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HA515

Product Details
WHO Product ID
HA515
Status
Prequalified
INN, dosage form and strength
Ganciclovir (sodium) Powder for solution for injection 500mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Applicant organization
Hainan Poly Pharma Co Ltd
Guilinyang Economic Development Area
Haikou,
Hainan
China
Packaging details and storage conditions
Packaging Type
Vial, Glass
Configuration
10x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hainan Poly Pharma Co Ltd
Guilinyang Economic Development Area
Haikou,
Hainan
571127
China
Ganciclovir
FPP Manufacturing Site(s)
Hainan Poly Pharma Co Ltd
Guilinyang Economic Development Area
Haikou,
Hainan
China
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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