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 76 to 100
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Prescription medicine decision summaryOnpattro (patisiran) is approved to treat polyneuropathy.
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Prescription medicine decision summaryKorsuva (difelikefalin acetate) is approved to treat chronic kidney disease
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Prescription medicine decision summaryVazkepa (Icosapent ethyl) is approved to treat cardiovascular disease.
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Prescription medicine decision summaryVabysmo (faricimab) is approved to treat macular degeneration.
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Prescription medicine decision summaryComirnaty original/Omicron BA.1 COVID-19 Vaccine (Tozinameran and riltozinameran) is provisionally approved to treat COVID-19.
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Prescription medicine decision summaryVerorab (inactivated rabies virus) is approved to treat rabies.
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Prescription medicine decision summaryLivtencity (maribavir) is approved to treat cytomegalovirus (CMV).
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Prescription medicine decision summaryCamzyos (mavacamten) is approved to treat cardiomyopathy.
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Prescription medicine decision summaryTGA decision: Ciptunec Ardalicip (adalimumab) is approved to treat arthritis.
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Prescription medicine decision summaryTGA decision: Pemazyre (pemigatinib) is approved to treat cancer
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Prescription medicine decision summaryTGA decision: Byooviz (ranibizumab) is approved to treat visual impairment.
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Prescription medicine decision summaryTGA decision: Filpegla (pegfilgrastim) is approved for the treatment of cancer patients following chemotherapy.
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Prescription medicine decision summarySpikevax Bivalent Original/Omicron (elasomeran and imelasomeran) was approved for the prevention of COVID-19.
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Prescription medicine decision summaryTGA decision: VOXZOGO (vosoritide) is approved to treat achondroplasia in patients 2 years of age and older whose epiphyses are not closed.
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Prescription medicine decision summaryTGA decision: Exkivity (mobocertinib) is approved to treat lung cancer
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Prescription medicine decision summaryTGA decision: Trastucip and Tuzucip (trastuzumab) are approved to treat breast cancer.
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Prescription medicine decision summaryScemblix (asciminib) is approved to treat Philadelphia chromosome-positive chronic myeloid leukaemia.
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Prescription medicine decision summaryPadcev (enfortumab vedotin) is approved to treat adult patients with locally advanced or metastatic urothelial cancer.
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Prescription medicine decision summaryTGA decision: Xembify (normal immunoglobulin human) is approved to treat primary immunodeficiency diseases (PID).
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Prescription medicine decision summaryTGA decision: VYXEOS (daunorubicin and cytarabine) is approved to treat therapy-related acute myeloid leukaemia and AML-MRC.
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Prescription medicine decision summaryTGA decision: KIMMTRAK (tebentafusp) is approved to treat unresectable or metastatic uveal melanoma in HLA-A*02:01 positive patient.
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Prescription medicine decision summaryTGA Decision: Lumakras (sotorasib) is approved to treat adult patients with non-small cell lung cancer (NSCLC).
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Prescription medicine decision summaryTGA Decision: Saphnelo (anifrolumab) is approved to treat adult patients with active systemic lupus erythematosus (SLE).