Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Pradaxa 20 mg coated granules.
Pradaxa 30 mg coated granules.
Pradaxa 40 mg coated granules.
Pradaxa 50 mg coated granules.
Pradaxa 110 mg coated granules.
Pradaxa 150 mg coated granules.
| Pharmaceutical Form |
|---|
|
Coated granules. Yellowish coated granules. |
Each sachet contains coated granules with 20 mg dabigatran etexilate (as mesilate).
Each sachet contains coated granules with 30 mg dabigatran etexilate (as mesilate).
Each sachet contains coated granules with 40 mg dabigatran etexilate (as mesilate).
Each sachet contains coated granules with 50 mg dabigatran etexilate (as mesilate).
Each sachet contains coated granules with 110 mg dabigatran etexilate (as mesilate).
Each sachet contains coated granules with 150 mg dabigatran etexilate (as mesilate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dabigatran |
Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity. After oral administration, dabigatran etexilate is rapidly absorbed and converted to dabigatran by esterase-catalysed hydrolysis in plasma and in the liver. Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma. |
| List of Excipients |
|---|
|
Tartaric acid |
Aluminium bag containing 60 silver-coloured PET/Alu/LDPE sachets with the coated granules and one desiccant (labelled “DO NOT EAT” including pictogram and “SILICA GEL”).
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
EU/1/08/442/025
EU/1/08/442/026
EU/1/08/442/027
EU/1/08/442/028
EU/1/08/442/029
EU/1/08/442/030
Date of first authorisation: 18 March 2008
Date of latest renewal: 08 January 2018
| Drug | Countries | |
|---|---|---|
| PRADAXA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
