Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Atorvastatin
The Madras Pharmaceuticals , INDIA
Lipid modifying agents, HMG-CoA-reductase inhibito
Atorvastatin
20
Tablet, Film-coated
THE MADRAS PHARMACEUTICALS, INDIA
Physical description: Orange coloured circular slightly biconvexed film coated tablets and scored in the middle on one side; Local technical representative: Moraf Pharmaceuticals Limited (5668)
Registered/Compliant
2021-03-29
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 REV #:02 THEUNITEDREPUBLICOFTANZANIA MINISTRYOFHEALTH TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY PUBLIC ASSESSMENT REPORT FOR ATORVAS 20 (ATORVASTATIN CALCIUM 20 MG ) FILM COATED TABLETS VERSION NUMBER 1 3 rd January, 2023 TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA ROAD, P. O. BOX 1253, DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255 (22) 2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, Website: WWW.TMDA.GO.TZ Toll free: 0800110084 Effective date: 03/10/2022 1 1. INTRODUCTION ATORVAS 20 is a generic medicine of Lipitor (Atorvastatin calcium 20 mg). ATORVAS 20 is a Lipid modifying agents medicine belonging to HMG-CoA-reductase inhibitors group. ATORVAS 20 is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl- coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolised primarily through the receptor with high affinity to LDL (LDL receptor). Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. Atorvastatin reduces LDL production and the number of LDL particles. Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles. Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid-lowering medicinal products ATORVAS 20 is approved in Tanzania for use in adults, adolescents and children Prečítajte si celý dokument