Skip to main content

HP032

Product Details
WHO Product ID
HP032
Status
Prequalified
INN, dosage form and strength
Entecavir Tablet, Film-coated 1 mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Hepatitis B and C
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
United States Food and Drug Administration
Applicant organization
BrightGene Bio-Medical Technology Co., Ltd
Building C27, No. 218 Xinghu Road, Suzhou Industrial Park
Suzhou,
Jiangsu
215123
China
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
BrightGene Pharmaceutical Co., Ltd.
No. 218 Xinghu Road, Suzhou Industrial Park
Suzhou,
Jiangsu
China
Entecavir
FPP Manufacturing Site(s)
Visum Pharmaceuticals Co., Ltd.
273-D, Nanhai Boulevard
HaiKou,
570311
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 7

.