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HSA Approval

JYSELECA FILM-COATED TABLET 100MG

Approval Number

SIN16980P

Drug Name

JYSELECA FILM-COATED TABLET 100MG

Product Name

JYSELECA FILM-COATED TABLET 100MG

Approval Date

March 27, 2024

Registrant

EISAI (SINGAPORE) PTE. LTD.

Regulatory Information

Registrant

EISAI (SINGAPORE) PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

Medical Information

ATC Code

L04AA45

ATC Item Name

xl 04 aa 45

Manufacturer Information

Pharmaceutical Manufacturer

EISAI (SINGAPORE) PTE. LTD.

Manufacturers

Rottendorf Pharma GmbH

Bushu Pharmaceuticals Ltd. Kawagoe Factory (Primary packager and secondary packager)

Active Ingredients

Ingredient Name

Filgotinib maleate eqv filgotinib

Strength

100 mg

Drug MonographFilgotinib

Documents

Package Inserts

JYSELECA PI.pdf

Approved: March 27, 2024

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