Product Details
WHO Product ID
BT-ON009
Status
Prequalified
INN, dosage form and strength
Trastuzumab Powder for concentrate for solution for infusion 150mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Powder for 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, 15 mL clear glass type I flint tubing glass
Configuration
1x1
Shelf life (months)
48
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
FPP Manufacturing Site(s)
Batch release site; Roche Pharma AG
Emil-Barell-Strasse 1
Grenzach-Wyhlen,
D-79639
Germany
F. Hoffmann-La Roche Ltd
Basel,
CH-4070
Switzerland
Genentech, Inc.
4625 NE Brookwood Parkway
Hillsboro,
97124 9332
United States
Patheon Manufacturing Services LLC
5900 Martin Luther King Jr. Hwy, P.O. Box 1887, Greenville
NC 27834
United States
Roche Diagnostics GmbH
Sandhofer Strasse 116 D
Mannheim,
68305
Germany