New drug indication approval – December 2023

Product NameIDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/VIAL,
IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500IU/VIAL,
IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000IU/VIAL,
IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2000IU/VIAL
Active IngredientAlbutrepenonacog alfa(250IU/vial),
Albutrepenonacog alfa(500IU/vial),
Albutrepenonacog alfa(1000IU/Vial),
Albutrepenonacog alfa(2000IU/vial)
Product RegistrantCSL BEHRING PTE. LTD.
Date of Approval26/12/2023
Indications:Prophylaxis and treatment of bleeding in patients with haemophilia B (congenital factor IX deficiency) including control and prevention of bleeding in surgical settings.
Product NameTRELEGY ELLIPTA INHALATION POWDER 100 MCG/62.5 MCG/25 MCG
Active IngredientFLUTICASONE FUROATE (MICRONISED)(100 mcg),UMECLIDINIUM BROMIDE (MICRONISED) 74.2 MCG EQV TO UMECLIDINIUM(62.5 MCG),VILANTEROL TRIFENATATE (MICRONISED) 40 MCG EQV TO VILANTEROL(25 MCG)
Product RegistrantGLAXOSMITHKLINE PTE LTD
Date of Approval15/12/2023
Indications:Trelegy 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.
Product NameMENQUADFI SOLUTION FOR INJECTION
Active IngredientMeningococcal Polysaccharide, Serogroup A (Monovalent Conjugate) (10 mcg/ 0.5 mL), Meningococcal Polysaccharide, Serogroup C (Monovalent Conjugate) (10 mcg/ 0.5 mL), Meningococcal Polysaccharide, Serogroup W-135 (Monovalent Conjugate) (10 mcg / 0.5mL), Meningococcal Polysaccharide, Serogroup Y (Monovalent Conjugate) (10 mcg/ 0.5 mL), Tetanus Toxoid, Filtered Concentrate (Carrier Protein)(55 mcg/ 0.5 mL)
Product RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval21/12/2023
Indications:MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The use of this vaccine should be in accordance with available official recommendations.
Product NameJARDIANCE FILM-COATED TABLETS 10 MG
Active IngredientEmpagliflozin 10 mg
Product RegistrantBOEHRINGER INGELHEIM SINGAPORE
Date of Approval26/12/2023
Indications:JARDIANCE is indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalisation in adults with chronic kidney disease at risk of progression.

HSA: Health Sciences Authority

Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-indication-approvals/new-drug-indication-approval—december-2023


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