New drug indication approval - November 2021
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Product Name
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OLUMIANT FILM COATED TABLET 2MG AND 4MG
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Active Ingredient
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Baricitinb
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Product Registrant
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DKSH Singapore Pte Ltd
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Date of Approval
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10/11/2021
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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.
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Product Name
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PLAVIX TABLET 75 mg
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Active Ingredient
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CLOPIDOGREL HYDROGEN SULPHATE
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Product Registrant
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SANOFI-AVENTIS SINGAPORE PTE. LTD.
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Date of Approval
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15/11/2021
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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.
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Product Name
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BENLYSTA POWDER FOR SOLUTION FOR INFUSION 120MG, 400MG
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Active Ingredient
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Belimumab
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Product Registrant
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GlaxoSmithKline Pte Ltd
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Date of Approval
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15/11/2021
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Indications:
Benlysta is indicated:
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Product Name
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RINVOQ EXTENDED-RELEASE TABLET 15 MG
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Active Ingredient
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Upadacitinib Hemihydrate
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Product Registrant
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ABBVIE PTE. LTD.
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Date of Approval
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19/11/2021
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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.
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Product Name
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BOOSTRIX VACCINE
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Active Ingredient
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DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ;
PERTACTIN; PERTUSSIS TOXOID and TETANUS TOXOID
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Product Registrant
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GLAXOSMITHKLINE PTE LTD
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Date of Approval
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23/11/2021
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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.
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Product Name
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BOOSTRIX POLIO SUSPENSION FOR INJECTION
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Active Ingredient
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DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ; INACTIVE POLIO VIRUS TYPE 1/ 2/ 3; PERTACTIN; PERTUSSIS TOXOID and TETANUS TOXOID
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Product Registrant
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GLAXOSMITHKLINE PTE LTD
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Date of Approval
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23/11/2021
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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.
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Product Name
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LORVIQUA FILM COATED TABLET 25 MG
LORVIQUA FILM COATED TABLET 100 MG
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Active Ingredient
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Lorlatinib
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Product Registrant
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Pfizer Pte Ltd
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Date of Approval
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19/11/2021
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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
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Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals