Spain· ES:89509
BIGETRA 150 MG CAPSULAS DURAS
A medicinal product containing dabigatrán, registered in Spain by Adamed Laboratorios S.L.U..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- dabigatrán
- Manufacturer
- Adamed Laboratorios 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 · 1
1 priced- cima_codigo76478060EUR 45.08
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.
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/c6512e06-26ac-4010-a124-2943cac27d87 GET /v1/drugs/c6512e06-26ac-4010-a124-2943cac27d87?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\":1713779048000,\"rev\":1785998044000}",
"nregistro": "89509",
"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.