CO-ANGINET 160/25 Tablets 160/25 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:
Valsartan , Hydrochlorothiazide
Available from:
United Pharmaceuticals Manufacturing Company Limited, JORDAN
ATC code:
Renin-angiotensin system agents acting on
INN (International Name):
Valsartan + Hydrochlorothiazide
Dosage:
160/25 mg
Pharmaceutical form:
Tablets
Manufactured by:
United Pharmaceutical Manufacturing Co. Limited, JORDAN
Product summary:
Physical description: Light brown caplet biconvex film coated tablets, embossed with T17 on one side & plain on the other side; Local technical representative: Wide Spectrum (T) Limited (5975)
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
CO-ANGINET
160/25
(VALSARTAN
160
MG/HYDROCHLOROTHIAZIDE 25 MG) FILM COATED TABLETS
VERSION NUMBER 1.0
10 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
1.
INTRODUCTION
Co-Anginet® 160/25 is a generic medicine of CoDiovan forte 160 mg/25
mg tablets, Novartis
Pharma GmbH. Fixed combination antihypertensive agents i.e. valsartan,
an angiotensin receptor
blocker (ARB), and hydrochlorothiazide, a thiazide diuretic.
Hydrochlorothiazide is a diuretic that
produces smooth muscle cell relaxation and volume depletion.
Hypokalaemia is a known side
effect of thiazide diuretic therapy. The addition of an ARB to a
thiazide diuretic has a potentially
synergistic effect on blood pressure reduction by blocking the actions
of angiotensin II at the AT1
receptor and
also
attenuates diuretic-induced hypokalaemia.
Co-Anginet®
is approved
in
Tanzania for use only in adult patients.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0145
Brand name
Co-Anginet® 160/25
Generic name, strength, and form
Each film-coated tablet contains Valsartan 160 mg and
Hydrochlorothiazide 25 mg
ATC classification
ATC Code- C09DA03 - Angiotensin II antagonists and
diuretics combinations
Distribution category
POM
Country of origin
Jordan
Associated product
Co-Anginet®80/12.5, Co-Anginet®160/12.5
Marketing Authorization Holder
United Pharmaceuticals Manufacturing Company Limited,
Al Rageem Sahab,
Amman-Jordan
E-mail: samar.amaireh@mspharma.com
Local Technical Representative
Wide Spectrum(Tanzania) limited
Sikukuu Str, Kariakoo, P.O BOX 90518
Dar-es-Salaam, Tanzania
E-mail:widespectrumtz@yahoo.com
1.2 ASSESSMENT PROCEDURE
The application for registration of Co-Anginet® 160/25 was submitted
on 05 July 2017. The
product underwent full assessment. Assessment was completed in 3
(three) rounds of evaluation
an
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