WHO Product ID
EMA Art 58 H-W-002168
Status
Prequalified
INN, dosage form and strength
Dapivirine Vaginal ring 25mg
Basis of listing
Alternative Listing
Basis of alternative listing
EMA Article 58
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Vaginal ring
Applicant organization
International Partnership for Microbicides Belgium (IPM Belgium) AISBL
Square de Meeûs 38/40
Brussels,
1000
Belgium
Packaging details and storage conditions
Packaging Type
Pouch, Opaque metalized polyester
Configuration
1x1, 3x1
Shelf life (months)
48
API Manufacturing Site(s)
By Organization
By Active Ingredient
S.A. Ajinomoto OmniChem n.v.
OmniChem Division, Cooppallaan 91
Wetteren,
B-9230
Belgium
Dapivirine
FPP Manufacturing Site(s)
QPharma AB
Agneslundsvägen 27
Malmö,
Sweden