Artesiane 100 Solution for injection
Country: Tanzania
Bahasa: Inggeris
Sumber: Tanzania Medicinces & Medical Devices Authority
Ciri produk
(SPC)
22-03-2023
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Bahan aktif:
Artemether
Boleh didapati daripada:
Dafra Pharma GmbH, SWITZERLAND
INN (Nama Antarabangsa):
Artemether
Dos:
100
Borang farmaseutikal:
Solution for injection
Dikeluarkan oleh:
Anfarm Hellas S.A, GREECE
Ringkasan produk:
Physical description: Clear, colourless to slightly yellowish oily; Local technical representative: Harleys (T) Limited (4194)
Status kebenaran:
Registered/Compliant
Tarikh kebenaran:
2022-04-13
Ciri produk
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
ARTESIANE® 100 (ARTEMETHER 100MG/ML) SOLUTION
FOR INJECTION
VERSION NUMBER 01, 06/01/2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX 1253,
DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255 (22)
2450512/2450751/2452108,
EMAIL: INFO@TMDA.OG.TZ, Website: WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1.
INTRODUCTION
ARTESIANE® 100 is an antimalarial drug of the artemisinin family.
The antimalarial activity of
Artemether
and
its
active
metabolite
dihydroartemisinin
(DHA)
has
been
attributed
to
endoperoxide moiety. The presence of the endoperoxide bridge
(generating singlet oxygen and
free
radicals)
appears to be
essential for the
antimalarial
activity.
ARTESIANE®
100
is
approved in Tanzania for use in children and adult patients.
1.1 PRODUCT DETAILS
Registration number
TAN 22 HM 0137
Brand name
ARTESIANE® 100
Generic name, strength and form
Each ampoule (1 ml) contains 100 mg artemether
ATC classification
ATC
code:
P01BE02-
Antimalarials,
Artemisinin
and
derivatives, plain.
Distribution category
POM
Country of origin
India
Associated product
ARTESIANE®
80,
ARTESIANE®
300,
and
ARTESIANE® 20
Marketing Authorization Holder
Dafra Pharma GmbH
Muhlenberg 7, 4052 Basel
Switzerland
E-mail: regulatory@defra.be
Local Technical Representative
Harleys (T) Limited,
P.O. Box 12589,
Dar es Salaam.
Email: tahir.muhammad@harleysltd.com
1.2 ASSESSMENT PROCEDURE
The application for registration of ARTESIANE® 100 was submitted on
23 November, 2020.
The product underwent full assessment. Assessment was completed in 2
(two) rounds of
evaluation and the product was registered on 20/08/2021.
1.3 INFORMATION FOR USERS
Visual description of the finished product
Clear, colourless to slightly yellow oily solution
Primary packing material
Ph. Eur. Type I glass ampoule
Secondary packing ma
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