Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantASTRAZENECA 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
L04AA43
Manufacturer Information
ASTRAZENECA SINGAPORE PTE LTD
Catalent Indiana, LLC
Alexion Pharma International Operations Limited (AAMF)
Active Ingredients
Documents
Package Inserts
Ultomiris Approved PI.pdf
Approved: June 19, 2024