Glumac Tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Artemether , Lumefantrine

Available from:

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, CHINA

INN (International Name):

Artemether + Lumefantrine

Dosage:

9

Pharmaceutical form:

Tablets

Manufactured by:

GUILIN PHARMACEUTICALS CO., LTD, CHINA

Product summary:

Physical description: Yellow capsule-shaped tablet, debossed with a score line on one side; Local technical representative: KITETO DISTRICT COUNCIL (5773)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

Effective date: 03/10/2022
_TMDA/DMC/MRE/F/016 _
_REV #:02_
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR GLUMAC (ARTEMETHER 80 MG AND
LUMEFANTRINE 480 MG) TABLETS
VERSION NUMBER 01
3
RD JANUARY, 2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX
1253, DODOMA – TANZANIA, TELEPHONE: [phone]/+255
(22)
2450512/2450751/2452108, EMAIL: [e-mail], Website:
WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1.
INTRODUCTION
Glumac
is
a
generic
medicine
of
Coartem.
Glumac
is
an
antimalarial
medicine
belonging to P01BF01 antiparasitic products, insecticides and
repellents, Antiprotozoal,
Antimalarials Artemisinin and derivatives, combinations group. Glumac
contains a fixed
combination of 2 antimalarial active ingredients, artemether, an
artemisinin derivative,
and lumefantrine. Both components are blood schizontocides. Glumac is
approved in
Tanzania for use in adults, children and elderly.
1.1 PRODUCT DETAILS
Registration number
_TAN 21 HM 0167 _
Brand name
_Glumac _
Generic
name,
strength
and
form
_Artemether 80 mg and Lumefantrine 1480 mg _
ATC classification
_P01BF01 - antiparasitic products, insecticides and _
_repellents, _
_Antiprotozoal, Antimalarials Artemisinin _
_and derivatives, combinations _
Distribution category
_POM _
Country of origin
_China _
Associated product
_Not Applicable _
Marketing Authorization Holder
_Shanghai Fosun Pharmaceutical Development Co., _
_Ltd. _
_Room 350, No. 25 Kangshi road, Kangqiao town, _
_Pudong New District (Kangqiao), Shanghai _
_China. _
Local
Technical
Representative
_Tridem Pharma Tanzania Limited _
1.2
ASSESSMENT PROCEDURE
The application for registration of _ Glumac_ was submitted on _
26/07/2020_. The product
underwent
_abridged _
_assessment_.
Assessment
was
completed
in
_four_
rounds
of
evaluation. _Glumac_ was registered on _29_
_th_
_ March, 2021_.
1.3
INFORMATION FOR USERS
Visual
description
of
the
finished
pro