Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Adamed Sp. z o.o., Pieńków 149, 05-152 Czosnów, Poland
Ezehron Duo 20 mg/10 mg, tablet.
Ezehron Duo 10 mg/10 mg, tablet.
Ezehron Duo 5 mg/10 mg, tablet.
| Pharmaceutical Form |
|---|
|
Tablets. Ezehron Duo 20 mg/10 mg tablet: white to off-white, round, biconvex, uncoated tablet. The diameter of the tablet is 11 mm. Ezehron Duo 10 mg/10 mg tablet: white to off-white, oval, biconvex, uncoated tablet, engraved E1 on one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm. Ezehron Duo 5 mg/10 mg tablet: white to off-white, round, flat, uncoated tablet, engraved E2 on one side and 2 on the other side. The diameter of the tablet is 10 mm. |
Each tablet contains 20 mg rosuvastatin (as calcium salt) and 10 mg of ezetimibe.
Excipients of known activity: lactose monohydrate (each tablet contains 228.29 mg lactose monohydrate).
Each tablet contains 10 mg rosuvastatin (as calcium salt) and 10 mg of ezetimibe.
Excipients of known activity: lactose monohydrate (each tablet contains 238.39 mg lactose monohydrate).
Each tablet contains 5 mg rosuvastatin (as calcium salt) and 10 mg of ezetimibe.
Excipients of known activity: lactose monohydrate (each tablet contains 243.89 mg lactose 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. |
|
| Rosuvastatin |
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase. Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. |
| List of Excipients |
|---|
|
Lactose monohydrate |
Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 tablets in blister (PA/AL/PVC // Al). Not all pack sizes may be marketed.
Adamed Sp. z o.o., Pieńków 149, 05-152 Czosnów, Poland
Ezehron Duo 5 mg/10 mg, tablet MA948/00401
Ezehron Duo 10 mg/10 mg, tablet MA948/00402
Ezehron Duo 20 mg/10 mg, tablet MA948/00403
Date of first authorisation: 16th February 2018
| Drug | Countries | |
|---|---|---|
| EZEHRON DUO | Germany, Malta, Poland |
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