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TB319

Product Details
WHO Product ID
TB319
Status
Prequalified
INN, dosage form and strength
Amikacin (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
Qilu Pharmaceutical Co.,Ltd
No. 23999 Gong Ye Bei Road,
Jinan,
Shandong
250100
China
Packaging details and storage conditions
Packaging Type
Ampoule, Type I glass 2ml
Configuration
10x1
Shelf life (months)
18
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shandong Anxin Pharmaceutical Co. Ltd.
No. 849 Dongjia Town, Licheng District
Jinan,
Shandong
250105
China
Amikacin (sulfate)
FPP Manufacturing Site(s)
Qilu Pharmaceutical Co., Ltd.
No. 317, Xinluo Road, High-tech Zone, Jinan
Shandong
250101
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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