Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay North Dock, D01 V4A3, Dublin 1, Ireland
Ezetrol 10 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white, capsule-shaped tablets, approximately 2.60 mm thick, debossed with “414” on one side. |
Each tablet contains 10 mg ezetimibe.
Excipient(s) with known effect:
Each tablet contains 55 mg of lactose monohydrate.
Ezetrol contains less than 1 mmol (23 mg) sodium per tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ezetimibe |
Ezetimibe is in a new class of lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol. The molecular target of ezetimibe is the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of cholesterol. |
| List of Excipients |
|---|
|
Croscarmellose sodium |
Unit Dose peelable blisters of clear polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium backed with paper and polyester in packs of 7, 10, 14, 20, 28, 30, 50, 98, 100, or 300 tablets.
Push‑through blisters of clear polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium in packs of 7, 10, 14, 20, 28, 30, 50, 84, 90, 98, 100, or 300 tablets.
Unit dose push‑through blisters of clear polychlorotrifluoroethylene/PVC coated aluminium in packs of 50, 100 or 300 tablets.
HDPE bottles with polypropylene cap, containing 100 tablets.
Not all pack sizes may be marketed.
Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay – North Dock, D01 V4A3, Dublin 1, Ireland
PA23198/023/001
Date of first authorisation: 25 July 2003
Date of last renewal: 17 October 2012
| Drug | Countries | |
|---|---|---|
| EZETROL | Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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