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HP030

WHO Product ID
HP030
Status
Prequalified
INN, dosage form and strength
Tenofovir disoproxil fumarate Tablet, Film-coated 300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Hepatitis B and C
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
Workshop No.303, 104, 101 and 102, No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd.
Workshop No 201, 16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
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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