METAPROL Film coated tablets 50 mg

Šalis: Tanzanija

kalba: anglų

Šaltinis: Tanzania Medicinces & Medical Devices Authority

Veiklioji medžiaga:

Metoprolol

Prieinama:

Lincoln Pharmaceuticals Limited, INDIA

ATC kodas:

Beta blocking agents, selective

INN (Tarptautinis Pavadinimas):

Metoprolol

Dozė:

50 mg

Vaisto forma:

Film coated tablets

Pagaminta:

Lincoln Parenteral Limited, INDIA

Produkto santrauka:

Physical description: White to off white coloured, round shaped, biconvex, plain on both sides, film coated tablets; Local technical representative: Heko Pharmacy Limited (7718)

Autorizacija statusas:

Registered/Compliant

Leidimo data:

2021-03-29

Prekės savybės

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR METAPROL (METOPROLOL TARTRATE 50
MG) FILM COATED TABLETS
VERSION NUMBER 0.1
MARCH, 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
Metaprol is a generic medicine of metoprolol tartrate. Metaprol is an
antihypertensive medicine
belonging to dihydropyridine group. Metaprol exerts is activity by
blocking beta-receptor sites
hence decreasing the blood pressure. Metaprol is approved in Tanzania
for use in .
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0121
Brand name
Metaprol
Generic name, strength and form
Metaprolol Tartrate 50 mg Tablets
ATC classification
C07AB02
Distribution category
POM
Country of origin
India
Associated product
Nil
Marketing Authorization Holder
Lincoln Pharmaceuticals Limited
Trimul Estate, Khatraj, Taluka: Kalol,
District: Gandhinagar Gujarat, India.
Local Technical Representative
Heko Pharmacy Ltd,
P. O. Box 2657,
Plot No.32/57, Sikukuu/Tandamti Street,
Kariakoo, Dar es Salaam
1.2 ASSESSMENT PROCEDURE
The
application
for
registration
of
Metaprol
was
submitted
on
05.03.2019.
The
product
underwent full assessment. Assessment was completed in three (3)
rounds of evaluation.
Metaprol was registered on 29/03/2021.
1.3 INFORMATION FOR USERS
Visual description of the finished product
White
to
off
white
coloured,
round
shaped,
biconvex, plain on both sides, film coated tablets
Primary packing material
Alu/PVDC blister pack of 5x10’s
Secondary packing materials
Carton box
Shelf-life and storage condition
Shelf life, Store below 30
0
C
Route of administration
Oral
Therapeutic indications
Indicated for management of hypertension (alone
or
in
Combination
with
other
Hypertensive
agents),
angina
Pectoris,
Cardiac
arrhythmias
especially;
Supraventricular
tachyarrhythmias,
Migraine
prophylaxis,
adjunct
to
treatment