Pradaxa
·
- Prescription status not stated
- Blood, clotting and anaemia
- Active substance
- Dabigatran etexilate
- Used in
- Blood, clotting and anaemia
- Made by
- Boehringer Ingelheim International GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dabigatran etexilate). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors.
Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus.
Dabigatran is metabolized to four different acyl glucuronides and both the glucuronides and dabigatran have similar pharmacological activity.
Dabigatran is eliminated primarily in the urine.
Coadministration of dabigatran with a high-fat meal delays the time to C max by approximately 2 hours but has no effect on the bioavailability of dabigatran; Dabigatran may be administered with or without food.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-13
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Boehringer Ingelheim International GmbH |
|---|---|
| Active substance | Dabigatran etexilate |
| Used in | Blood, clotting and anaemia |
| Classification | B01AE07 · Blood, clotting and anaemia |
| Authorised on | 2008-03-17 |
| Last updated by the regulator | 2026-03-13 |
| EMA product number | EMEA/H/C/000829 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.