Medicines/finished pharmaceutical products

Reference Number: 
RH072 (a)

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Magnesium sulphate
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Solution for injection 500mg/ml (10ml)
Storage condition: 
Do not store above 30°C
Shelf life (months): 
60
Packaging: 
Ampoule, Type I glass, colourless 10mlx50
Applicant: 
Labesfal, Laboratorios Almiro SA, Unit 2, Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157, Portugal
FPP Manufacturing Site: 

Labesfal, Laboratorios Almiro SA, Unit 2, Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157, Portugal

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Magnesium sulphate) K+S KALI GmbH, Werk Werra, Hattorfer Strasse, 36269, Philippsthal (Werra),Germany
Macco Organiques, S.R.O, Zahradni 1938/46c, Bruntál, 792 01, Czech Republic

API WHO Public Inspection Reports: