WHO Product ID
MA217
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet, Dispersible 2.5mg/30mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Novartis AG
Suurstoffi 14
Rotkreuz,
6343
Switzerland
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PVDC
Configuration
12x1
Shelf life (months)
24
Storage conditions
Do not Store above 30°C. Store in the original package to protect from moisture. Avoid excursion above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
KPC Pharmaceuticals Inc
Qigongli (W)
Kunming,
Yunnan
650 100
China
Artemether
Olon S.p.A
Via R. Lepetit 142
Garessio,
Cuneo
12075
Italy
Artemether
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lumefantrine
Zhejiang Lyee Biotechnology Co., Ltd.
No. 69 Luoxin Road The North Division, Economic Development Zone
Shengzhou,
Zhejiang
312400
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