Product Details
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
Storage conditions
Do not store above 25°C, protect from light
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