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Spain· ES:89375

DABIGATRAN ETEXILATO SAG 110 MG CAPSULAS DURAS EFG

A medicinal product containing dabigatrán, registered in Spain by Galenicum Health S.L.U..

Checked against AEMPS CIMA (Spain) on

Informational only — not a medical device.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedDABIGATRAN ETEXILATO SAG 110 MG CAPSU…ATC—REGISTER NO.ES:89375PACKS LISTED3CHECKEDSeptember 12, 2026

The record

At a glance

AEMPS CIMA (Spain)
Active substance
dabigatrán
Manufacturer
Galenicum Health S.L.U.
Country
Spain (ES)
ATC code
—
Reimbursed
Not published by this register
Source register
AEMPS CIMA (Spain)
Last checked
September 12, 2026

Packs & prices · 3

3 priced
  • cima_codigo
    764400
    10
    EUR 5.51
  • cima_codigo
    764401
    30
    EUR 16.53
  • cima_codigo
    764402
    60
    EUR 33.06

Regulatory notes

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

Same medicine, other countries

Dabigatrán in 2 other countries

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

All dabigatrán 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
  • Germany · Dabigatranetexilat Al, Dabigatranetexilat Stada
  • 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 AEMPS CIMA (Spain). 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/f03d5aad-48aa-409e-833d-6043ba04f13c
GET /v1/drugs/f03d5aad-48aa-409e-833d-6043ba04f13c?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.

{
  "cpresc": "Medicamento Sujeto A Prescripción Médica",
  "estado": "{\"aut\":1708686159000}",
  "nregistro": "89375",
  "substance": "dabigatrán"
}

See everything about dabigatrán.

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.