AMLOVIE 10 Tablets 10 mg
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
22-08-2022
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Active ingredient:
Amlodipine
Available from:
Dafra Pharma GmbH, SWITZERLAND
ATC code:
Selective calcium channel blockers with mainly vas
INN (International Name):
Amlodipine
Dosage:
10 mg
Pharmaceutical form:
Tablets
Manufactured by:
Bluepharma Industria Farmaceutica S.A,, PORTUGAL
Product summary:
Physical description: White to almost white tablets of oblong shape with halving score on one side; Local technical representative: JD PHARMACY LIMITED (6943)
Authorization status:
Registered/Compliant
Authorization date:
2021-06-03
Summary of Product characteristics
TMDA/DMC/MRE/F/016
Revision#
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR AMLOVIE 10 (AMLODIPINE 10MG)
TABLETS
VERSION NUMBER 1.0
14
TH APRIL, 2022
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania
Tel: +255-22-2450512/2450751/ 2452108; Fax: +255-22-2450793
Email: info@tmda.go.tz; Website: mwww.tmda.go.tz
TANZANIA PUBLIC
ASSESSMENT REPORT
_TMDA/DMC/MRE/F/016 _
_REV #:_
1.
INTRODUCTION
Amlovie
10
is
a
generic
medicine
of
Novartis®
10 mg Tablets
Amlovie
10
is
a
antihypertensives
medicine
belonging
to
Selective
Calcium
channel
blockers,
dihydropyridine derivative group. Amlodipine is a calcium ion influx
inhibitor of the
dihydropyridine group (slow channel blocker or calcium ion antagonist)
and inhibits the
transmembrane influx of calcium ions into cardiac and vascular smooth
muscle. The
mechanism of the antihypertensive action of amlodipine is due to a
direct relaxant effect
on vascular smooth muscle. The precise mechanism by which amlodipine
relieves angina
has not been fully determined but amlodipine reduces total ischaemic
burden by the
following two actions. Amlodipine dilates peripheral arterioles and
thus, reduces the total
peripheral resistance (afterload) against which the heart works. Since
the heart rate
remains stable, this unloading of the heart reduces myocardial energy
consumption and
oxygen requirements. Amlovie 10 is approved in Tanzania for use in
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