Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
TWICOR 10 mg/10 mg film-coated tablets.
TWICOR 20 mg/10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. TWICOR 10 mg/10 mg film-coated tablets: Pink coloured round shaped film-coated tablet with a diameter of 10.1 mm embossed with “AL” on one side. TWICOR 20 mg/10 mg film-coated tablets: Pink coloured round shaped film-coated tablet with a diameter of 10.7 mm, plain on both sides. |
TWICOR 10 mg/10 mg film-coated tablets: Each film-coated tablet contains 10 mg of rosuvastatin (as calcium) and 10 mg of ezetimibe.
TWICOR 20 mg/10 mg film-coated tablets: Each film-coated tablet contains 20 mg of rosuvastatin (as calcium) and 10 mg of 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. |
|
| 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 |
|---|
|
Rosuvastatin – Core: Starch, pregelatinised (maize) Ezetimibe – Core: Mannitol (E421) Tablet coating: Hypromellose (E464) |
TWICOR 10 mg/10 mg and 20 mg/10 mg film-coated tablets.
OPA/Al/PVC-Al blister packs.
Packs of 10, 30, 60, 90 film-coated tablets.
Not all pack sizes may be marketed.
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
TWICOR 10mg/10mg film-coated tablets MA1507/02501
TWICOR 20mg/10mg film-coated tablets MA1507/02502
Date of first authorisation: 26/10/2018
Renewal of the Authorisation: 24/08/2022
| Drug | Countries | |
|---|---|---|
| TWICOR | Spain, France, Malta, Romania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
