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HA597

Product Details
WHO Product ID
HA597
Status
Prequalified
INN, dosage form and strength
Ondansetron (hydrochloride) Solution for injection 4mg/2mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Reference authority
National Organization for Medicines (EOF)
Applicant organization
Demo SA
21st Km National Road Athens-Lamia
Krioneri,
14568
Greece
Packaging details and storage conditions
Packaging Type
Ampoule, Glass
Configuration
2mlx5, 2mlx1
Shelf life (months)
36
Storage conditions
Do not store above 25°C
Packaging Type
Ampoule, PE
Configuration
2mlx5, 2mlx1
Shelf life (months)
36
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Dr Reddy's Laboratories Ltd
Unit IV, Plot No 9A, I.D.A, Jeedimetla
Hyderabad,
Andhra Pradesh
500 055
India
Ondansetron (hydrochloride)
FPP Manufacturing Site(s)
Demo SA
21st Km National Road Athens-Lamia
Krioneri,
14568
Greece
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 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 7

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