New drug indication approval - February 2023

Product Name

RINVOQ EXTENDED-RELEASE TABLET 15MG, 30MG

Active Ingredient

Upadacitinib Hemihydrate eqv Upadacitinib

Product Registrant

ABBVIE PTE LTD

Date of Approval

10 Feb 2023

Indications:

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Product Name

TECFIDERA GASTRO-RESISTANT HARD CAPSULES 120 MG AND 240MG

Active Ingredient

Dimethyl fumarate

Product Registrant

EISAI (SINGAPORE) PTE. LTD.

Date of Approval

17/02/2023

Indications:

Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Product Name

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 mg/2ml

Active Ingredient

Dupilumab

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

21/02/2023

Indications:

DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled severe chronic rhinosinusitis with nasal polyposis (CRSwNP).

Product Name

OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML

Active Ingredient

Nivolumab

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Date of Approval

22/02/2023

Indications:

Neoadjuvant treatment of NSCLC

OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumours ≥4 cm or node positive) NSCLC.

*Evaluated as part of Project Orbis