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TB317

Product Details
WHO Product ID
TB317
Status
Prequalified
INN, dosage form and strength
Kanamycin (sulfate) Solution for injection 500mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Applicant organization
Shanghai Harvest Pharmaceutical Co., Ltd
No. 805, Jinhu Road, Pudong New Area
Shanghai,
Shanghai
201206
China
Packaging details and storage conditions
Packaging Type
Ampoule, type I glass
Configuration
10x2ml
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd
No. 8 Nangang Road, Jiangyin Industrial Concentration Zone
Fuqing, Fuzhou city,
Fujian
350309
China
Kanamycin (sulfate) - non sterile
FPP Manufacturing Site(s)
Shanghai Harvest Pharmaceutical Co., Ltd
No. 805, Jinhu Road, Pudong New Area
Shanghai,
Shanghai
201206
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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