Lariact Dispersible Tablets 20 + 120 mg
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
12-09-2022
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Active ingredient:
Artemether , Lumefantrine
Available from:
S Kant Healthcare Limited, INDIA
ATC code:
Antimalarials
INN (International Name):
Artemether + Lumefantrine
Dosage:
20 + 120 mg
Pharmaceutical form:
Tablets
Manufactured by:
S Kant Healthcare Limited, INDIA
Product summary:
Physical description: Yellow coloured, circular, uncoated flat beveled edges tablets, plain on both sides.; Local technical representative: Abacus Pharma Africa Limited (8473)
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
LARIACT
(ARTMETHER
20
MG
AND
LUMEFANTRINE 120 MG) DISPERSIBLE TABLETS
VERSION NUMBER 1.0
12 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
Lariact Dispersible is a generic medicine of innovator product
Coartem® Dispersible (Novartis
Pharma, Switzerland). Lariact Dispersible 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. Lariact
Dispersible is approved in Tanzania for use in adults, children and
infants of 5 kg and above.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0081
Brand name
Lariact Dispersible
Generic name, strength and form
Each dispersible tablet containing 20 mg artemether and
120 mg lumefantrine
ATC classification
Artemisinin and derivatives, combinations (P01BF01)
Distribution category
POM
Country of origin
India
Associated product
Lariact 20 mg/120 mg, Lariact Forte, Lariact DS, Lariact
180 mg/1080 mg
Marketing Authorization Holder
Abacus Pharma (A) Limited
Plot No. 18C, Nyerere Road
PO Box 12294,
Dar es Salaam.
Local Technical Representative
N/A
1.2 ASSESSMENT PROCEDURE
The application for registration of Lariact Dispersible was submitted
on 30 December, 2016. The
product underwent full assessment. Assessment was completed in 7
(seven) rounds of evaluation
and the product was registered on 11 April, 2022.
1.3 INFORMATION FOR USERS
Visual description of the finished product
Yellow coloured, circular, uncoated flat beveled
edges tablet, plain on both sides
Pr
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