ARTEFAN 80/480 Uncoated Tablets

Страна: Танзания

Език: английски

Източник: Tanzania Medicinces & Medical Devices Authority

Активна съставка:

ARTEMETHER & LUMEFANTRINE TABLETS

Предлага се от:

Ajanta Pharma Limited, INDIA

АТС код:

Antimalarials

INN (Международно Name):

ARTEMETHER & LUMEFANTRINE TABLETS

дозиране:

80/480

Лекарствена форма:

Uncoated Tablets

Произведено от:

AJANTA Pharma LIMITED, INDIA

Каталог на резюме:

Physical description: Yellow coloured, capsule shaped, biconvex uncoated tablets with breakline on one side.; Local technical representative: ASTRA PHARMA (T) Limited (4645)

Статус Оторизация:

Registered/Compliant

Дата Оторизация:

2022-04-11

Данни за продукта

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR ARTEFAN 80/480 (ARTEMETHER 80 MG AND
LUMEFANTRINE 480 MG) TABLETS
VERSION NUMBER 1.0
14 APRIL, 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
Artefan
80/480
is
a
generic
medicine of
innovator
product
Coartem®
(Novartis
Pharma,
Switzerland). Artefan 80/480 contains a fixed combination of
artemether and lumefantrine in the
ratio of 1:6, which acts as an antimalarial against schizonts.
Artemether is a semisynthetic chiral
acetal derivative of artemisinin isolated from the plant Artemisia
annua. Lumefantrine is a racemic
mixture
of
a
synthetic
fluorene
derivative.
Like
other
antimalarials
(quinine,
mefloquine,
halofantrine), lumefantrine belongs to the aryl-amino-alcohol family.
Artefan 80/480 is approved
in Tanzania for use in children who weigh between 25 kg to less than
35 kg.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0119
Brand name
Artefan 80/480
Generic name, strength and form
Each uncoated tablet containing 80 mg artemether and
480 mg lumefantrine
ATC classification
Artemisinin and derivatives, combinations (P01BF01)
Distribution category
POM
Country of origin
India
Associated product
Artefan 60/360, Artefan 20/120
Marketing Authorization Holder
Ajanta Pharma Limited,
Ajanta House,
Charkop, Kandivli (West),
Mumbai - 400 067,
India.
E-Mail: [e-mail]
Local Technical Representative
Astra Pharma (T) Ltd
Plot no-12, Vingunguti Industrial Area,
Nyerere Road, opp: Pepsi tanzania Ltd,
Dar es Salaam, Tanzania
1.2 ASSESSMENT PROCEDURE
The application for registration of Artefan 80/480 was submitted on 10
June, 2021. The product
underwent abridged assessment. Assessment was completed in 2 (two)
rounds of evaluation and
the product was registered on 11 April, 2022.
1.3 INFORMATION FOR USERS
Visual description of the finished product
Yellow
colo