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
TABLET, FILM COATED
ORAL
Medical Information
L04AA45
xl 04 aa 45
Manufacturer Information
EISAI (SINGAPORE) PTE. LTD.
Rottendorf Pharma GmbH
Bushu Pharmaceuticals Ltd. Kawagoe Factory (Primary packager and secondary packager)
Active Ingredients
Documents
Package Inserts
JYSELECA PI.pdf
Approved: March 27, 2024