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RH086

WHO Product ID
RH086
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
Joint-Stock Company Halychpharm
6/8, Opryshkivska Str., Lviv
79024
Ukraine
Packaging details and storage conditions
Packaging Type
Ampoule, glass
Configuration
5x2x10ml
Shelf life (months)
60
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)
Joint-Stock Company Halychpharm
6/8, Opryshkivska Str., Lviv
79024
Ukraine
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 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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