CREVASTIN 10 Film Coated Tablet 10 mg

País: Tanzania

Idioma: inglés

Fuente: Tanzania Medicinces & Medical Devices Authority

Ingredientes activos:

Rosuvastatin

Disponible desde:

Bilim Ilac Sanayi ve Ticaret Anonim Sirketi, TURKEY

Código ATC:

Lipid modifying agents, plain, HMG CoA reductase

Designación común internacional (DCI):

Rosuvastatin

Dosis:

10 mg

formulario farmacéutico:

Film Coated Tablet

Fabricado por:

Bilim Ilac Sanayii ve Ticaret A.S, TURKEY

Resumen del producto:

Physical description: Pink-pinkish coloured, one side is written “10”, round, biconvex film coated tablet; Local technical representative: Tridem Pharma Tanzania Limited (69513)

Estado de Autorización:

Registered/Compliant

Fecha de autorización:

2022-01-10

Ficha técnica

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 CREVASTIN 10 (ROSUVASTATIN CALCIUM
EQUİVALENT
TO ROSUVASTATIN 10 MG) FILM COATED TABLETS
VERSION NUMBER 1
05 JANUARY, 2022
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.
INTRODUCTION
CREVASTIN 10 is a generic medicine of Crestor 10 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. CREVASTIN 10 is approved in Tanzania for use in adults,
adolescents, and
children patients aged 10 years or older.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0022
Brand name
CREVASTIN 10
Generic name, strength, and form
Each film coated tablet contains: Rosuvastatin Calcium
Equivalent to Rosuvastatin 10 mg
ATC classification
ATC code: C10A A07- HMG-CoA reductase inhibitors
Distribution category
POM
Country of origin
Turkey
Associated product
CREVASTIN 20 Film-Coated Tablets
Marketing Authorization Holder
Bilim İlaç San. ve Tic. A.Ş.
Kaptanpaşa
mah.
Zincirlikuyu
Cad.
No:
184
34440
Beyoğlu, İstanbul
Country: Turkey
E-Mail: [e-mail]
Local Technical Representative
Tridem Pharma Tanzania Limited
P.O. box 23145, Plot No 70, Keko Mwanga Dar es
sal