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dabigatran etexilate

Pradaxa · ATC code B01AE07

Also known as: Dabigatranetexilat · Brand names: Pradaxa, Dabahib, Dabigatran Etexilaat Biocon, Dabigatran G.L., Gribero, Andabra, Dabigatran Beta, Dabigatran Tad, Dabigatran Welding, Dabweld, Prabixan, Robada

Key facts
Active substance
dabigatran etexilate
Drug class
Direct thrombin inhibitor
ATC code
B01AE07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Pradaxa 75 mg hard capsules · Pradaxa 110 mg hard capsules · Pradaxa 150 mg hard capsules · Pradaxa 20 mg coated granules / Pradaxa 30 mg coated granules / Pradaxa 40 mg coated granules
Marketing authorisation holder
Boehringer Ingelheim International GmbH
Information as of
2026-10-27

Key facts

Dabigatran etexilate is an oral direct thrombin inhibitor used to prevent and treat venous thromboembolism and to prevent stroke in non-valvular atrial fibrillation.

What it is used for

  • Primary prevention of VTE after elective total hip or knee replacement (adults)
  • Prevention of stroke and systemic embolism in non-valvular atrial fibrillation with risk factors (adults)
  • Treatment and prevention of recurrent DVT and PE (adults)
  • Treatment and prevention of recurrent VTE in children up to <18 years

Dosing

  • Knee/hip replacement: 110 mg 1-4 hours after surgery, then 220 mg once daily for 10 days (knee) or 28-35 days (hip).
  • Joint replacement with moderate renal impairment (CrCL 30-50 mL/min), verapamil, amiodarone, quinidine, or age 75 or above: 75 mg, then 150 mg once daily.
  • Atrial fibrillation and DVT/PE: 150 mg twice daily (DVT/PE after at least 5 days of parenteral anticoagulant).
  • Age ≥80 years or with verapamil: 110 mg twice daily; between 75-80 years based on individual assessment.
  • Assess renal function (CrCL by Cockcroft-Gault) before and during treatment.
  • Children: dose by weight and age from the tables for each formulation in the full text.

Contraindications

  • Severe renal impairment (CrCL <30 mL/min) in adults; eGFR <50 mL/min/1.73 m2 in children
  • Active clinically significant bleeding or lesions at significant risk of major bleeding
  • Concomitant other anticoagulants, except under specific circumstances
  • Concomitant certain strong P-gp inhibitors such as ketoconazole
  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Bleeding can occur at any site; an unexplained fall in haemoglobin or blood pressure should prompt a search for bleeding
  • The specific reversal agent idarucizumab is available for adults; haemodialysis can remove dabigatran
  • Higher rates of major gastrointestinal bleeding, with increased risk in the elderly
  • Platelet inhibitors, NSAIDs, oesophagitis, gastritis or reflux increase GI bleeding risk

Side effects

  • Bleeding is the most commonly reported event
  • Common: haemoglobin decreased
  • Uncommon: anaemia, drug hypersensitivity
  • Rare: thrombocytopenia, anaphylactic reaction, angioedema, urticaria

Interactions

  • P-gp inhibitors increase dabigatran levels; some are contraindicated, others need dose reduction or close surveillance
  • Verapamil, amiodarone, quinidine: reduced dose
  • Other anticoagulants, platelet inhibitors and NSAIDs increase bleeding risk

Pregnancy and breastfeeding

  • Should not be used in pregnancy unless clearly necessary; women of childbearing potential should avoid pregnancy.
  • Breast-feeding should be discontinued during treatment.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • DabahibG.L. Pharma Gmbh · 1 register entry
  • Dabigatran Etexilaat BioconBiocon Pharma Malta I Limited · 1 register entry
  • Dabigatran G.L.G.L. Pharma Gmbh · 2 register entries
  • Dabigatranetexilat1a Pharma Gmbh, Gedeon Richter Plc., Viatris Limited, Sandoz Gmbh, Aliud Pharma Gmbh, Hexal Pharma Gmbh, Reddy Holding Gmbh, Stada Arzneimittel Gmbh, Hcs Bvba · 10 register entries
  • GriberoSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AndabraPharmathen S.A. · 1 register entry
  • Dabigatran BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Dabigatran TadTad Pharma Gmbh · 1 register entry
  • Dabigatran WeldingAbdi Farma Gmbh · 1 register entry
  • Dabigatranetexilat1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Laboratorios Liconsa S.A., Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Viatris Germany Gmbh, Zentiva Pharma Gmbh, Aliud Pharma Gmbh, Stadapharm Gmbh · 12 register entries
  • DabweldWelding Gmbh & Co. Kg · 1 register entry
  • PrabixanZaklady Farmaceutyczne Polpharma S.A. · 1 register entry
  • RobadaStada Arzneimittel Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • PradaxaBOEHRİNGER INGELHEİM İLAÇ TİC. A.Ş. · 5 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Dabigatran Etexilaat Hcs, Dabigatran Etexilaat Liconsa, Dabigatran Etexilate, Dabigatran Sandoz, Dabigatranetexilat Liconsa
Bulgaria
Dabigatran Etexilate Laboratorios Liconsa, Dabigatran G.L. Pharma, Dabigatran Sanexcel, Gribero, Propipin, Гладиус, Гриберо, Дабигатран Етексилат Полфарма, Даксанло, Пропипин, Телексер
Croatia
Dabigatraneteksilat Abela, Dabigatraneteksilat Gedeon Richter, Dabigatraneteksilat Genericon, Dabigatraneteksilat Liconsa, Dabigatraneteksilat Stada, Dabigatraneteksilat Viatris, Dabigatraneteksilat Zentiva, Daogax, Daxanlo, Fluxitra, Gribero
Cyprus
Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Viatris, Dabigatran Extexilate Viatris, Daxanlo
Czechia
Dabigatran Etexilate G.L. Pharma, Dabigatran Etexilate Laboratorios Liconsa, Dabigatran Etexilate Reddy, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Sanexcel, Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris, Dabigatran Etexilát +pharma, Danengo, Daroxomb, Daxanlo, Fluxitra, Gribero, Robada, Sianta, Telexer
Denmark
Andabra, Dabigatran Etexilate "sandoz", Dabigatran Etexilate Glenmark, Dabigatran Etexilate Krka, Dabigatran Etexilate Medical Valley, Dabigatran Etexilate Orion, Dabigatran Etexilate Reddy, Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris, Dabigatran Etexilate Zentiva, Dabigatranetexilat Alembic Pharmaceuticals Europe, Dabigatranetexilat Gedeon Richter
Estonia
Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris, Dabigatran Exilate Viatris, Dabigtaran Etexilate Stada, Danengo, Daxanlo, Gribero, Telexer
Finland
Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Glenmark, Dabigatran Etexilate Krka, Dabigatran Etexilate Liconsa, Dabigatran Etexilate Orion, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris
France
Dabigatran Etexilate Biogaran, Dabigatran Etexilate Eg, Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Hcs, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Viatris Sante, Dabigatran Etexilate Welding, Dabigatran Etexilate Zentiva K.S
Greece
Andabra, Dabigatran Etexilate Ariti, Dabigatran Etexilate Billev Pharma, Dabigatran Etexilate Stada, Dabigatran Etexilate Zentiva, Dabigatran Exetilate Viatris, Daxanlo, Daxirem, Gribero, Tranigran
Hungary
Dabigatran Etexilate Laboratorios Liconsa, Dabigatran Etexilate Sandoz, Dabigatran Sanexcel, Danengo, Daroxomb, Daxanlo, Sianta, Telexer
Iceland
Dabigatran Etexilat Alembic, Dabigatran Etexilate Accord, Dabigatran Etexilate Krka, Dabigatran Etexilate Medical Valley, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada Nordic, Dabigatran Etexilate Teva, Dabigatran Etexilate Viatris, Pradaxa
Ireland
Dabigatran Etexilate Clonmel Healthcare, Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Krka, Dabigatran Etexilate N/A, Dabigatran Etexilate Rowa
Italy
Andabra, Auralgan, Dabigatran Etexilaat Biocon, Dabigatran Etexilato Abdi, Dabigatran Etexilato Doc, Dabigatran Etexilato Dr. Reddy’s, Dabigatran Etexilato Eg Stada, Dabigatran Etexilato Gedeon Richter, Dabigatran Etexilato Hcs, Dabigatran Etexilato Medical Valley, Dabigatran Etexilato Olpha, Dabigatran Etexilato Sandoz, Dabigatran Etexilato Viatris, Dabigatran Etexilato Zim, Dabigatran Pensa, Dabikaste Glenmark, Dangard, Daroxomb
Latvia
Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada, Dabigatran Etexilate Tad, Dabigatran Etexilate Viatris, Danengo, Daxanlo, Gribero, Telexer
Liechtenstein
Dabigatran Etexilate Accord, Dabigatran Etexilate Teva, Dabigatranetexilat Gedeon Richter, Pradaxa
Lithuania
Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris, Danengo, Daxanlo, Gribero, Telexer
Luxembourg
Dabigatran Etexilate Eg, Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Liconsa, Dabigatran Etexilate Viatris
Malta
Abagat, Auralgan, Dabahib, Dabigatran Etexilate Adair, Dabigatran Etexilate Biocon, Dabigatran Etexilate Clonmel, Dabigatran Etexilate Doc, Dabigatran Etexilate Ebewe, Dabigatran Etexilate Galenicum, Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Gemax Pharma, Dabigatran Etexilate Gln, Dabigatran Etexilate Medreg, Dabigatran Etexilate Polpharma, Dabigatran Etexilate Sag, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris, Dabigatran Etexilate Zentiva, Dabigatran Pentafarma, Dangard, Daroxomb, Daxirem, Fluxitra, Privenax, Robada, Tranigran
Netherlands
Dabigatran Etexilaat Alembic, Dabigatran Etexilaat Biocon, Dabigatran Etexilaat Centrafarm, Dabigatran Etexilaat Gedeon Richter, Dabigatran Etexilaat Hcs, Dabigatran Etexilaat Reddy, Dabigatran Etexilaat Sandoz, Dabigatran Etexilaat Viatris, Dabigatran Etexilaat Xiromed, Dabigatran Etexilate Viatris
Norway
Dabigatran Accord, Dabigatran Etexilate Accord, Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Glenmark, Dabigatran Etexilate Krka, Dabigatran Etexilate Medical Valley, Dabigatran Etexilate Orion, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada Nordic, Dabigatran Etexilate Teva, Dabigatran Etexilate Viatris, Dabigatran Etexilate Zentiva, Dabigatraneteksilat Alembic, Pradaxa
Poland
Abagat, Dabigartan Sanexcel, Dabigatran Eteksylan Polpharma, Dabigatran Eteksylan Stada, Dabigatran Etexilate +pharma, Dabigatran Etexilate G.L., Dabigatran Etexilate Laboratorios Liconsa, Dabigatran Etexilate Medical Valley, Dabigatran Etexilate Medreg, Dabigatran Etexilate Orion, Dabigatran Etexilate Reddy, Danengo, Daroxomb, Daxanlo, Gribero, Mirexan, Prabixan, Sianta, Telexer, Wasedoc, Zali
Portugal
Dabigatran Azevedos, Dabigatran Etexilate Glenmark Arzneimittel Gmbh, Dabigatrano Alter, Dabigatrano Bluepharma, Dabigatrano Etexilato, Dabigatrano Farmoz, Stada Stada
Romania
Dabigatran Etexilat Dr. Reddy’s, Dabigatran Etexilat Gemax Pharma, Dabigatran Etexilat Laboratorios Liconsa, Dabigatran Etexilat Sanexcel, Dabigatran Etexilat Viatris, Dabigatran Etexilate Liconsa, Daroxomb, Daxanlo, Gribero, Sianta, Telexer, Wasedoc
Slovakia
Dabahib, Dabigatran Etexilate Glenmark, Dabigatran Etexilate Reddy, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Sanexcel, Dabigatran-Etexilát G.L. Pharma, Dabigatran-Etexilát Stada Arzneimittel, Danengo, Daroxomb, Daxanlo, Gribero, Robada, Sianta, Telexer
Slovenia
Dabigatraneteksilat Gedeon Richter, Dabigatraneteksilat Hcs, Dabigatraneteksilat Krka, Dabigatraneteksilat Tad, Dabigatraneteksilat Viatris, Danengo, Daxanlo, Gribero
Spain
Andabra, Dabidose, Dabigatran Dr. Reddys, Dabigatran Etexilato Krka, Dabigatran Etexilato Liconsa, Dabigatran Etexilato Sandoz, Dabigatrán Dr. Reddys, Dabigatrán Etexilato, Dabiprax, Dabweld, Placasod, Privenax, Sinplak
Sweden
Dabigatran Etexilate G.L. Pharma, Dabigatran Etexilate Gedeon Richter, Dabigatran Etexilate Glenmark, Dabigatran Etexilate Krka, Dabigatran Etexilate Laboratorios Liconsa, Dabigatran Etexilate Liconsa, Dabigatran Etexilate Medical Valley, Dabigatran Etexilate Olpha, Dabigatran Etexilate Orion, Dabigatran Etexilate Reddy, Dabigatran Etexilate Sandoz, Dabigatran Etexilate Stada, Dabigatran Etexilate Viatris, Dabigatran Etexilate Zentiva, Dabigatranetexilat Alembic

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Pradaxa – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/pradaxa-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC B01AE.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.