AURITZ 20 Film Coated Tablet 20mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Rosuvastatin

Available from:

Mega Lifesciences Public Company Limited, THAILAND

ATC code:

Lipid modifying agents, plain, HMG CoA reductase

INN (International Name):

Rosuvastatin

Dosage:

20mg

Pharmaceutical form:

Film Coated Tablet

Manufactured by:

Inventia Healthcare Limited, INDIA

Product summary:

Physical description: Pink , round , biconvex , coated tablet debossed “063” on one side and plain on other side; Local technical representative: MEGA WECARE TANZANIA LIMITED (72635)

Authorization status:

Registered/Compliant

Authorization date:

2022-09-21

Summary of Product characteristics

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR AURITZ 20 (ROSUVASTATIN CALCIUM
EQUIVALENT TO ROSUVASTATIN 20 MG) FILM- COATED TABLETS
VERSION NUMBER 01, 06/01/2023
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
Auritz 20 is a generic medicine of Crestor 20 mg film- coated tablets
of Astra Zeneca is
a blood cholesterol-lowering drug of statin family. Rosuvastatin is a
selective and
competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme
that converts 3-
hydroxy-3- methylglutaryl coenzyme A to mevalonate, a precursor for
cholesterol. The
primary site of action of Rosuvastatin is the liver, the target organ
for cholesterol
lowering. 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.
Auritz 20 is approved in Tanzania for treatment of Treatment of
hypercholesterolaemia
in adults, adolescents and children aged 6 or older with primary
hypercholesterolaemia
and prevention of cardiovascular events.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0413
Brand name
Auritz 20
Generic
name,
strength
and
form
Each
film-coated
tablet
contains
20
mg
of
rosuvastatin as 20.8 mg of rosuvastatin calcium
ATC classification
HMG-CoA
reductase
inhibitors
ATC
code:
C10A
A07
Distribution category
POM
Country of origin
India
Associated product
The finished product is presented as a film-coated
tablet containing 10 mg & 20 mg of rosuvastatin
calcium as active substance
Marketing Authorization Holder
Mega Lifesciences Public Company Limited.
384
Soi
6,
Pattana
3
Road,Bangpoo