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Product Name
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REXULTI FILM-COATED TABLETS 4MG, 3MG, 2MG, 1MG, 0.5MG AND 0.25MG
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Active Ingredient
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Brexpiprazole
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Application type
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NDA-1: New chemical entity
NDA-3: New strengths
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Product Registrant
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LUNDBECK SINGAPORE PTE. LTD.
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Date of Approval
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05/08/2019
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Registration No.
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SIN15763P, SIN15764P, SIN15765P, SIN15766P, SIN15767, SIN15768P
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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). The long-term efficacy of brexpiprazole as adjunctive treatment in MDD has not been established.
· Treatment of schizophrenia (see section 5.1).
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Product Name
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BERIATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION 250IU/VIAL, 500IU/VIAL
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Active Ingredient
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Human coagulation factor VIII
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Application type
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NDA-2: Others (Factor VIII product)
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Product Registrant
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CSL Behring Pte Ltd
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Date of Approval
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07/08/2019
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Registration No.
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SIN15771P, SIN15772P
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Indications:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
This product may be used in the management of acquired factor VIII deficiency.
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