New drug indication approval - November 2021

Product Name

OLUMIANT FILM COATED TABLET 2MG AND 4MG

Active Ingredient

Baricitinb

Product Registrant

DKSH Singapore Pte Ltd

Date of Approval

10/11/2021

Indications:

Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Product Name

PLAVIX TABLET 75 mg

Active Ingredient

CLOPIDOGREL HYDROGEN SULPHATE

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

15/11/2021

Indications:

Clopidogrel in combination with ASA is indicated in adult patients with moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) within 24 hours of either the TIA or IS event.

Product Name

BENLYSTA POWDER FOR SOLUTION FOR INFUSION 120MG, 400MG

Active Ingredient

Belimumab

Product Registrant

GlaxoSmithKline Pte Ltd

Date of Approval

15/11/2021

Indications:

Benlysta is indicated:

  • In combination with background immunosuppressive therapies for treatment of active lupus nephritis in adult patients.

Product Name

RINVOQ EXTENDED-RELEASE TABLET 15 MG

Active Ingredient

Upadacitinib Hemihydrate

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

19/11/2021

Indications:

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Ankylosing spondylitis

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Product Name

BOOSTRIX VACCINE

Active Ingredient

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ;

PERTACTIN; PERTUSSIS TOXOID and TETANUS TOXOID

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

23/11/2021

Indications:

Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see Posology).

The use of Boostrix should be in accordance with official recommendations.

Product Name

BOOSTRIX POLIO SUSPENSION FOR INJECTION

Active Ingredient

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ; INACTIVE POLIO VIRUS TYPE 1/ 2/ 3; PERTACTIN; PERTUSSIS TOXOID and TETANUS TOXOID

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

23/11/2021

Indications:

Boostrix Polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see Posology).

The use of Boostrix should be in accordance with official recommendations.

Product Name

LORVIQUA FILM COATED TABLET 25 MG

LORVIQUA FILM COATED TABLET 100 MG

Active Ingredient

Lorlatinib

Product Registrant

Pfizer Pte Ltd

Date of Approval

19/11/2021

Indications:

LORVIQUA is indicated for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

*Evaluated as part of Project Orbis

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals