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RH064

Product Details
WHO Product ID
RH064
Status
Prequalified
INN, dosage form and strength
Magnesium sulphate Solution for injection 500mg/ml (10ml)
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Applicant organization
AS KALCEKS
Krustpils iela 71E
Riga,
LV-1057
Latvia
Packaging details and storage conditions
Packaging Type
Ampoule, Type I glass
Configuration
10mlx5, 10mlx10, 10mlx100
Shelf life (months)
60
Storage conditions
Do not store above 30°C. Do not freeze
API Manufacturing Site(s)
By Organization
By Active Ingredient
Macco Organiques, S.R.O
Zahradni 1938/46c
Bruntál,
792 01
Czechia
Magnesium sulphate
FPP Manufacturing Site(s)
HBM Pharma s.r.o.
Sklabinska 30
Martin,
036 80
Slovakia
Mefar Ilac Sanayii A.S.
Ramazanoglu Mah. Ensar Cad. No: 20
Kurtkoy-Pendik,
İstanbul
TR-34906
Türkiye
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

 

Part 1 , Part 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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