New drug indication approval - Jan 2021

Product Name

PRIORIX-TETRA

Active Ingredient

Live attenuated rubella virus (Wistar RA 27/3 strain)(≥ 10³ CCID50/dose)

Live attenuated measles virus (Schwarz strain)(≥ 10³ CCID50/dose)

Live attenuated mumps virus (RIT4385 strain)(≥ 10⁴·⁴ CCID50/dose)

Live attenuated varicella virus (OKA strain)(≥ 10³·³ PFU/dose)

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

19/01/2021

Indications:

Priorix-Tetra is indicated for active immunisation of subjects from the age of 12 months against measles, mumps, rubella and varicella. (see also Warnings and Precautions, Pharmacodynamics).

The use of Priorix-Tetra should be based on official recommendations.

Product Name

TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 MG/ML

Active Ingredient

Guselkumab

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

25/01/2021

Indications:

TREMFYA by subcutaneous (SC) administration is indicated for the treatment of moderate to severe palmoplantar pustulosis (PPP) in adult patients who do not adequately respond to conventional therapy.

Product Name

OFEV SOFT CAPSULES 100MG, 150MG

Active Ingredient

Nintedanib

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE PTE LTD

Date of Approval

26/01/2021

Indications:

OFEV is indicated for the treatment of chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype [see section Clinical Trials]

Product Name

DURATOCIN RTS SOLUTION FOR INJECTION 100MCG/ML

Active Ingredient

Carbetocin

Product Registrant

FERRING PHARMACEUTICALS PRIVATE LIMITED

Date of Approval

13/01/2021

Indications:

DURATOCIN® RTS is indicated for the prevention of postpartum haemorrhage due to uterine atony.