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 of Great Britain and Northern Ireland
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
API Manufacturing Site(s)
By Organization
By Active Ingredient
Genentech Inc.
1000 New Horizons Way
Vacaville,
95688
United States of America
Rituximab
Genentech, Inc.
1 Antibody Way
Oceanside,
92056 5802
United States of America
Rituximab
Samsung BioLogics
300, Songdo Bio Way (Daero), Yeonsu-gu
Incheon,
21987
Republic of Korea
Rituximab
FPP Manufacturing Site(s)
Batch release site; Roche Pharma AG
Emil-Barell-Strasse 1
Grenzach-Wyhlen,
D-79639
Germany
