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TB378

Product Details
WHO Product ID
TB378
Status
Prequalified
INN, dosage form and strength
Levofloxacin Tablet, Film-coated 500mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd
333 Jiangnan Road, Hengdian
Dongyang,
Zhejiang
322 118
China
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
4x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd
333 Jiangnan Road, Hengdian
Dongyang,
Zhejiang
322 118
China
Levofloxacin
FPP Manufacturing Site(s)
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd
333, Second Jiangnan Road, Hengdian
Dongyang,
Zhejiang
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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