Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantEISAI (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
N06DX04
Manufacturer Information
EISAI (SINGAPORE) PTE. LTD.
Vetter Pharma-Fertigung GmbH & Co. KG
Biogen U.S. Corporation
Active Ingredients
Documents
Package Inserts
Leqembi final PI May 2025.pdf
Approved: May 2, 2025