New drug indication approval – August 2023

Product NameSAIZEN SOLUTION FOR INJECTION 5.83MG/ML (6MG IN 1.03ML), 8.00MG/ML (12MG IN 1.50ML)
Active IngredientSomatropin
Product RegistrantMERCK PTE. LTD.
Date of Approval15/08/2023
Indications:

Saizen® (Only for 6 mg and 12 mg) is indicated in the treatment of:· Growth failure in prepubertal children due to chronic renal failure (CRF).· Growth disturbance due to idiopathic short stature (ISS).
Product NameCOMIRNATY, CONCENTRATE FOR DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSECOMIRNATY, CONCENTRATE FOR DISPERSION FOR INJECTION, 30 MICROGRAMS/DOSE
Active IngredientTozinameran
Product RegistrantBionTech Pharmaceuticals Asia Pte. Ltd
Date of Approval23/08/2023
Indications:

COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 years of age and older.The use of this vaccine should be in accordance with official recommendations.
Product NameIMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
Active IngredientDurvalumab
Product RegistrantAstrazeneca Singapore Pte Ltd
Date of Approval25/08/2023
Indications:

IMFINZI in combination with tremelimumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC).
Product NameBOOSTAGEN SUSPENSION FOR INJECTION
Active IngredientDiptheria Toxoid (DT), Filamentous haemagglutinin (FHA), Recombinant Pertussis Toxin (rPT), Tetanus Toxoid (TT)
Product RegistrantNovem Healthcare Pte Ltd
Date of Approval31/08/2023
Indications:

Boostagen®is indicated for:- active booster immunization against tetanus, diphtheria and pertussis in individuals from the age of 3 years onwards.- maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated.Boostagen® is not indicated for primary immunization.
Product NameOLUMIANT FILM-COATED TABLET 4MGOLUMIANT FILM-COATED TABLET 2MG
Active IngredientBaricitinib
Product RegistrantDKSH SINGAPORE PTE. LTD.
Date of Approval31/08/2023
Indications:

Baricitinib is indicated for the treatment of severe alopecia areata in adult patients.

HSA: Health Sciences Authority

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


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