Product Details
WHO Product ID
BT-ON012
Status
Prequalified
INN, dosage form and strength
Rituximab Concentrate for solution for infusion 500mg/50mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Concentrate for solution for infusion
Applicant organization
Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park
Welwyn Garden City,
AL7 1TW
United Kingdom
Packaging details and storage conditions
Packaging Type
Vial, Type I glass 50 ml
Configuration
1x1 hydrolytic type I flint tubing glass vial
Shelf life (months)
36
Storage conditions
Store in a refrigerator (2 °C to 8 °C), protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Genentech Inc.
1000 New Horizons Way
Vacaville,
95688
United States
Rituximab
Genentech, Inc.
1 Antibody Way
Oceanside,
92056 5802
United States
Rituximab
Samsung BioLogics
300, Songdo Bio Way (Daero), Yeonsu-gu
Incheon,
21987
Korea, Rep.
Rituximab
FPP Manufacturing Site(s)
Batch release site; Roche Pharma AG
Emil-Barell-Strasse 1
Grenzach-Wyhlen,
D-79639
Germany