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HA096

Product Details
WHO Product ID
HA096
Status
Prequalified
INN, dosage form and strength
Ritonavir Solution, Oral 80mg/mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution, Oral
Reference authority
European Medicines Agency
Applicant organization
AbbVie Ltd
AbbVie House, Vanwall Road
Maidenhead,
SL6 4UB
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Bottle, PET
Configuration
90mlx1
Shelf life (months)
6
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
AbbVie S.r.L
S.R. 148 Pontina, Km 52 snc
Campoverde di Aprilia (LT),
4011
Italy
FPP Manufacturing Site(s)
Aesica Queenborough Limited
North Road
Queenborough,
ME11 5EL
United Kingdom
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 7

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