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TB392

Product Details
WHO Product ID
TB392
Status
Prequalified
INN, dosage form and strength
Isoniazid Tablet 300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Svizera Labs Pvt. Ltd.
Plot No D16/6 TTC Industrial Area, MIDC, Turbhe
Navi Mumbai,
400 703
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
28x24
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
Packaging Type
Polypropylene bag in HDPE jar
Configuration
1000x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
FPP Manufacturing Site(s)
Svizera Labs Pvt. Ltd.
Plot No D16/6 TTC Industrial Area, MIDC, Turbhe
Navi Mumbai,
400 703
India
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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