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TB354

Product Details
WHO Product ID
TB354
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
PT. Dankos Farma
Jalan Rawa Gatel Blok III S, Kavling 35-40, Kawasan industri, Pulogadung, Kec. Cakung
Kel. Jatinegara,
13930
Indonesia
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Zhejiang Langhua Pharmaceutical Co Ltd
No 7, Donghai 3rd Avenue, Zhejiang Provincial Chemical & Medical Materials Base Linhai Zone
Linhai City,
Zhejiang
317 016
China
Levofloxacin
FPP Manufacturing Site(s)
PT. Kalbe Farma Tbk.
Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang
Bekasi,
17550
Indonesia
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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