| Product Name | COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 300MG/2MLCOSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150MG/MLCOSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 75MG/0.5MLCOSENTYX SOLUTION FOR INJECTION IN PREFILLED SENSOREADY PEN 150MG/MLCOSENTYX SOLUTION FOR INJECTION IN PRE-FILLED UNOREADY PEN 300MG/2ML |
| Active Ingredient | Secukinumab |
| Product Registrant | Novartis (Singapore) Pte Ltd. |
| Date of Approval | 06/09/2023 |
| Indications: Cosentyx is indicated for the treatment of moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic therapy (See clinical trials section). | |
| Product Name | BRUKINSA CAPSULE 80 MG |
| Active Ingredient | Zanubrutinib |
| Product Registrant | BEIGENE SINGAPORE PTE LTD |
| Date of Approval | 08/09/2023 |
| Indications: BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [see Clinical Studies (14.4)]. | |
| Product Name | STAMICIS KIT FOR RADIOPHARMACEUTICAL PREPARATION 1MG |
| Active Ingredient | Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate |
| Product Registrant | QT INSTRUMENTS (S) PTE LTD |
| Date of Approval | 15/09/2023 |
| Indications:· – Assessment of global ventricular function. First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion. – Localisation of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands. | |
| Product Name | TUKYSA FILM-COATED TABLETS 50 MG AND 150 MG |
| Active Ingredient | Tucatinib |
| Product Registrant | MSD PHARMA (SINGAPORE) PTE. LTD. |
| Date of Approval | 18/09/2023 |
| Indications: TUKYSA is indicated in combination with trastuzumab for the treatment of patients with RAS wild-type, HER2- positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. | |
| Product Name | ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL |
| Active Ingredient | Trastuzumab deruztecan |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 20/09/2023 |
| Indications: ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy. | |
| Product Name | OZEMPIC 1MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML |
| Active Ingredient | Semaglutide |
| Product Registrant | NOVO NORDISK PHARMA (SINGAPORE) PTE LTD |
| Date of Approval | 22/09/2023 |
| Indications: To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease (see Pharmacodynamic Properties). | |
| Product Name | IMBRUVICA FILM-COATED TABLETS 140MG, 280MG AND 420MG |
| Active Ingredient | Ibrutinib |
| Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD |
| Date of Approval | 27/09/2023 |
| Indications: Chronic lymphocytic leukemia / Small lymphocytic lymphoma (CLL/SLL) IMBRUVICA® as a single agent, or in combination with rituximab or obinutuzumab or venetoclax, is indicated for the treatment of adult patients with previously untreated CLL/SLL. | |
| Product Name | REVOLADE TABLET 25MG AND 50MG |
| Active Ingredient | Eltrombopag olamine |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 28/09/2023 |
| Indications: Revolade is indicated for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade is indicated for immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis in paediatric patients aged 6 years and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). | |
HSA: Health Sciences Authority
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-indication-approvals/new-drug-indication-approval—september-2023
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