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Ireland· IE-PA-EU/1/16/1146/001-009

Glyxambi 10 mg/5 mg film-coated tablets

A linagliptin and empagliflozin product containing empagliflozin + linagliptin, registered in Ireland by Boehringer Ingelheim International GmbH. The same ATC class is registered in 13 of our 19 countries.

ATC A10BD19

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedGlyxambi 10 mg/5 mg film-coated table…ATCA10BD19REGISTER NO.IE-PA-EU/1/16/1146/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Linagliptin and empagliflozin is registered in 13 of 19 countries.

Countries holding a registration under ATC A10BD19 (linagliptin and empagliflozin), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 9 of them publish a price we can compare per daily dose

Linagliptin and empagliflozin · ATC A10BD19

13 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • 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 + Linagliptin
Manufacturer
Boehringer Ingelheim International GmbH
Country
Ireland (IE)
ATC code
A10BD19
ATC class
Linagliptin and empagliflozin
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/16/1146/001-009

Regulatory notes

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

Same medicine, other countries

Linagliptin and empagliflozin in 11 other countries

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

All linagliptin and empagliflozin products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Glyxambi
  • Liechtenstein · Glyxambi
  • Norway · Glyxambi

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/c11808f8-077c-4f58-8952-398de08afd05
GET /v1/drugs/c11808f8-077c-4f58-8952-398de08afd05?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",
    "A10BD19"
  ],
  "strength": null,
  "pa_number": "EU/1/16/1146/001-009",
  "substances": [
    "Empagliflozin",
    "Linagliptin"
  ],
  "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "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 linagliptin 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.