Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Ezetimibe 10mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to almost white, oval tablets (7.4 mm x 4.0 mm) with debossing “10” on one side and “EZT” on the other side. |
Each tablet contains 10 mg of ezetimibe.
Excipient with known effect: Each tablet contains 64.1 mg of lactose (as monohydrate).
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 |
|---|
|
Lactose monohydrate |
Alu/Alu blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets.
White HDPE container closed with white, tamper-evident polypropylene screw cap with mounted LDPE capsule with silica gel: 100 tablets and 250 tablets (for hospital use and dose dispensing pharmacies only).
Not all pack sizes may be marketed.
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
PL 04416/1387
Date of first authorisation: 21 Jan 2014
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