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HA774

Product Details
WHO Product ID
HA774
Status
Prequalified
INN, dosage form and strength
Sulfamethoxazole/Trimethoprim Tablet 400 mg/80 mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Shouguang Fukang Pharmaceutical Co., Ltd.
No. 666 Dongwaihuan Road
Shouguang City,
Shandong
262700
China
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from moisture
Packaging Type
Blister, Alu/PVC
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Store tablets in the blisters in the provided carton in
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shouguang Fukang Pharmaceuticals Co. Ltd.
North-East of Dongwaihuan Road, Dongcheng Industrial Area
Shouguang City, Shandong Province,
262 700
China
Sulfamethoxazole, Trimethoprim
FPP Manufacturing Site(s)
Shouguang Fukang Pharmaceutical Co., Ltd.
Site 2, workshop 601 and Warehouse C09, Wensheng East Street No. 999
Shouguang,
Shandong
262700
China
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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