Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bristol-Myers Squibb/Pfizer EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Eliquis 0.15 mg granules in capsules for opening.
| Pharmaceutical Form |
|---|
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Granules in capsules for opening. The granules are white to off white in colour. They are provided in a hard capsule with a clear body and yellow opaque cap, which must be opened prior to administration. |
Each capsule contains 0.15 mg apixaban.
Excipient(s) with known effect: Each capsule of 0.15 mg contains up to 124 mg of sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Apixaban |
Apixaban is a potent, oral, reversible, direct and highly selective active site inhibitor of factor Xa. It does not require antithrombin III for antithrombotic activity. Apixaban inhibits free and clot-bound factor Xa, and prothrombinase activity. By inhibiting factor Xa, apixaban prevents thrombin generation and thrombus development. |
| List of Excipients |
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Granules content: Hypromellose (E464) Gelatin (E441): Titanium dioxide (E171) Black printing ink: Shellac (E904) |
High-density polyethylene (HDPE) bottle with a foil induction seal and a child-resistant polypropylene cap packed into a carton.
Each bottle contains 28 capsules for opening.
Bristol-Myers Squibb/Pfizer EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/11/691/016
Date of first authorisation: 18 May 2011
Date of latest renewal: 11 January 2021
| Drug | Countries | |
|---|---|---|
| ELIQUIS | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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