Product Details
WHO Product ID
BT-ON006
Status
Prequalified
INN, dosage form and strength
Rituximab Concentrate for solution for infusion 100mg/10mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Concentrate for solution for infusion
Applicant organization
Sandoz GmbH
Biochemiestrasse 10
Langkampfen,
6336
Austria
Packaging details and storage conditions
Packaging Type
Vials, 10 mL clear type I glass
Configuration
2 or 3 x1
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
Boehringer Ingelheim Pharma GmbH & Co. KG
Birkendorfer Straße 65
Biberach an der Riss,
88397
Germany
Rituximab
Novartis Manufacturing GmbH
Emil-von-Behring-Straße 76
Marburg,
35041
Germany
Rituximab
Sandoz GmbH
Biochemiestrasse 10
Langkampfen,
6336
Austria
Rituximab
FPP Manufacturing Site(s)
Batch release site; Lek Pharmaceuticals d.d.
Verovškova 57
Ljubljana,
1526
Slovenia
Batch release site; Sandoz GmbH
Biochemiestrasse 10
Langkampfen,
6336
Austria