New drug indication approval - June 2023
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Product Name
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DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300MG/2ML
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Active Ingredient
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Dupilumab
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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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04/06/2023
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Indications:
1.4 Prurigo Nodularis
DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe prurigo nodularis (PN) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
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Product Name
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IDACIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML
IDACIO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.8ML
IDACIO SOLUTION FOR INJECTION FOR PAEDIATRIC USE 40MG/0.8ML VIAL
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Active Ingredient
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Acdalimumab
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Product Registrant
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FRESENIUS KABI (SINGAPORE) PTE LTD
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Date of Approval
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13/06/2023
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Indications:
Pediatric Ulcerative Colitis
IDACIO is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
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Product Name
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AMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 20MG/0.4ML AND 40MG/0.8ML
AMGEVITA SOLUTION FOR INJECTION IN PREFILLED AUTOINJECTOR 40MG/0.8ML
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Active Ingredient
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Adalimumab
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Product Registrant
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AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
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Date of Approval
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05/06/2023
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Indications:
Pediatric Ulcerative Colitis
AMGEVITA is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
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Product Name
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ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 20 MG/0.4 ML
ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED PEN 40 MG/0.8 ML
ABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 40 MG/0.8 ML
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Active Ingredient
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Adalimumab
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Product Registrant
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PFIZER PRIVATE LIMITED
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Date of Approval
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16/06/2023
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Indications:
Paediatric ulcerative colitis
ABRILADA is indicated for inducing and maintaining clinical remission in paediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
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Product Name
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SCEMBLIX FILM-COATED TABLET 20 MG
SCEMBLIX FILM-COATED TABLET 40 MG
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Active Ingredient
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Asciminib hydrochloride
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Product Registrant
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NOVARTIS (SINGAPORE) PTE LTD
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Date of Approval
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22/06/2023
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Indications:
Scemblix® is indicated for the treatment of adult patients with:
· Ph+ CML in CP harboring the T315I mutation.
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Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals