Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantROCHE SINGAPORE PTE. LTD.
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INFUSION, SOLUTION CONCENTRATE
INTRAVENOUS
Medical Information
L01FX28
glofitamab
Manufacturer Information
ROCHE SINGAPORE PTE. LTD.
Genentech, Inc. (Bulk production and primary packing)
Active Ingredients
Documents
Package Inserts
Columvi Concentrate for Solution for Infusion PI.pdf
Approved: March 5, 2024