Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
INTRAVENOUS, INTRAMUSCULAR
Medical Information
J01DD02
ceftazidime
Manufacturer Information
FRESENIUS KABI (SINGAPORE) PTE LTD
Labesfal – Laboratorios Almiro, S.A.
Hanmi Fine Chemical Co.Ltd (Sterile Anhydrous Sodium Carbonate)
Hanmi Fine Chemical Co.Ltd (Sterile Ceftazadime buffered with sodium carbonate)
Active Ingredients
Documents
Package Inserts
CEFTAZIDIME KABI Powder for Solution for Injection.pdf
Approved: August 25, 2016