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HA381

Product Details
WHO Product ID
HA381
Status
Prequalified
INN, dosage form and strength
Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
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, HDPE
Configuration
120x1, 120x3
Shelf life (months)
48
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/Fluoropolymer/PVC
Configuration
8x5 per carton, 3 cartons per pack; 12x10
Shelf life (months)
36
Storage conditions
Do not store above 25°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 Deutschland GmbH and Co. KG
Knollstrasse 67061, Ludwigshafen
Germany
AbbVie LTD.
KM 58 Carretera, 2 Cruce Davilla, Barceloneta 00617
Puerto Rico
Fournier Laboratories Ireland Limited
Carrigtwohill business park, Anngrove, Carrigtwohill, Co. Cork
Ireland
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 7

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