New drug indication approval - December 2023

Product Name

IDELVION 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 Ingredient

Albutrepenonacog alfa(250IU/vial),
Albutrepenonacog alfa(500IU/vial),
Albutrepenonacog alfa(1000IU/Vial),
Albutrepenonacog alfa(2000IU/vial)

Product Registrant

CSL BEHRING PTE. LTD.

Date of Approval

26/12/2023

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 Name

TRELEGY ELLIPTA INHALATION POWDER 100 MCG/62.5 MCG/25 MCG

Active Ingredient

FLUTICASONE 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 Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

15/12/2023

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 Name

MENQUADFI SOLUTION FOR INJECTION

Active Ingredient

Meningococcal 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 Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

21/12/2023

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 Name

JARDIANCE FILM-COATED TABLETS 10 MG

Active Ingredient

Empagliflozin 10 mg

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE

Date of Approval

26/12/2023

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.