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HSA Product

REXULTI FILM-COATED TABLETS 0.25MG

Product approved by Health Sciences Authority (SG)

Basic Information

REXULTI FILM-COATED TABLETS 0.25MG

TABLET, FILM COATED

Regulatory Information

SIN15768P

August 5, 2019

Prescription Only

Therapeutic

ORAL

August 10, 2023

June 3, 2025

XN05AX16

Company Information

Active Ingredients

BREXPIPRAZOLE

Strength: 0.25mg

Detailed Information

Contraindications

**4.3 CONTRAINDICATIONS** Hypersensitivity to the active substance or to any of the excipients.

Indication Information

**4.1 THERAPEUTIC INDICATIONS** Brexpiprazole is indicated in adult patients for: - Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was demonstrated in 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The long-term efficacy of brexpiprazole as adjunctive treatment in MDD has not been established. - Treatment of schizophrenia (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) in adults and pediatric patients aged 13 years and older.

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