New drug indication approval - Sep 2020

Product Name

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150MG/ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SENSOREADY PEN 150MG/ML

COSENTYX POWDER FOR SOLUTION FOR INJECTION 150MG/VIAL

Active Ingredient

Secukinumab

Product Registrant

Novartis

Date of Approval

3/09/2020

Indications:

Cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-AxSpa) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).

Product Name

TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML

Active Ingredient

Atezolizumab

Product Registrant

Roche

Date of Approval

3/09/2020

Indications:

Tecentriq, in combination with Avastin, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Product Name

ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION 400 MG

Active Ingredient

Aripiprazole

Product Registrant

LUNDBECK SINGAPORE PTE. LTD.

Date of Approval

03/09/2020

Indications:

- For the acute and maintenance treatment of schizophrenia in adults

- For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy

Product Name

GARDASIL 9 SUSPENSION FOR INJECTION

Active Ingredient

Human papilloma virus (HPV) type 6, 11, 16, 18, 31, 33, 45, 52 and 58

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

07/09/2020

Indications: 

GARDASIL 9 is a vaccine indicated in girls and women from 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, and anal cancer; premalignant genital lesions (cervical, vulvar and vaginal); premalignant anal lesions; HPV infections; cervical adenocarcinoma in sity (AIS); and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58. 

GARDASIL 9 is indicated in boys and men from 9 through 45 years of age for the prevention of premalignant lesions and HPV infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Product Name

OFEV SOFT CAPSULES 100MG AND 150MG

Active Ingredient

Nintedanib

Product Registrant

Boehringer Ingelheim Singapore Pte Ltd

Date of Approval

21/09/2020

Indications: 

Ofev is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease. 

Product Name

Amgevita Solution for Injection in prefilled syringe 40mg/0.8ml

Amgevita Solution for Injection in prefilled syringe 20mg/0.4ml

Amgevita Solution for injection in prefilled autoinjector 40mg/0.8ml

Active Ingredient

Adalimumab

Product Registrant

Amgen Biotechnology Singapore Pte. Ltd.

Date of Approval

21/09/2020

Indications: 

Pediatric Uveitis

AMGEVITA is indicated for the treatment of chronic non-infectious anterior uveitis in pediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.