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EMA Art 58 H-W-2319-2

Product Details
WHO Product ID
EMA Art 58 H-W-2319-2
Status
Prequalified
INN, dosage form and strength
Artesunate/Pyronaridine (phosphate) Tablet, Film-coated 60mg/180mg
Basis of listing
Alternative Listing
Basis of alternative listing
EMA Article 58
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
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
Blister, Alu/PVC/Alu/oPA
Configuration
9x10
Shelf life (months)
30
Storage conditions
Do not store above 30°C, protect from light
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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