New drug indication approval - August 2023

Product Name

SAIZEN SOLUTION FOR INJECTION 5.83MG/ML (6MG IN 1.03ML), 8.00MG/ML (12MG IN 1.50ML)

Active Ingredient

Somatropin

Product Registrant

MERCK PTE. LTD.

Date of Approval

15/08/2023

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 Name

COMIRNATY, CONCENTRATE FOR DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE

COMIRNATY, CONCENTRATE FOR DISPERSION FOR INJECTION, 30 MICROGRAMS/DOSE

Active Ingredient

Tozinameran

Product Registrant

BionTech Pharmaceuticals Asia Pte. Ltd

Date of Approval

23/08/2023

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 Name

IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML

Active Ingredient

Durvalumab

Product Registrant

Astrazeneca Singapore Pte Ltd

Date of Approval

25/08/2023

Indications:

IMFINZI in combination with tremelimumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC).

Product Name

BOOSTAGEN SUSPENSION FOR INJECTION

Active Ingredient

Diptheria Toxoid (DT), Filamentous haemagglutinin (FHA), Recombinant Pertussis Toxin (rPT), Tetanus Toxoid (TT)

Product Registrant

Novem Healthcare Pte Ltd

Date of Approval

31/08/2023

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 Name

OLUMIANT FILM-COATED TABLET 4MG

OLUMIANT FILM-COATED TABLET 2MG

Active Ingredient

Baricitinib

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

31/08/2023

Indications:

Alopecia areata

Baricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1)