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HA692

Product Details
WHO Product ID
HA692
Status
Prequalified
INN, dosage form and strength
Ceftriaxone (sodium) Powder for solution for injection 1g
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Reference authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Applicant organization
Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park
Welwyn Garden City,
AL7 1TW
United Kingdom
Packaging details and storage conditions
Packaging Type
Vial, Type I glass
Configuration
1x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
DSM Nutritional Products Ltd.
Zweigniederlassung Werk Sisseln, Hauptstrasse 4
Sisseln,
4334
Switzerland
Ceftriaxone
FPP Manufacturing Site(s)
F Hoffmann - La Roche Ltd
Wurmisweg
Kaiseraugst,
CH-4303
Switzerland
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 5 , Part 7

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