Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantNOVARTIS (SINGAPORE) PTE LTD
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SUBCUTANEOUS
Medical Information
R03DX05
omalizumab
Manufacturer Information
NOVARTIS (SINGAPORE) PTE LTD
Takeda Austria GmbH
Novartis Pharma Stein AG
DELPHARM DIJON - QUETIGNY
Active Ingredients
Documents
Package Inserts
Xolair PI.pdf
Approved: January 27, 2023