| Product Name | COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV) |
| Active Ingredient | Famtozinameran(5 μg/dose),Tozinameran(5 μg/dose) |
| Application type | NDA-2: New combination |
| Product Registrant | BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD. |
| Date of Approval | 18/12/2023 |
| Registration No. | SIN16915P |
| Indications:COMIRNATY (Bivalent) (For Age 5 Years to < 12 Years) (Vials with Orange Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 to < 12 years of age. The use of this vaccine should be in accordance with official recommendations. | |
| Product Name | LIPOCOMB HARD CAPSULE 20MG/10MG, LIPOCOMB HARD CAPSULE 10MG/10MG |
| Active Ingredient | EZETIMIBE (10.00mg), ROSUVASTATIN ZINC EQV ROSUVASTATIN (20.00mg), EZETIMIBE (10.00mg), ROSUVASTATIN ZINC EQV ROSUVASTATIN (10.00mg) |
| Application type | NDA-2: New combination |
| Product Registrant | SERVIER (S) PTE LTD |
| Date of Approval | 21/12/2023 |
| Registration No. | SIN16919P, SIN16920P |
| Indications:Lipocomb is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. | |
| Product Name | NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 24 MG/1.2ML, NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 60 MG/1.2ML |
| Active Ingredient | Somatrogon(24mg/1.2ml), Somatrogon(60mg/1.2ml) |
| Application type | NDA-1: New biological entityNDA-3: Subsequent strength |
| Product Registrant | PFIZER PRIVATE LIMITED |
| Date of Approval | 14/12/2023 |
| Registration No. | SIN16911P, SIN16912P |
| Indications:NGENLA is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone (GH). | |
| Product Name | PLUVICTO SOLUTION FOR INJECTION/INFUSION 1000 MBQ/ML |
| Active Ingredient | Lutetium (177 Lu) vipivotide tetraxetan (1000 MBq/mL) |
| Application type | NDA-1: New chemical entity |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 18/12/2023 |
| Registration No. | SIN16917P |
| Indications:Pluvicto® is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibitor and taxane-based chemotherapy. | |
| Product Name | TRECONDI POWDER FOR SOLUTION FOR INFUSION 5 G PER VIAL, TRECONDI POWDER FOR SOLUTION FOR INFUSION 1 G PER VIAL |
| Active Ingredient | Treosulfan (5 g / vial), Treosulfan (1 g / vial) |
| Application type | NDA-1: New chemical entityNDA-3: Subsequent strength |
| Product Registrant | LINK HEALTHCARE SINGAPORE PTE LTD |
| Date of Approval | 26/12/2023 |
| Registration No. | SIN16922P, SIN16923P |
| Indications:Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) at increased risk of toxicity with standard conditioning therapies, and in paediatric patients older than one month with malignant diseases. | |
| Product Name | TRELEGY ELLIPTA INHALATION POWDER 200 MCG/62.5 MCG/25 MCG |
| Active Ingredient | FLUTICASONE FUROATE (MICRONISED)(200 MCG),UMECLIDINIUM BROMIDE (MICRONISED) EQV TO UMECLIDINIUM(62.5 MCG),VILANTEROL TRIFENATATE (MICRONISED) EQV TO VILANTEROL(25 MCG) |
| Application type | NDA-2: New presentation |
| Product Registrant | GLAXOSMITHKLINE PTE LTD |
| Date of Approval | 15/12/2023 |
| Registration No. | SIN16914P |
| Indications:ASTHMATrelegy Ellipta is indicated for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a long-acting beta2-agonist and an inhaled corticosteroid.COPDTrelegy Ellipta is indicated for maintenance treatment to prevent and relieve symptoms associated with moderate to severe chronic obstructive pulmonary disease (COPD) in patients who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (see Clinical Studies). | |
HSA: Health Sciences Authority
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approvals—december-2023
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