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New Drug Indication Approval - Sep 2019

 

Product Name

CABOMETYX FILM COATED TABLET 20 MG, 40 MG AND 60 MG

Active Ingredient

Cabozantinib

Product Registrant

IPSEN PHARMA PTE LTD

Date of Approval

06/09/2019

Indications:

Renal Cell Carcinoma (RCC)
CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk (see section 5.1).
Hepatocellular Carcinoma (HCC)
CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. 

 

Product Name

XARELTO FILM COATED TABLETS 2.5MG

Active Ingredient

Rivaroxaban

Product Registrant

 BAYER (SOUTH EAST ASIA) PTE LTD

Date of Approval

26/09/2019
Indications: XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in adult patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD) at high risk of ischemic events.

 

Product Name

BOOSTRIX VACCINE

Active Ingredient

Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis antigens 

Product Registrant

 GLAXOSMITHKLINE PTE LTD

Date of Approval

27/09/2019

Indications: Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards.

 


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New Drug Indication Approvals