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CV004

WHO Product ID
CV004
Status
Prequalified
INN, dosage form and strength
Dexamethasone phosphate (as sodium) Solution for injection 4mg/ml
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Applicant organization
Farmak JSC
63 Kyrylivska St.
Kyiv,
4080
Ukraine
Packaging details and storage conditions
Packaging Type
Ampoule, Type I glass
Configuration
5x1ml; 10x1ml
Shelf life (months)
24
Storage condition
Do not store above 25 °C. Protect from light. Do not freeze. Avoid excursions above 25 °C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Tianjin Tianyao Pharmaceuticals Co., Ltd
No.19 Xin Ye 9th Street, West area of Tianjin Economic-technological Development Area
Tianjin,
Tianjin
300462
China
Dexamethasone phosphate (as sodium)
FPP Manufacturing Site(s)
Farmak JSC
74 Kyrylivska St.
Kyiv,
4080
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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