Ireland· IE-PA-PA1347/118/001
Dapagliflozin/Metformin Krka 5 mg/850 mg film-coated tablets
A metformin and dapagliflozin product containing dapagliflozin propanediol monohydrate + metformin hydrochloride, registered in Ireland by KRKA, d.d., Novo mesto. 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
Metformin and dapagliflozin is registered in 13 of 19 countries.
Countries holding a registration under ATC A10BD15 (metformin and dapagliflozin), 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
Metformin and dapagliflozin · ATC A10BD15
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Dapagliflozin propanediol monohydrate + Metformin Hydrochloride
- Manufacturer
- KRKA, d.d., Novo mesto
- Country
- Ireland (IE)
- ATC code
- A10BD15
- ATC class
- Metformin and dapagliflozin
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1347/118/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
1 interaction on record for metformin and dapagliflozin.
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 dapagliflozin · interactions on record
1 record
1 more interaction with mechanism and management, from a commercially licensed source.
Sign in to checkSame medicine, other countries
Metformin and dapagliflozin in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/e8d8828b-a6ee-44b4-bc8a-d3562e31fccd GET /v1/drugs/e8d8828b-a6ee-44b4-bc8a-d3562e31fccd?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": [
"A10BD15"
],
"strength": null,
"pa_number": "PA1347/118/001",
"substances": [
"Dapagliflozin propanediol monohydrate",
"Metformin Hydrochloride"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "29/08/2025",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0090-143-003"
}See everything about metformin 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.