NICARDIA RETARD 20 Extended Release Tablet 20 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Nifedipine

Available from:

Unique Pharmaceutical Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd), INDIA

ATC code:

Selective calcium channel blockers with mainly vas

INN (International Name):

Nifedipine

Dosage:

20 mg

Pharmaceutical form:

Extended Release Tablet

Manufactured by:

Unique Pharmaceutical Laboratories (A Division of J.B Chemicals and Pharmaceutical Limited), INDIA

Product summary:

Physical description: Orange colored film coated biconvex round tablets with one side scored; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Authorization status:

Registered/Compliant

Authorization date:

2022-07-19

Summary of Product characteristics

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR NICARDIA RETARD 20 (NIFEDIPINE 20 MG)
EXTENDED-RELEASE TABLETS
VERSION NUMBER 01,
05/01/2023
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
Nicardia Retard 20 is a calcium antagonist of the 1,4-dihydropyridine
type. Calcium
antagonists reduce the transmembranal influx of calcium ions through
the slow calcium
channel into the cell. As a specific and potent calcium antagonist,
nifedipine acts
particularly on the cells of the myocardium and the smooth muscle
cells of the coronary
arteries and the peripheral resistance vessels. The main action of
nifedipine is to relax
arterial smooth muscle, both in the coronary and peripheral
circulation. The Nicardia
Retard 20 tablet is formulated to achieve controlled delivery of
nifedipine in a release
profile sufficient to enable once-daily administration to be effective
in clinical use.
This application concerns a generic application claiming essential
similarity with the
innovator
product
Adalat
LA
20
mg
prolonged-release
tablets,
containing
20
mg
nifedipine, which have been registered in the Netherlands by Bayer
B.V. since 24
October 1991.
Nicardia
Retard
20
is
approved
in
Tanzania
for
the
treatment
of
all
grades
of
hypertension in adult and for the prophylaxis of chronic stable angina
pectoris either as
monotherapy or in combination with a beta-blocker.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0320
Brand name
Nicardia Retard 20
Generic
name,
strength
and
form
Nifedipine
ATC classification
ATC code: C08CA05
Selective
calcium
channel
blockers
with
mainly
vascular effect, dihydropyridine derivatives
Distribution category
POM
Country of origin
India