SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| DABITRAN | 75 mg | Capsule, hard · Oral use | 60 Blister | SAR 250.25 | Generic · Prescription | Saudi Amarox | Valid |
| DABITRAN | 75 mg | Capsule, hard · Oral use | 30 Blister | SAR 125.10 | Generic · Prescription | Saudi Amarox | Valid |
| DABITRAN | 150 mg | Capsule, hard · Oral use | 60 Blister | SAR 250.25 | Generic · Prescription | Saudi Amarox | Valid |
| DABITRAN | 150 mg | Capsule, hard · Oral use | 30 Blister | SAR 125.10 | Generic · Prescription | Saudi Amarox | Valid |
| DABITRAN | 110 mg | Capsule · Oral use | 30 Blister | SAR 125.10 | Generic · Prescription | Saudi Amarox | Valid |
| DABITRAN | 110 mg | Capsule · Oral use | 60 Blister | SAR 250.25 | Generic · Prescription | Saudi Amarox | Valid |
| Digatra | 110 mg | Capsule · Oral use | 30 Blister | SAR 125.10 | Generic · Prescription | Alhobail Pharm | Valid |
| Digatra | 75 mg | Capsule · Oral use | 30 Blister | SAR 109.95 | Generic · Prescription | Alhobail Pharm | Valid |
| Digatra | 150 mg | Capsule · Oral use | 30 Blister | SAR 125.10 | Generic · Prescription | Alhobail Pharm | Valid |
| PRADAXA 110MG CAPSULES | 110 mg | Capsule, hard · Oral use | 60 Blister | SAR 308.00 | NCE · Prescription | BOEHRINGER INGELHEIM | Valid |
| PRADAXA 110MG CAPSULES | 110 mg | Capsule, hard · Oral use | 30 Blister | SAR 154.00 | NCE · Prescription | BOEHRINGER INGELHEIM | Valid |
| PRADAXA 150MG CAPSULES | 150 mg | Capsule, hard · Oral use | 60 Blister | SAR 308.00 | NCE · Prescription | BOEHRINGER INGELHEIM | Valid |
| PRADAXA 75MG CAPSULES | 75 mg | Capsule, hard · Oral use | 30 Blister | SAR 154.00 | NCE · Prescription | BOEHRINGER INGELHEIM | Valid |
| PRADAXA 75MG CAPSULES | 75 mg | Capsule, hard · Oral use | 60 Blister | SAR 308.00 | NCE · Prescription | BOEHRINGER INGELHEIM | Valid |
Indications — CHI Daman Drug Formulary
ANTIPHOSPHOLIPID SYNDROME; ATRIAL FIBRILLATION; CARDIOMYOPATHY; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HIP AND KNEE REPLACEMENT SURGERY; HODGKIN'S LYMPHOMA; ISCHEMIC STROKE; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; MYELOFIBROSIS-ADVERSE REACTION MANAGEMENT; POLYCYTHEMIA VERA - THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY ARTERIAL HYPERTENSION; PULMONARY EMBOLISM; T-CELL LYMPHOMA-RENAL TOXICITY; VENOUS THROMBOEMBOLISM DISEASE (VTE)-TREATMENT
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| PRADAXA | EQ 75MG BASE; EQ 150MG BASE; EQ 110MG BASE | capsule · oral | BOEHRINGER INGELHEIM | Prescription | 19 Oct 2010 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 150MG BASE; EQ 110MG BASE | capsule · oral | ALKEM LABS LTD | Prescription | 11 Mar 2020 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 150MG BASE; EQ 110MG BASE | capsule · oral | HETERO LABS LTD III | Prescription | 6 May 2020 |
| PRADAXA | EQ 20MG BASE/PACKET; EQ 30MG BASE/PACKET; EQ 40MG BASE/PACKET; EQ 50MG BASE/PACKET; EQ 110MG BASE/PACKET; EQ 150MG BASE/PACKET | pellets · oral | BOEHRINGER INGELHEIM | Prescription | 21 Jun 2021 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 110MG BASE; EQ 150MG BASE | capsule · oral | APOTEX | Prescription | 15 Dec 2023 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 150MG BASE; EQ 110MG BASE | capsule · oral | MSN | Prescription | 22 May 2024 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 150MG BASE; EQ 110MG BASE | capsule · oral | ALEMBIC | Prescription | 14 Jun 2024 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 110MG BASE; EQ 150MG BASE | capsule · oral | DR REDDYS | Prescription | 28 Jan 2025 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 150MG BASE | capsule · oral | MYLAN | Prescription | 3 Feb 2025 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 110MG BASE; EQ 150MG BASE | capsule · oral | AUROBINDO PHARMA | Prescription | 14 May 2025 |
| DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE; EQ 150MG BASE; EQ 110MG BASE | capsule · oral | BRECKENRIDGE | Discontinued | 19 Dec 2024 |
EMA European Union — centrally authorised medicines
Pradaxa Boehringer Ingelheim International GmbH · Authorised · authorised 17 Mar 2008 · ATC B01AE07
Therapeutic indication (EMA)
Pradaxa 75 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Pradaxa 110 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Pradaxa 150 mg Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Dabigatran Etexilate Accord Accord Healthcare S.L.U. · Authorised · authorised 26 May 2023 · ATC B01AE07
Therapeutic indication (EMA)
Prevention of venous thromboembolic events
Therapeutic indication (EMA)
Dabigatran etexilate Leon Farma 75 mg Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Dabigatran etexilate Leon Farma 110 mg Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Dabigatran etexilate Leon Farma 150 mg Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.
Therapeutic indication (EMA)
Prevention of venous thromboembolic events
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| APO-DABIGATRAN | 02468891 | 75 MG | CAPSULE · ORAL | APOTEX INC |
| APO-DABIGATRAN | 02468905 | 110 MG | CAPSULE · ORAL | APOTEX INC |
| APO-DABIGATRAN | 02468913 | 150 MG | CAPSULE · ORAL | APOTEX INC |
| PRADAXA | 02312441 | 110 MG | CAPSULE · ORAL | BOEHRINGER INGELHEIM (CANADA) LTD LTEE |
| PRADAXA | 02358808 | 150 MG | CAPSULE · ORAL | BOEHRINGER INGELHEIM (CANADA) LTD LTEE |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | DABIGATRAN ETEXILATE 110 MG CP | $0.93752 | per EA | 23 Sep 2026 |
| US NADAC | DABIGATRAN ETEXILATE 150 MG CP | $0.79456 | per EA | 23 Sep 2026 |
| US NADAC | DABIGATRAN ETEXILATE 75 MG CAP | $0.75027 | per EA | 23 Sep 2026 |
| US NADAC | PRADAXA 110 MG CAPSULE | $3.16648 | per EA | 22 Jul 2026 |
| US NADAC | PRADAXA 150 MG CAPSULE | $3.1597 | per EA | 23 Sep 2026 |
| US NADAC | PRADAXA 75 MG CAPSULE | $3.16697 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Dabigatran etexilate 110mg capsules | £1.00 | 10 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 110mg capsules | £6.00 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 110mg granules sachets sugar free | £270.00 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 150mg capsules | £3.42 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 150mg granules sachets sugar free | £270.00 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 20mg granules sachets sugar free | £270.00 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 30mg granules sachets sugar free | £270.00 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 40mg granules sachets sugar free | £270.00 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 50mg granules sachets sugar free | £270.00 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 75mg capsules | £8.50 | 10 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Dabigatran etexilate 75mg capsules | £51.00 | 60 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 10.2. Medicines affecting coagulation · core
Other specified atrial fibrillation; Venous thromboembolism
Oral > Solid: 110 mg; 150 mg
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.