| Product Name | NAGLAZYME CONCENTRATE FOR SOLUTION FOR INFUSION |
| Active Ingredient | Galsulfase |
| Application type | NDA-1: New biological entity |
| Product Registrant | PHARM-D SINGAPORE PRIVATE LIMITED |
| Date of Approval | 11/08/2023 |
| Registration No. | SIN16831P |
| Indications: NAGLAZYME is indicated for long-term enzyme replacement therapy in patients with Mucopolysaccharidosis VI (MPS VI, N-acetylgalactosamine 4-sulfatase deficiency, Maroteaux-Lamy syndrome). | |
| Product Name | ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION IN PFS 400 MG |
| Active Ingredient | Aripiprazole |
| Application type | NDA-2: New dosage form |
| Product Registrant | LUNDBECK SINGAPORE PTE LTD |
| Date of Approval | 14/08/2023 |
| Registration No. | SIN16832P |
| Indications: – For the acute and maintenance treatment of schizophrenia in adults – For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy | |
| Product Name | ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION IN PFS 400 MG |
| Active Ingredient | Aripiprazole |
| Application type | NDA-2: New dosage form |
| Product Registrant | LUNDBECK SINGAPORE PTE LTD |
| Date of Approval | 14/08/2023 |
| Registration No. | SIN16832P |
| Indications: – For the acute and maintenance treatment of schizophrenia in adults – For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy | |
| Product Name | SPIKEVAX 0.2 mg/mL DISPERSION FOR INJECTION |
| Active Ingredient | Elasomeran |
| Application type | NDA-1: New biological entity(Transition from PSAR to marketing authorisation) |
| Product Registrant | MODERNA BIOTECH SINGAPORE PTE. LTD. |
| Date of Approval | 17/08/2023 |
| Registration No. | SIN16834P |
| Indications: Spikevax is indicated for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 6 years of age and older.The use of this vaccine should be in accordance with official recommendations. | |
| Product Name | SPIKEVAX 0.1 mg/mL DISPERSION FOR INJECTION |
| Active Ingredient | Elasomeran |
| Application type | NDA-2: New strength(Transition from PSAR to marketing authorisation) |
| Product Registrant | MODERNA BIOTECH SINGAPORE PTE. LTD. |
| Date of Approval | 17/08/2023 |
| Registration No. | SIN16835P |
| Indications: Spikevax is indicated for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 6 months of age and older.The use of this vaccine should be in accordance with official recommendations. | |
| Product Name | GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBq |
| Active Ingredient | Germanium (68Ge) chloride; Gallium (68Ga) chloride |
| Application type | NDA-1: New chemical entity |
| Product Registrant | LABGISTICS ASIA PTE LTD |
| Date of Approval | 23/08/2023 |
| Registration No. | SIN16844P |
| Indications: This pharmaceutical product is not intended for direct use in patients.The eluate from the radionuclide generator (gallium (68Ga) chloride solution) is indicated for in vitro labelling of specific carrier molecules developed and approved for radiolabelling with such solution to be used for positron emission tomography (PET) imaging. | |
| Product Name | IMJUDO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML |
| Active Ingredient | Tremelimumab |
| Application type | NDA-1: New biological entity |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 25/08/2023 |
| Registration No. | SIN16845P |
| Indications: IMJUDO in combination with durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy. | |
| Product Name | SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML |
| Active Ingredient | Sodium Selenite |
| Application type | NDA-2: New presentation |
| Product Registrant | AGUETTANT ASIA PACIFIC PTE. LTD. |
| Date of Approval | 27/08/2023 |
| Registration No. | SIN16847P |
| Indications: Selenium supplementation during parenteral nutrition. Treatment of proven selenium deficiency that cannot be compensated by nutrition alone. | |
| Product Name | OPDUALAG CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/80MG |
| Active Ingredient | Nivolumab/relatlimab |
| Application type | NDA-1: New biological entity |
| Product Registrant | BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD. |
| Date of Approval | 31/08/2023 |
| Registration No. | SIN16852P |
| Indications: Opdualag is indicated for the first-line treatment of unresectable or metastatic melanoma in adults with tumour cell PD-L1 expression < 1%. | |
HSA: Health Sciences Authority
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approvals—august-2023
Only Authentic Products and Genuine Medical Supplies, at POM Marketplace!
Login or Register now to access our comprehensive range of medical supplies.
Disclaimer: The information provided on this page is intended solely for healthcare professionals for informational purposes only. While we strive for accuracy, POMConnect assumes no liability for errors or omissions. The content here should not be considered a substitute for professional medical advice. POMConnect does not endorse specific treatments or external websites linked from this page. Please note that the information is accurate at the time of publication and does not account for any modifications or updates made to the original research article after its initial publish date. POM Marketplace is accessible to qualified healthcare professionals only. Any unauthorized access or use by individuals who do not meet this criteria is prohibited.
