New Drug Indication Approvals
New drug indication approval - April 2023
Audiences
Healthcare professional
Industry member
Product type
Therapeutic Products
30 April 2023
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Product Name | ACTEMRA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML |
|---|---|
Active Ingredient | Tocilizumab |
Product Registrant | ROCHE SINGAPORE PTE LTD |
Date of Approval | 04/04/2023 |
Indications: Tocilizumab is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. | |
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Product Name | ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG |
|---|---|
Active Ingredient | Trastuzumab derutuxtecan |
Product Registrant | Astrazeneca Singapore Pte Ltd |
Date of Approval | 25/4/2023 |
Indications: HER2-Low ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy. *Evaluated as part of Project Orbis | |