| Product Name | GOOFICE FILM-COATED TABLET 5MG |
| Active Ingredient | Elobixibat |
| Application type | NDA-1: New chemical entity |
| Product Registrant | EISAI (SINGAPORE) PTE. LTD. |
| Date of Approval | 02/10/2023 |
| Registration No. | SIN16878P |
| Indications: GOOFICE® is indicated for the treatment of chronic idiopathic constipation in adults. | |
| Product Name | PAXLOVID FILM-COATED TABLETS |
| Active Ingredient | Nirmatrelvir, Ritonavir |
| Application type | NDA-1: New chemical entity(Transition from PSAR to marketing authorisation) |
| Product Registrant | PFIZER PRIVATE LIMITED |
| Date of Approval | 02/10/2023 |
| Registration No. | SIN16877P |
| Indications: PAXLOVID is indicated for the treatment of mild-to-moderate Coronavirus Disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. | |
| Product Name | SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5(50 MICROGRAMS/50 MICROGRAMS)/ML DISPERSION FOR INJECTION |
| Active Ingredient | Elasomeran, Davesomeran |
| Application type | NDA-1: New biological entity |
| Product Registrant | MODERNA BIOTECH SINGAPORE PTE. LTD. |
| Date of Approval | 11/10/2023 |
| Registration No. | SIN16881P |
| Indications: Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1).The use of this vaccine should be in accordance with official recommendations. | |
| Product Name | SPEVIGO CONCENTRATE FOR SOLUTION FOR INFUSION 450 MG/7.5 ML |
| Active Ingredient | Spesolimab |
| Application type | NDA-1: New biological entity |
| Product Registrant | BOEHRINGER INGELHEIM SINGAPORE PTE. LTD. |
| Date of Approval | 12/10/2023 |
| Registration No. | SIN16883P |
| Indications: SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults. | |
| Product Name | NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5µG/DOSE (RECOMBINANT, ADJUVANTED) |
| Active Ingredient | SARS-CoV-2 recombinant Spike Protein (rS) |
| Application type | NDA-1: New biological entity |
| Product Registrant | PHARMENG TECHNOLOGY PTE LTD |
| Date of Approval | 17/10/2023 |
| Registration No. | SIN16886P |
| Indications: Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. | |
| Product Name | PERIOLIMEL N4E EMULSION FOR INFUSION |
| Active Ingredients | (Compartment 1) Alanine 3.66g/L(Compartment 1) Arginine 2.48g/L(Compartment 1) Aspartic Acid 0.73g/L(Compartment 1) Glutamic Acid 1.26g/L(Compartment 1) Glycine 1.76g/L(Compartment 1) Histidine 1.51g/L(Compartment 1) Isoleucine 1.26g/L(Compartment 1) Leucine 1.76g/L(Compartment 1) Lysine Acetate eqv Lysine 1.99g/L(Compartment 1) Magnesium Chloride Hexahydrate 0.45g/L(Compartment 1) Methionine 1.26g/L(Compartment 1) Phenylalanine 1.76g/L(Compartment 1) Potassium Chloride 1.19g/L(Compartment 1) Proline 1.51g/L(Compartment 1) Serine 1.00g/L(Compartment 1) Sodium Acetate Trihydrate 1.16g/L(Compartment 1) Sodium Glycerophosphate, Hydrated 1.91g/L(Compartment 1) Threonine 1.26g/L(Compartment 1) Tryptophan 0.42g/L(Compartment 1) Tyrosine 0.06g/L(Compartment 1) Valine 1.62g/L(Compartment 2) Calcium Chloride Dihydrate 0.30g/L(Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 75.0g/L(Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 30g/L |
| Application type | NDA-2: New combination |
| Product Registrant | BAXTER HEALTHCARE (ASIA) PTE LTD |
| Date of Approval | 20/10/2023 |
| Registration No. | SIN16888P |
| Indications: PeriOLIMEL N4E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated. | |
| Product Name | OLIMEL N7E EMULSION FOR INFUSION |
| Active Ingredients | (Compartment 1) Alanine 6.41g/L(Compartment 1) Arginine 4.34g/L(Compartment 1) Aspartic Acid 1.28g/L(Compartment 1) Glutamic Acid 2.21g/L(Compartment 1) Glycine 3.07g/L(Compartment 1) Histidine 2.64g/L(Compartment 1) Isoleucine 2.21g/L(Compartment 1) Leucine 3.07g/L(Compartment 1) Lysine Acetate eqv Lysine 3.48g/L(Compartment 1) Magnesium Chloride Hexahydrate 0.81g/L(Compartment 1) Methionine 2.21g/L(Compartment 1) Phenylalanine 3.07g/L(Compartment 1) Potassium Chloride 2.24g/L(Compartment 1) Proline 2.64g/L(Compartment 1) Serine 1.75g/L(Compartment 1) Sodium Acetate Trihydrate 1.50g/L(Compartment 1) Sodium Glycerophosphate, Hydrated 3.67g/L(Compartment 1) Threonine 2.21g/L(Compartment 1) Tryptophan 0.74g/L(Compartment 1) Tyrosine 0.11g/L(Compartment 1) Valine 2.83g/L(Compartment 2) Calcium Chloride Dihydrate 0.52g/L(Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 140g/L(Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 40g/L |
| Application type | NDA-3: Line extension |
| Product Registrant | BAXTER HEALTHCARE (ASIA) PTE LTD |
| Date of Approval | 20/10/2023 |
| Registration No. | SIN16889P |
| Indications: OLIMEL N7E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated. | |
| Product Name | OLIMEL N9E EMULSION FOR INFUSION |
| Active Ingredients | (Compartment 1) Alanine 8.24g/L(Compartment 1) Arginine 5.58g/L(Compartment 1) Aspartic Acid 1.65g/L(Compartment 1) Glutamic Acid 2.84g/L(Compartment 1) Glycine 3.95g/L(Compartment 1) Histidine 3.40g/L(Compartment 1) Isoleucine 2.84g/L(Compartment 1) Leucine 3.95g/L(Compartment 1) Lysine Acetate eqv Lysine 4.48g/L(Compartment 1) Magnesium Chloride Hexahydrate 0.81g/L(Compartment 1) Methionine 2.84g/L(Compartment 1) Phenylalanine 3.95g/L(Compartment 1) Potassium Chloride 2.24g/L(Compartment 1) Proline 3.40g/L(Compartment 1) Serine 2.25g/L(Compartment 1) Sodium Acetate Trihydrate 1.50g/L(Compartment 1) Sodium Glycerophosphate, Hydrated 3.67g/L(Compartment 1) Threonine 2.84g/L(Compartment 1) Tryptophan 0.95g/L(Compartment 1) Tyrosine 0.15g/L(Compartment 1) Valine 3.64g/L(Compartment 2) Calcium Chloride Dihydrate 0.52g/L(Compartment 2) Glucose Monohydrate eqv Glucose Anhydrous 110.0g/L(Compartment 3) Refined Olive Oil + Soya-bean Oil (80:20) 40g/L |
| Application type | NDA-3: Line extension |
| Product Registrant | BAXTER HEALTHCARE (ASIA) PTE LTD |
| Date of Approval | 20/10/2023 |
| Registration No. | SIN16890P |
| Indications: OLIMEL N9E is indicated for parenteral nutrition for adults and children greater than 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated. | |
| Product Name | SKIIP NICOTINE MINI LOZENGE 2MG (MINT) |
| Active Ingredient | Nicotine Polacrilex |
| Application type | NDA-2: New salt /dosage form |
| Product Registrant | RUBICON RESEARCH PRIVATE LIMITED |
| Date of Approval | 30/10/2023 |
| Registration No. | SIN16895P |
| Indications: Nicotine Mini Lozenge belongs to a group of medicines which are used to help you stop smoking. | |
HSA: Health Sciences Authority
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approvals—october-2023
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