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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245 result(s) found, displaying 1 to 25
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Prescription medicine decision summaryCenrifki (tolebrutinib) has been approved for the treatment of Secondary Progressive Multiple Sclerosis (SPMS) in adults.
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Prescription medicine decision summaryTzield (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.
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Prescription medicine decision summaryRhapsido 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.
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Prescription medicine decision summaryQalsody 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).
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Prescription medicine decision summaryFilsuvez (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.
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Prescription medicine decision summaryNiktimvo is approved for the treatment of chronic graft-versus host disease (cGVHD). Niktimvo contains the active ingredient axatilimab.
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Prescription medicine decision summaryOrserdu is approved for the treatment of advanced breast cancer in postmenopausal women, and men. Orserdu contains the active ingredient elacestrant.
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Prescription medicine decision summaryRedemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS).
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Prescription medicine decision summaryZynlonta 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.
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Prescription medicine decision summaryYesintek 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.
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Prescription medicine decision summaryQdenga (live, attenuated - dengue virus serotypes 1, 2, 3, and 4) is a vaccine approved to provide protection against dengue disease for adults, adolescents, and children aged 4 years and over.
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Prescription medicine decision summaryEnflonsia 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.
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Prescription medicine decision summaryJaypirca (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.
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Prescription medicine decision summaryElahere (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.
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Prescription medicine decision summaryLivdelzi (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.
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Prescription medicine decision summarymNEXSPIKE XBB.1.5 (SARS-CoV-2 spike protein (mRNA) XBB.1.5) is a vaccine approved to prevent COVID-19 caused by SARS-CoV-2, in individuals aged 12 years and older.
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Prescription medicine decision summaryAdzynma (apadamtase alfa/ cinaxadamtase alfa) has been approved for the treatment of ADAMTS13 deficiency in adults and children with congenital thrombotic thrombocytopenic purpura (cTTP).
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Prescription medicine decision summaryAlyftrek (vanzacaftor, tezacaftor, deutivacaftor) has been approved to treat people with cystic fibrosis who are 6 years and older. It has 3 active ingredients that target the genetic cause of cystic fibrosis.
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Prescription medicine decision summaryEkterly (sebetralstat) has been approved for hereditary angioedema (HAE) attacks caused by C1 inhibitor deficiency or dysfunction, in patients aged 12 years and older.
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Prescription medicine decision summarySteqeyma (ustekinumab) has been approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, crohn's disease, and ulcerative colitis
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Prescription medicine decision summaryVoranigo (vorasidenib) is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma in adults and paediatric patients 12 years and older who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.
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Prescription medicine decision summaryZilbrysq (zilucoplan) has been approved as an add-on to standard therapy for the treatment of generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.
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Prescription medicine decision summaryFabhalta (iptacopan) has been approved for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (a condition where red blood cells are destroyed by the immune system).
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Prescription medicine decision summaryHepcludex (bulevirtide acetate) was approved to treat chronic hepatitis delta virus infection in adults with compensated liver disease.
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Prescription medicine decision summaryPluvicto (Lutetium (177Lu) vipivotide tetraxetan) has been approved for the treatment of adult patients with prostate cancer who have received prior treatments.