Skip to main content

HA479

Product Details
WHO Product ID
HA479
Status
Prequalified
INN, dosage form and strength
Ceftriaxone (sodium) Powder for solution for injection 1000mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Applicant organization
Egyptian International Pharmaceutical Industries
PO Box 149
10th of Ramadan City,
Egypt
Packaging details and storage conditions
Packaging Type
Vial, Glass Type II
Configuration
1x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Fresenius Kabi IPSUM S.R.L.
Via San Leonardo 23
Villadose,
Rovigo
45010
Italy
Ceftriaxone
FPP Manufacturing Site(s)
Egyptian International Pharmaceutical Industries
Cephalosporin Block, Industrial Area B1
10th of Ramadan City,
Egypt
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

.