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TB353

Product Details
WHO Product ID
TB353
Status
Prequalified
INN, dosage form and strength
Protionamide Tablet, Film-coated 250mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
LEKHIM Joint Stock Company
23, Shota Rustaveli street
Kyiv,
1033
Ukraine
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
10x5; 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store tablets in blisters in the provided carton in ord
API Manufacturing Site(s)
By Organization
By Active Ingredient
Pen Tsao Chemical & Pharmaceutical Industry Ltd
No 2 Teili Road, Wusong, Baoshan District
Yanghang Town,
Shanghai
200 940
China
Protionamide
FPP Manufacturing Site(s)
Technolog Private Joint Stock Company
8, Stara prorizna Street
Uman city,
20300
Ukraine
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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