Source: Medicines Authority (MT) Revision Year: 2022 Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Ezoleta 10 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Tablets are presented as white to off white, capsule shaped tablets with beveled edges. Tablet dimensions: 8 × 4 mm. |
Each tablet contains 10 mg ezetimibe.
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 |
|---|
|
Sodium laurilsulfate |
Blister (OPA/Alu/PVC//Alu): 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets, in a box.
Blister (perforated unit dose blisters, OPA/Alu/PVC//Alu): 14 × 1, 28 × 1, 30 × 1, 50 × 1, 56 × 1, 60 × 1, 90 × 1, 98 × 1, 100 × 1 tablet, in a box.
Not all pack sizes may be marketed.
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
MA982/01901
Date of first authorisation: 03.06.2020
Renewal of the authorisation: 02.09.2022
| Drug | Countries | |
|---|---|---|
| EZOLETA | Estonia, Hong Kong, Croatia, Lithuania, Malta, Poland, Romania |
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