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EMA Art 58 H-W-2319-3

Product Details
WHO Product ID
EMA Art 58 H-W-2319-3
Status
Prequalified
INN, dosage form and strength
Artesunate/Pyronaridine (phosphate) Granules for Oral suspension 20mg/60mg
Basis of listing
Alternative Listing
Basis of alternative listing
EMA Article 58
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Granules for Oral suspension
Reference authority
European Medicines Agency
Applicant organization
Shin Poong Pharmaceutical Co Ltd
748-31 Yoksam-Dong, Gangnam-Gu
Seoul,
135-925
Republic of Korea
Packaging details and storage conditions
Packaging Type
Sachet, PE/Alu
Configuration
90x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
FPP Manufacturing Site(s)
Shin Poong Pharmaceutical Co Ltd
70, Sandan-ro, 19beon-gil, Danwon-Gu, Ansan-Si
Gyeonggi-do,
Republic of Korea

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