New drug indication approval - May 2021
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Product Name
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SOLIQUA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 100UNITS/ML + 50MCG/ML
SOLIQUA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 100UNITS/ML + 33MCG/ML
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Active Ingredient
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Insulin glargine, lixisenatide
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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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07/05/2021
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Indications:
Soliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. (For study results with respect to effect on glycaemic control, and the populations studied, see section 4.4 and 5.1).
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Product Name
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DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25 MG/VIAL
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Active Ingredient
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Triptorelin pamoate
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Product Registrant
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ZUELLIG PHARMA PTE LTD
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Date of Approval
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10/05/2021
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Indications:
As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
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Product Name
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OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML
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Active Ingredient
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Nivolumab
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Product Registrant
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BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
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Date of Approval
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12/05/2021
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Indications:
Oesophageal Squamous Cell Carcinoma (OSCC)
OPDIVO as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
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Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals