Prescription medicines: applications under evaluation (July 2021 update)

TGA

14 July 2021 - The TGA has updated its list of applications for new medicines/vaccines or new uses for existing medicines/vaccines that are currently under evaluation.

The list increased by 18 in June:

  • Cytosine arabinoside with daunorubicin (nanoparticle, liposomal) - new combination product
  • Agomelatine - new indication
  • Ravulizumab - new indication
  • Beclomethasone dipropionate with eformoterol) fumarate dihydrate and glycopyrronium bromide - new indication
  • Thiotepa - new indication
  • Diphtheria toxoid; haemophilus influenza type b polyribose ribitol phosphate; pertactin; pertussis filamentous haemagglutinin; pertussis fimbriae 2 + 3; pertussis toxoid; poliovirus; tetanus toxoid; hepatitis b surface antigen - new vaccine. The TGA has described this as a new medicine.
  • Somapacitan - new medicine
  • Varicella zoster virus vaccine (adjuvanted) - new indication
  • Lenvatinib mesylate - new indication
  • Pembrolizumab - new indication (renal cell carcinoma)
  • Pembrolizumab - new indication (squamous cell carcinoma)
  • Nitric oxide - new indication
  • Human papilloma virus vaccine (9 valent) - new indication
  • Influenza vaccine (quadrivalent, split virion) - new indication
  • Dupilimab - new indication (asthma)
  • BNT162b2 - new indication
  • Oestradiol hemihydrate with progesterone - new combination product
  • Glucagon - new formulation. The TGA has described this as a new medicine.

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Michael Wonder

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Michael Wonder

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Medicine , Australia , Dossier