Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantBAYER (SOUTH EAST ASIA) PTE LTD
Licence HolderBAYER (SOUTH EAST ASIA) PTE LTD
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, SOLUTION
INTRAVENOUS
Medical Information
V08CA02
gadoteric acid
Manufacturer Information
BAYER (SOUTH EAST ASIA) PTE LTD
Sanochemia Pharmazeutika GmbH
Active Ingredients
Documents
Package Inserts
Dotagraf PI.pdf
Approved: January 26, 2021