turbovas Tablets 20

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Rosuvastatin Calcium

Available from:

Micro Labs Limited, INDIA

ATC code:

Lipid modifying agents/ plain

INN (International Name):

Rosuvastatin Calcium

Dosage:

20

Pharmaceutical form:

Tablets

Manufactured by:

Micro Labs Limited, INDIA

Product summary:

Physical description: Orange coloured, Circular biconvex film coated tablets with MICRO engraved on one side and other plain on another surface; Local technical representative: Laborex Tanzania Limited (1124)

Authorization status:

Registered/Compliant

Authorization date:

2022-04-11

Summary of Product characteristics

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR TURBOVAS-20 (20 MG ROSUVASTATIN (AS
CALCIUM)) FILM COATED TABLETS
VERSION NUMBER 1.0
13 APRIL, 2022
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania
Tel: [phone]; Fax: [phone]
Email: [e-mail]; Website: mwww.tmda.go.tz
1.
INTRODUCTION
Turbovas-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. Turbovas-20 is approved in Tanzania for use in adults,
adolescents, and children aged
10 years or older.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0087
Brand name
Turbovas-20
Generic name, strength, and form
Each film coated tablet contains: Rosuvastatin Calcium
Equivalent to Rosuvastatin 20 mg
ATC classification
ATC code: C10A A07- HMG-CoA reductase inhibitors
Distribution category
POM
Country of origin
India
Associated product
Turbovas-10 Film-Coated Tablets
Marketing Authorization Holder
Micro Labs Limited
No.27,
Race
Course
Road,
Bangalore-560
001,
Karnataka
India
Local Technical Representative
Laborex Tanzania Limited
Plot: 89-90 Alliance Auto House
P.O. Box 70032,
Dar es Salaam
1.2 ASSESSMENT PROCEDURE
The application for registration of Turbovas-20 was submitted on 11
July 2019. The product
underwent full assessment. Assessment was completed in 3 (three)
rounds of evaluation and the
product was registered on 11 April 2022.
1.3 INFORMATION FOR USERS