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TB364

Product Details
WHO Product ID
TB364
Status
Prequalified
INN, dosage form and strength
Clofazimine Capsules, soft 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Capsules, soft
Applicant organization
Dong-A ST Co Ltd
64, Cheonho-daero, Dongdaemun-gu
Seoul,
130 708
Korea, Rep.
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
100x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
ST Pharm Co Ltd
Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si
15086
Republic of Korea
Clofazimine
FPP Manufacturing Site(s)
Dong-A ST Co Ltd
2F SectionB, 3F, 4F SectionB, 200-23. Baekseokgongdan 1-ro,, Seobuk-gu
Cheonan-si,
31093
Korea, Rep.
Suheung Co. Ltd
Osong Plant (Head Office), 61, Osongsaengmyeong-ro, Osong-eup, Heungdeok-gu, Ceongjusi,
Chungcheongbuk-do,,
Korea, Rep.
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (included 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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