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Medicines
Spain
Dabigatran etexilate

AEMPS 2022

Dabigatran etexilate

Pradaxa 20 MG Granulado Recubierto

23,06 mg granulado recubiertoSpainMarketedAuthorised 8 Mar 2022

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

PradaxaBrazil · Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.Same brand
PradaxaCanada · 150 MG · Capsule · Boehringer Ingelheim (Canada) LTD LteeSame brand
PradaxaCanada · 110 MG · Capsule · Boehringer Ingelheim (Canada) LTD LteeSame brand
PradaxaCanada · 75 MG · Capsule · Boehringer Ingelheim (Canada) LTD LteeSame brand
PradaxaEuropean Union · Boehringer Ingelheim International GmbHSame brand
PradaxaCroatiaSame brand
PradaxaItaly · Capsula rigida · Abacus Medicine A/SSame brand
PradaxaItaly · Capsula rigida · Boehringer Ingelheim International GMBH

More with the same substance on this register

Dabigatran Etexilato Alter Genericos 110 MG Capsulas Duras EfgDabigatran etexilate · 126,83 mg · cápsula duraSpain
Dabigatran Etexilato Alter Genericos 150 MG Capsulas Duras EfgDabigatran etexilate · 172,95 mg · cápsula dura

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same brand

🇳🇱Pradaxa 110 mg omhuld granulaatNetherlands · Omhuld granulaat · Boehringer Ingelheim International GmbHSame brand

🇳🇱Pradaxa 150 mg omhuld granulaatNetherlands · Omhuld granulaat · Boehringer Ingelheim International GmbHSame brand

🇳🇱Pradaxa 20 mg omhuld granulaatNetherlands · Omhuld granulaat · Boehringer Ingelheim International GmbHSame brand

🇷🇴PRADAXA 110mgRomania · 110mg · caps. · Boehringer Ingelheim International GMBHSame brand

🇷🇴PRADAXA 150mgRomania · 150mg · caps. · Boehringer Ingelheim International GMBHSame brand

🇷🇴PRADAXA 75mgRomania · 75mg · caps. · Boehringer Ingelheim International GMBHSame brand

🇷🇸Pradaxa®Serbia · 75mg · kapsula, tvrda · Boehringer Ingelheim Serbia D.O.O. BeogradSame brand

🇷🇸Pradaxa®Serbia · 75mg · kapsula, tvrda · Boehringer Ingelheim Serbia D.O.O. BeogradSame brand

🇷🇸Pradaxa®Serbia · 110mg · kapsula, tvrda · Boehringer Ingelheim Serbia D.O.O. BeogradSame brand

🇸🇦Pradaxa 110MG CapsulesSaudi Arabia · Boehringer IngelheimSame brand

🇸🇦Pradaxa 150MG CapsulesSaudi Arabia · Boehringer IngelheimSame brand

🇸🇦Pradaxa 75MG CapsulesSaudi Arabia · Boehringer IngelheimSame brand

🇸🇬Pradaxa 110 mg, hard capsulesSingapore · 110 mg · capsule · Boehringer Ingelheim Singapore Pte. LTD.Same brand

🇸🇬Pradaxa 150mg, Hard CapsulesSingapore · 150.00mg · capsule · Boehringer Ingelheim Singapore Pte. LTD.Same brand

🇸🇬Pradaxa 75mg, hard capsulesSingapore · 75 mg · capsule · Boehringer Ingelheim Singapore Pte. LTD.Same brand

🇺🇸PradaxaUnited States · 110MG BASE, 150MG BASE, 75MG BASE · capsule · Boehringer IngelheimSame brand

🇺🇸PradaxaUnited States · 110MG BASE/PACKET, 150MG BASE/PACKET, 20MG BASE/PACKET … · pellets · Boehringer IngelheimSame brand

🇧🇷DabgamBrazil · Cosmed Industria de Cosmeticos e Medicamentos S.A.Same substance

🇧🇷etexilato de dabigatranaBrazil · Brainfarma Indústria Química e Farmacêutica S.ASame substance

🇪🇺Dabigatran Etexilate AccordEuropean Union · Accord Healthcare S.L.U.Same substance

🇪🇺Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)European Union · Teva GmbHSame substance

🇭🇷Dabigatraneteksilat Genericon 110 mg tvrde kapsuleCroatia · Kapsula, tvrda · Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, AustrijaSame substance

🇭🇷Dabigatraneteksilat Genericon 150 mg tvrde kapsuleCroatia · Kapsula, tvrda · Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, AustrijaSame substance

🇮🇹AndabraItaly · Capsula rigida · Pharmathen S.A.Same substance

🇺🇸Dabigatran Etexilate MesylateUnited States · 110MG BASE, 150MG BASE, 75MG BASE · capsule · ApotexSame substance

Packs

Pack	Code	Status
PRADAXA 20 MG GRANULADO RECUBIERTO, 60 sobres	732863

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Dabigatran etexilate
Strength: 23,06 mg
Dosage form: granulado recubierto
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 8 Mar 2022
Registration: 108442025
Marketing authorisation holder: Boehringer Ingelheim International Gmbh
Procedure: EU centralised
Supply: Diagnóstico Hospitalario

🇪🇸Spain

AEMPSDabigatran Etexilato Cinfa 110 MG Capsulas Duras EfgDabigatran etexilate · 126,84 mg · cápsula dura🇪🇸Spain

AEMPSDabigatran Etexilato Cinfa 150 MG Capsulas Duras EfgDabigatran etexilate · 172,95 mg · cápsula dura🇪🇸Spain

AEMPSDabigatran Etexilato Combix 110 MG Capsulas Duras EfgDabigatran etexilate · 126,83 mg · cápsula dura🇪🇸Spain

AEMPSDabigatran Etexilato Combix 150 MG Capsulas Duras EfgDabigatran etexilate · 172,95 mg · cápsula dura🇪🇸Spain

AEMPSDabigatran Etexilato Krka 110 MG Capsulas Duras EfgDabigatran etexilate · 126,87 mg · cápsula dura🇪🇸Spain

AEMPSDabigatran Etexilato Krka 150 MG Capsulas Duras EfgDabigatran etexilate · 173,01 mg · cápsula dura🇪🇸Spain

AEMPSDabigatrán Etexilato Normon 110 MG Cápsulas Duras EfgDabigatran etexilate · 126,83 mg · cápsula dura🇪🇸Spain

AEMPSDabigatrán Etexilato Normon 150 MG Cápsulas Duras EfgDabigatran etexilate · 172,95 mg · cápsula dura🇪🇸Spain

AEMPSDabigatrán Etexilato Pensa 110 MG Cápsulas Duras EfgDabigatran etexilate · 126,83 mg · cápsula dura🇪🇸Spain

AEMPSDabigatran Etexilato Pensa 150 MG Capsulas Duras EfgDabigatran etexilate · 172,95 mg · cápsula dura🇪🇸Spain