Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Pradaxa 110 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Capsules with light blue, opaque cap and light blue, opaque body of size 1 (approx. 19 × 7 mm) filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”. |
Each hard capsule contains 110 mg of 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 |
|---|
|
Capsule content: Tartaric acid Capsule shell: Carrageenan Black printing ink: Shellac |
Perforated aluminium unit dose blisters of 10 × 1 hard capsules. Each carton contains 10, 30 or 60 hard capsules.
Multipack containing 3 packs of 60 × 1 hard capsules (180 hard capsules). Each individual pack of the multipack contains 6 perforated aluminium unit dose blisters of 10 × 1 hard capsules.
Multipack containing 2 packs of 50 × 1 hard capsules (100 hard capsules). Each individual pack of the multipack contains 5 perforated aluminium unit dose blisters of 10 × 1 hard capsules.
Perforated aluminium unit dose white blisters of 10 × 1 hard capsules. Each carton contains 60 hard capsules.
Polypropylene bottle with a screw cap containing 60 hard capsules.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
EU/1/08/442/005
EU/1/08/442/006
EU/1/08/442/007
EU/1/08/442/008
EU/1/08/442/014
EU/1/08/442/015
EU/1/08/442/018
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 |
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