ARTEFAN Uncoated Tablets 60/360
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
22-08-2022
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Active ingredient:
ARTEMETHER & LUMEFANTRINE TABLETS
Available from:
Ajanta Pharma Limited, INDIA
ATC code:
Antimalarials
INN (International Name):
ARTEMETHER & LUMEFANTRINE TABLETS
Dosage:
60/360
Pharmaceutical form:
Uncoated Tablets
Manufactured by:
AJANTA Pharma LIMITED, INDIA
Product summary:
Physical description: Yellow coloured, capsule shaped, biconvex uncoated tablets,with breakline on one side; Local technical representative: ASTRA PHARMA (T) Limited (4645)
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
ARTEFAN 60/360 (ARTEMETHER 60 MG AND
LUMEFANTRINE 360 MG) TABLETS
VERSION NUMBER 1.0
14 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
Artefan
60/360
is
a
generic
medicine of
innovator
product
Coartem®
(Novartis
Pharma,
Switzerland). Artefan 60/360 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 60/360 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 0118
Brand name
Artefan 60/360
Generic name, strength and form
Each uncoated tablet containing 60 mg artemether and
360 mg lumefantrine
ATC classification
Artemisinin and derivatives, combinations (P01BF01)
Distribution category
POM
Country of origin
India
Associated product
Artefan 80/480, Artefan 20/120
Marketing Authorization Holder
Ajanta Pharma Limited,
Ajanta House,
Charkop, Kandivli (West),
Mumbai - 400 067,
India.
E-Mail: info@ajantapharma.com
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 60/360 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
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