Product Details
WHO Product ID
MA108
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet 80mg/480mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Novartis Pharma AG
Lichtstrasse 35
Basel,
4002
Switzerland
Packaging details and storage conditions
Packaging Type
Blister, PVC/PE/PVdC
Configuration
6x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
KPC Pharmaceuticals Inc
Small Volume Injection Plant, Qigongli (W)
Kunming,
Yunnan
650 100
China
Artemether
Zhejiang Lyee Biotechnology Co Ltd
No. 69 Luoxin Road, The North Division, Economic Development Zone
Shengzhou,
Zhejiang
312 400
China
Lumefantrine
Zhejiang Medicine Co Ltd
98 East Dadao Road
Xinchang,
Zhejiang
312 500
China
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Novartis Saglik
Gida ve Tarim Urunleri San. Ve Tic. A.S., Yenişehir Mahallesi Ihlara Vadisi Sokak No. 2, Pendik
Istanbul,
TR 34912
Türkiye