Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantORIENT EUROPHARMA PTE LTD
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
INTRAVENOUS
Medical Information
L01FX22
Manufacturer Information
ORIENT EUROPHARMA PTE LTD
BSP Pharmaceuticals S.p.A.,(Bulk Production &Primary packager)
Active Ingredients
Documents
Package Inserts
ZYNLONTA PI.pdf
Approved: September 25, 2024