ATORVAS 10 Tablet, Film-coated

Երկիր: Տանզանիա

Լեզու: անգլերեն

Աղբյուրը: Tanzania Medicinces & Medical Devices Authority

Ակտիվ բաղադրիչ:

Atorvastatin

Հասանելի է:

The Madras Pharmaceuticals , INDIA

ATC կոդը:

Lipid modifying agents, HMG-CoA-reductase inhibito

INN (Միջազգային անվանումը):

Atorvastatin

Դոզան:

10

Դեղագործական ձեւ:

Tablet, Film-coated

Պատրաստված է:

THE MADRAS PHARMACEUTICALS, INDIA

Ապրանքի ամփոփագիր:

Physical description: White colored circular slightly biconvex film coated tablets and scored in the middle on one side; Local technical representative: Moraf Pharmaceuticals Limited (5668)

Լիազորման կարգավիճակը:

Registered/Compliant

Հաստատման ամսաթիվը:

2021-03-29

Ապրանքի հատկությունները

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR ATORVAS 10 (ATORVASTATIN CALCIUM 10 MG )
FILM COATED TABLETS
VERSION NUMBER 01
3
rd
January, 2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX
1253, DODOMA – TANZANIA, TELEPHONE: [phone]/+255
(22)
2450512/2450751/2452108, EMAIL: [e-mail], Website:
WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1
1.
INTRODUCTION
ATORVAS 10 is a generic medicine of Lipitor (Atorvastatin calcium 10
mg). ATORVAS
20 is a Lipid modifying agents medicine belonging to HMG-CoA-reductase
inhibitors
group. ATORVAS 10 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 10 is approved in Tanzania for use in adults, adolescents and
children