs/e12176d8-148b-4b38-87fc-1080fdcdb110?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": [
"A10BD",
"A10BD21"
],
"strength": null,
"pa_number": "EU/1/16/1108/001-004",
"substances": [
"Dapagliflozin",
"Saxagliptin"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "15/07/2016",
"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 saxagliptin and dapagliflozin.
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.