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TB311

WHO Product ID
TB311
Status
Prequalified
INN, dosage form and strength
Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Getz Pharma Pvt Ltd
29-30/27 Korangi Industrial Area
Karachi,
74900
Pakistan
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
5x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Chromo Laboratories India Private Limited
Plot No. 43 & 44, Phase II, I.D.A, Pashamylaram, Patancheru Mandai, Sangareddy District
Telangana
502 307
India
Moxifloxacin (hydrochloride)
FPP Manufacturing Site(s)
Getz Pharma Pvt Ltd
29-30/27 Korangi Industrial Area
Karachi,
74900
Pakistan
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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