Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379, Munich, Germany
Efient 10 mg film-coated tablets.
Efient 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Efient 10 mg: Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other. Efient 5 mg: Yellow and double-arrow shaped tablets, debossed with “5 MG” on one side and “4760” on the other. |
Efient 10 mg: Each tablet contains 10 mg prasugrel (as hydrochloride).
Excipient(s) with known effect: Each tablet contains 2.1 mg lactose.
Efient 5 mg: Each tablet contains 5 mg prasugrel (as hydrochloride).
Excipient(s) with known effect: Each tablet contains 2.7 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Prasugrel |
Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function can result in the reduction of the rate of cardiovascular events such as death, myocardial infarction, or stroke. |
| List of Excipients |
|---|
|
Tablet Core: Microcrystalline cellulose Film-Coat: Lactose monohydrate |
Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Not all pack sizes may be marketed.
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379, Munich, Germany
Efient 5 mg: EU/1/08/503/001 – 007, 015
Efient 10 mg: EU/1/08/503/008 – 014, 016
Date of first authorisation: 25 February 2009
Date of latest renewal: 13 November 2013
| Drug | Countries | |
|---|---|---|
| EFIENT | Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom, South Africa |
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