Summary of Benefit-risk Assessment Reports
The reports contain a summary of the quality, safety and efficacy of approved new chemicals and biologics, and HSA's benefit-risk assessment for the approvals.
8 items
27 August 2026
Aphexda Lyophilized Powder for Solution for Injection 62mg/ml
The summary report for this therapeutic product is available for download
New drug application
21 July 2026
Iqirvo Film-Coated Tablet 80mg
The summary report for this therapeutic product is available for download
New drug application
8 June 2026
Lytgobi Film-coated Tablets 4mg
The summary report for this therapeutic product is available for download
New drug application
5 June 2026
Byfavo Powder For Solution For Injection 20mg
The summary report for this therapeutic product is available for download
New drug application
30 April 2026
Nemluvio Powder and Solvent for solution for injection in Pre-filled Pen/Syringe 30mg
The summary report for this therapeutic product is available for download
New drug application
9 April 2026
Ebglyss Solution for Injection in Pre-filled Pen 250mg/2ml
The summary report for this therapeutic product is available for download
New drug application
9 April 2026
Veoza Film coated Tablet
The summary report for this therapeutic product is available for download
New drug application
1 January 2025
Archive
View summary reports of therapeutic products approved from 2020-2025
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