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EMA Art 58 H-W-764-2

Product Details
WHO Product ID
EMA Art 58 H-W-764-2
Status
Prequalified
INN, dosage form and strength
Lopinavir/Ritonavir Tablet, Film-coated 100mg/25mg
Basis of listing
Alternative Listing
Basis of alternative listing
EMA Article 58
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
60x1
Shelf life (months)
36
Storage conditions
Do not store above 30°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

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