PRADAXA 110mg Hard capsule Ref.[7427] Active ingredients: Dabigatran

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany

Product name and form

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”.

Qualitative and quantitative composition

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
Acacia
Hypromellose
Dimeticone 350
Talc
Hydroxypropylcellulose

Capsule shell:

Carrageenan
Potassium chloride
Titanium dioxide
Indigo carmine (E132)
Hypromellose

Black printing ink:

Shellac
Iron oxide black (E172)
Potassium hydroxide

Pack sizes and marketing

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.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

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

Drugs

Drug Countries
PRADAXA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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