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HP035

WHO Product ID
HP035
Status
Prequalified
INN, dosage form and strength
Entecavir Tablet, Film-coated 0.5mg
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
RV Lifesciences Limited
Plot No. H-19, MIDC, Waluj
Aurangabad,
Maharashtra
431133
India
Packaging details and storage conditions
Packaging Type
Blisters, Alu/Alu
Configuration
3x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
Packaging Type
Bottle, HDPE
Configuration
30x1, 100x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
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)
RV Lifesciences Limited
Plot No. H-19, MIDC, Waluj
Aurangabad,
Maharashtra
431133
India
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 authorized 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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