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HA098

Product Details
WHO Product ID
HA098
Status
Prequalified
INN, dosage form and strength
Lopinavir/Ritonavir Solution, Oral 80mg/mL/20mg/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 Deutschland GmbH and Co. KG
Knollstrasse 67061, Ludwigshafen
Germany
Packaging details and storage conditions
Packaging Type
Bottle PET
Configuration
60ml
Shelf life (months)
24
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
API Manufacturing Site(s)
By Organization
By Active Ingredient
AbbVie S.r.L
S.R. 148 Pontina, Km 52 snc
Campoverde di Aprilia (LT),
4011
Italy
Lopinavir, Ritonavir
FPP Manufacturing Site(s)
AbbVie Inc.
1 N Waukegan Road, IL 60064
North Chicago,
United States of America
UPS SCS B.V.
Marco Poloweg 22-24, 5928 LE Venlo
Netherlands
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. 

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 2 , Part 7

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