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HSA Approval

ORSERDU FILM-COATED TABLET 345 MG

Approval Number

SIN17096P

Drug Name

ORSERDU FILM-COATED TABLET 345 MG

Product Name

ORSERDU FILM-COATED TABLET 345 MG

Approval Date

September 25, 2024

Registrant

A. MENARINI SINGAPORE PTE. LTD.

Regulatory Information

Registrant

A. MENARINI 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

L02BA04

Manufacturer Information

Pharmaceutical Manufacturer

A. MENARINI SINGAPORE PTE. LTD.

Manufacturers

CATALENT GREENVILLE, INC.

Active Ingredients

Ingredient Name

ELACESTRANT DIHYDROCHLORIDE eqv ELACESTRANT

Strength

345 MG

Drug MonographElacestrant

Documents

Package Inserts

Orserdu film coated Tablet PI.pdf

Approved: September 25, 2024

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