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Germany· DE-A57-495b7eabd66d5b16

Dabigatranetexilat Al

A medicinal product containing dabigatran, registered in Germany by Aliud Pharma Gmbh.

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedDabigatranetexilat AlATC—REGISTER NO.DE-A57-495b7eabd66d5b…PACKS LISTED0CHECKEDSeptember 30, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dabigatranAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

EMA Article 57 (European Union)
Active substance
Dabigatran
Manufacturer
Aliud Pharma Gmbh
Country
Germany (DE)
ATC code
—
Reimbursed
Not published by this register
Source register
EMA Article 57 (European Union)
Last checked
September 30, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

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

Same medicine, other countries

Dabigatran in 2 other countries

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

All dabigatran products

Authorised across Europe · EMA

The same active substance is authorised in 20 EEA countries. Names it is sold under:

  • Austria · Dabigatranetexilat Aliud Pharma, Dabigatranetexilat Stada Arzneimittel
  • Belgium · Dabigatran Etexilate Eg (Eurogenerics) Nv, Dabigatran Etexilate Eg (Eurogenerics)nv
  • Bulgaria · Сианта
  • Czechia · Tuxanuva
  • Spain · Dabigatrán Etexilato
  • Finland · Dabigatran Etexilate Stada
  • France · Dabigatran Etexilate Eg Labo
  • United Kingdom (Northern Ireland) · Dabigatran Etexilate Genus Pharmaceuticals Ltd., Dabigatran Etextilate Genus Pharmaceuticals Ltd.
  • Croatia · Tuxanuva
  • Hungary · Dabigatrán-Etexilát Stada, Sianta
  • Ireland · Dabigatran Etexilate Clonmel
  • Iceland · Dabigatran Etexilate Stada
  • Italy · Dabigatran Etexilato Eg Spa
  • Luxembourg · Dabigatran Etexilate Eg (Eurogenerics), Dabigatran Etexilate Eg (Eurogenerics) Nv
  • Malta · Sianta
  • Netherlands · Dabigatran Etexilaat Cf, Dabigatran Etexilaat Stada
  • Poland · Sianta, Tuxanuva
  • Romania · Sianta
  • Sweden · Dabigatran Etexilate Stada
  • Slovakia · Dabigatran Etexilate Stada, Sianta

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 EMA Article 57 (European Union). 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/65078bc9-dbe5-4843-9b59-81f3e20274eb
GET /v1/drugs/65078bc9-dbe5-4843-9b59-81f3e20274eb?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.

{
  "pzn": null,
  "route": "Oral Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Dabigatran",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}
API referenceMCP serverPlans

See everything about dabigatran.

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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