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Ireland· IE-PA-PA1347/122/004

Empagliflozin/Metformin Krka 12.5 mg/1000 mg film-coated tablets

A metformin and empagliflozin product containing empagliflozin + metformin hydrochloride, registered in Ireland by KRKA, d.d., Novo mesto. The same ATC class is registered in 13 of our 19 countries.

ATC A10BD20

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedEmpagliflozin/Metformin Krka 12.5 mg/…ATCA10BD20REGISTER NO.IE-PA-PA1347/122/004PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about empagliflozin + metformin hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Metformin and empagliflozin is registered in 13 of 19 countries.

Countries holding a registration under ATC A10BD20 (metformin and empagliflozin), 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
Search metformin and empagliflozin products by name

Metformin and empagliflozin · ATC A10BD20

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Empagliflozin + Metformin Hydrochloride
Manufacturer
KRKA, d.d., Novo mesto
Country
Ireland (IE)
ATC code
A10BD20
ATC class
Metformin and empagliflozin
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA1347/122/004

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Metformin and empagliflozin in 13 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All metformin and empagliflozin products

Authorised across Europe · EMA

The same active substance is authorised in 22 EEA countries. Names it is sold under:

  • Austria · Empagliflozin/Metformin Hcs
  • Belgium · Empagliflozine/Metformine Hcl Hcs
  • Bulgaria · Empafel Met 5 Mg/850 Mg, Емпафел Мет
  • Cyprus · Empagliflozin/Metformin Tad
  • Czechia · Mempoglyn
  • Denmark · Empagliflozin/Metformin Krka
  • Estonia · Mempoglyn
  • Spain · Empagliflozina/Metformina Krka
  • Greece · Mempoglyn
  • Croatia · Mempoglyn
  • Hungary · Mempoglyn
  • Iceland · Appref, Empagliflozin-Metformin Adalvo
  • Liechtenstein · Synjardy
  • Lithuania · Mempoglyn
  • Luxembourg · Empagliflozin/Metformin Hcl Ab
  • Latvia · Mempoglyn
  • Malta · Appref, Empagliflozin-Metformin Adalvo
  • Netherlands · Appref, Empagliflozine/Metformine Hcl Hcs
  • Norway · Empagliflozin/Metformin Krka, Synjardy
  • Portugal · Empagliflozina + Metformina Aurobindo, Empagliflozina + Metformina Generis
  • Romania · Mempoglyn
  • Slovenia · Emameten, Empagliflozin/Metformin Krka

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/3b5eee29-10df-4682-b8d3-fa71ecae0f9f
GET /v1/drugs/3b5eee29-10df-4682-b8d3-fa71ecae0f9f?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": [
    "A10BD20"
  ],
  "strength": null,
  "pa_number": "PA1347/122/004",
  "substances": [
    "Empagliflozin",
    "Metformin Hydrochloride"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "29/05/2026",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about metformin and empagliflozin.

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.

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