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Australian prescription medicine decision summaries

Search our decision summaries for the registration of new prescription medicines.

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

We have redesigned our prescription medicine decision summaries (AusPMDSs) to make it easier to understand how prescription medicines are registered in Australia. 

The redesigned AusPMDSs will offer clear, accessible information about recent medicine registration decisions.

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253 result(s) found, displaying 1 to 25

  • ALTUVIIIO (efanesoctocog alfa)

    Prescription medicine decision summary
    ALTUVIIIO (efanesoctocog alfa) is approved for adults, adolescents and children with haemophilia A.

  • Sodium Oxybate-Reach (sodium oxybate)

    Prescription medicine decision summary
    Sodium Oxybate-Reach has been approved for the treatment of narcolepsy in adults, adolescents and children from the age of 7 years.

  • Wainua (eplontersen)

    Prescription medicine decision summary
    Wainua (eplontersen) is approved for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adults with stage 1 or 2 polyneuropathy.

  • Cifoban (sodium citrate dihydrate)

    Prescription medicine decision summary
    Cifoban (sodium citrate dihydrate) is approved for use in adults and children for regional citrate anticoagulation (RCA) in continuous venovenous haemodialysis (CVVHD), continuous venovenous haemodiafiltration (CVVHDF), sustained low efficiency (daily) dialysis (SLEDD) and therapeutic plasma exchange (TPE) via membrane plasma separation.

  • Tabrecta (capmatinib)

    Prescription medicine decision summary
    Tabrecta has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. Tabrecta contains the active ingredient capmatinib.

  • Zirdawny (donidalorsen)

    Prescription medicine decision summary
    Zirdawny has been approved for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

  • Slenyto (melatonin)

    Prescription medicine decision summary
    Slenyto has been approved for the treatment of insomnia in children and adolescents with neurogenetic disorders and/or attention-deficit hyperactivity disorder (ADHD).

  • Hibruka (orelabrutinib)

    Prescription medicine decision summary
    Hibruka (orelabrutinib) has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

  • Cenrifki (tolebrutinib)

    Prescription medicine decision summary
    Cenrifki (tolebrutinib) has been approved for the treatment of Secondary Progressive Multiple Sclerosis (SPMS) in adults.

  • Tzield (teplizumab)

    Prescription medicine decision summary
    Tzield (teplizumab) is approved to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus.

  • Rhapsido (remibrutinib)

    Prescription medicine decision summary
    Rhapsido has been approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Rhapsido contains the active ingredient remibrutinib.

  • Qalsody (tofersen)

    Prescription medicine decision summary
    Qalsody has been provisionally approved for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. ALS is a type of motor neurone disease (MND).

  • Filsuvez (Birch bark dry extract - 84-95% triterpenes)

    Prescription medicine decision summary
    Filsuvez (Birch bark dry extract - 84-95% triterpenes) has been approved for the treatment of partial-thickness wounds of the skin associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

  • Niktimvo (axatilimab)

    Prescription medicine decision summary
    Niktimvo is approved for the treatment of chronic graft-versus host disease (cGVHD). Niktimvo contains the active ingredient axatilimab.

  • Orserdu (elacestrant)

    Prescription medicine decision summary
    Orserdu is approved for the treatment of advanced breast cancer in postmenopausal women, and men. Orserdu contains the active ingredient elacestrant.

  • Redemplo (plozasiran)

    Prescription medicine decision summary
    Redemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS).

  • Zynlonta (loncastuximab tesirine)

    Prescription medicine decision summary
    Zynlonta is provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Zynlonta contains the active ingredient loncastuximab tesirine.

  • Yesintek (ustekinumab)

    Prescription medicine decision summary
    Yesintek is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults, and plaque psoriasis in children aged 6 years and older.

  • Enflonsia (clesrovimab)

    Prescription medicine decision summary
    Enflonsia has been approved to help prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.

  • Jaypirca (pirtobrutinib)

    Prescription medicine decision summary
    Jaypirca (pirtobrutinib) is approved for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who have been previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

  • Elahere (mirvetuximab soravtansine)

    Prescription medicine decision summary
    Elahere (mirvetuximab soravtansine) has been approved to treat adults with folate receptor-alpha (FRα) positive cancer of the ovary, fallopian tubes, or peritoneum who have stopped responding to platinum based chemotherapy and who have had one to 3 chemotherapy treatments before.

  • Livdelzi (seladelpar)

    Prescription medicine decision summary
    Livdelzi (seladelpar) is approved to treat primary biliary cholangitis (PBC) in adults in combination with ursodeoxycholic acid (UDCA) when UDCA alone isn't effective, or on its own if UDCA can’t be tolerated.

  • Adzynma (apadamtase alfa/cinaxadamtase alfa)

    Prescription medicine decision summary
    Adzynma (apadamtase alfa/ cinaxadamtase alfa) has been approved for the treatment of ADAMTS13 deficiency in adults and children with congenital thrombotic thrombocytopenic purpura (cTTP).