Skip to main content

HA607

Product Details
WHO Product ID
HA607
Status
Prequalified
INN, dosage form and strength
Ondansetron (hydrochloride) Solution for injection 8mg/4mL
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
4mlx1, 4mlx5
Shelf life (months)
36
Storage conditions
Do not store above 25°C
Packaging Type
Ampoule, PP
Configuration
4mlx1, 4mlx5
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 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 7

.