New drug indication approval - August 2024
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | SOLIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL |
| Active Ingredient (Strength) | Eculizumab (300 mg / vial) |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 21/08/2024 |
Indications:
SOLIRIS is indicated in adults for the treatment of patients with:
• Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).
• Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive (see section 5.1). |
| Product Name | ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250 ΜG/VIAL |
| Active Ingredient (Strength) | ROMIPLOSTIM 375 μg/vial (250 μg/vial (deliverable amount)) |
| Product Registrant | KYOWA KIRIN ASIA PACIFIC PTE. LTD. |
| Date of Approval | 15/08/2024 |
Indications:
Romiplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). |
| Product Name | VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML |
| Active Ingredient (Strength) | Faricimab (6.00mg/0.05ml) |
| Product Registrant | ROCHE SINGAPORE PTE. LTD. |
| Date of Approval | 06/08/2024 |
Indications:
Vabysmo is indicated for the treatment of adult patients with:
· macular edema secondary to retinal vein occlusion (RVO) (see section 3.1.2 Clinical Efficacy Studies). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals