Ireland· IE-PA-EU/1/11/731/001-006
Komboglyze 2.5 mg/850 mg film-coated tablets
A metformin and saxagliptin product containing saxagliptin + metformin hydrochloride, registered in Ireland by AstraZeneca AB. 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
Metformin and saxagliptin is registered in 12 of 19 countries.
Countries holding a registration under ATC A10BD10 (metformin and saxagliptin), 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
Metformin and saxagliptin · ATC A10BD10
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Saxagliptin + Metformin Hydrochloride
- Manufacturer
- AstraZeneca AB
- Country
- Ireland (IE)
- ATC code
- A10BD10
- ATC class
- Metformin and saxagliptin
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/11/731/001-006
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
3 interactions on record for metformin and saxagliptin.
Mechanism, severity and management for each pair, from a commercially licensed source — included with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Metformin and saxagliptin · interactions on record
3 records
3 more interactions with mechanism and management, from a commercially licensed source.
Sign in to checkSame medicine, other countries
Metformin and saxagliptin in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaKOMBOGLYZEAstraZeneca AB, Södertälje
- United StatesSaxagliptin and MetforminMylan Pharmaceuticals Inc.
- SwitzerlandKombiglyze XR
- United KingdomKomboglyze 2.5mg/1000mg tabletsDE Pharmaceuticals
- SpainKOMBOGLYZE 2,5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULAAstrazeneca Ab
- CanadaKOMBOGLYZEASTRAZENECA CANADA INC
- FinlandKomboglyzeAstraZeneca AB
- PolandKomboglyzeAstraZeneca AB
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- France · Saxagliptine/Metformine Biogaran
- Iceland · Komboglyze
- Liechtenstein · Komboglyze
- Malta · Saxagliptin/Metformin Pharos
- Norway · Komboglyze
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/adedf809-40b5-4457-95a0-c606765b31dc GET /v1/drugs/adedf809-40b5-4457-95a0-c606765b31dc?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": [
"A10BD10"
],
"strength": null,
"pa_number": "EU/1/11/731/001-006",
"substances": [
"Saxagliptin",
"Metformin Hydrochloride"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/11/2011",
"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 metformin and saxagliptin.
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.