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Australian prescription medicine decision summaries

These decision summaries provide an overview of our evaluation process leading to the registration of a new prescription medicine.

For more information please visit the Australian prescription medicine decision summaries information page. 

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225 result(s) found, displaying 176 to 200
  • TGA decision: Inqovi 35/100 (decitabine and cedazuridine) is approved to treat adult patients with myelodysplastic syndromes and CMML.
  • TGA decision: MenQuadfi Quadrivalent meningococcal vaccine is approved for the prevention of invasive meningococcal disease.
  • TGA decision: Truvelog (insulin aspart) is approved to treat diabetes mellitus
  • TGA decision: Rymti, Etera (etanercept) is approved to treat rheumatoid arthritis and certain other inflammatory conditions.
  • TGA decision: Ongentys (opicapone) is approved as adjunctive therapy in adult patients with Parkinson's disease.
  • TGA decision: Epidyolex (cannabidiol) is approved as adjunctive therapy for seizures associated with Dravet and Lennox-Gastaut syndrome
  • TGA decision: Vitrakvi - larotrectinib sulfate is provisionally approved to treat patient with NTRK gene fusion metastatic solid tumours
  • TGA decision: Flucelvax Quad (quadrivalent influenza vaccine, surface antigen, inactivated) is approved for influenza vaccination
  • TGA decision: Tukysa (tucatinib), in combination with trastuzumab and capecitabine, is approved to treat HER2-positive breast cancer.
  • TGA decision: Luxturna (voretigene neparvovec) is approved to treat inherited retinal dystrophy caused by RPE65 mutations
  • TGA decision: Fluzone High-Dose Quadrivalent (influenza virus haemagglutinin) is approved for influenza immunisation.
  • Defitelio (defibrotide) is approved to treat severe hepatic veno-occlusive disease
  • Libtayo (cemiplimab) is provisionally approved to treat cutaneous squamous cell carcinoma in adults
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • TGA decision: Veklury (remdesivir) is provisionally approved to treat Coronavirus Disease 2019 (COVID-19) in adults and adolescents
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary

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