Medicines/finished pharmaceutical products

Reference Number: 
RH063

Date of prequalification: 
04 July 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Magnesium sulfate
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Solution for injection 500mg/ml (2ml)
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Ampoule;Type I glass 2mlx10, 2mlx100
Applicant: 
AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia
FPP Manufacturing Site: 

HBM Pharma sro, Sklabinska 30, Martin, 036 80, Slovakia

API Manufacturing Site: 

(Magnesium sulfate heptahydrate) K+S KALI GmbH, Werk Werra, Hattorfer Strasse, 36269, Philippsthal (Werra),Germany

API WHO Public Inspection Reports: