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RH072

WHO Product ID
RH072
Status
Prequalified
INN, dosage form and strength
Magnesium sulphate Solution for injection 500mg/ml (10ml)
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Reference authority
INFARMED IP
Applicant organization
Labesfal, Laboratorios Almiro SA
Unit 2, Zona Industrial do Lagedo
Santiago de Besteiros,
3465-157
Portugal
Packaging details and storage conditions
Packaging Type
Ampoule, Type I glass, colourless
Configuration
10mlx50
Shelf life (months)
60
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
K+S KALI GmbH
Werk Werra, Standort Hattorf, Hattorfer Strasse, 36269
Philippsthal (Werra),
Germany
Magnesium sulphate
Macco Organiques, S.R.O
Zahradni 1938/46c
Bruntál,
792 01
Czechia
FPP Manufacturing Site(s)
Labesfal, Laboratorios Almiro SA
Unit 2, Zona Industrial do Lagedo
Santiago de Besteiros,
3465-157
Portugal
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

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

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