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HP003

Product Details
WHO Product ID
HP003
Status
Prequalified
INN, dosage form and strength
Sofosbuvir Tablet, Film-coated 400mg
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
European Egyptian Pharmaceuticals Industries Co
PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya
Alexandria,
Egypt
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
28x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in dry condition
API Manufacturing Site(s)
By Organization
By Active Ingredient
CAD Middle East Pharmaceutical Industries LLC.
King Khalid, International Airport, Industrial District, P.O. Box: 26721
Riyadh,
11496
Saudi Arabia
Sofosbuvir
FPP Manufacturing Site(s)
European Egyptian Pharmaceuticals Industries Co
PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya
Alexandria,
Egypt
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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