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 26 to 50
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Prescription medicine decision summaryLitfulo (ritlecitinib) has been approved for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. Alopecia areata is an autoimmune disease that causes hair loss.
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Prescription medicine decision summaryRelfydess (relabotulinumtoxinA, purified Botulinum toxin type A) has been approved for the temporary improvement in the appearance of glabellar lines ("frown lines") and lateral canthal lines ("crows feet").
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Prescription medicine decision summaryAwiqli (insulin icodec) has been approved for the treatment of type 1 and type 2 diabetes in adults.
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Prescription medicine decision summaryElrexfio (elranatamab) has been provisionally approved for the treatment of adult patients with relapsed or refractory multiple myeloma and who have not benefited from 3 prior therapies.
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Prescription medicine decision summaryMirena is a device which is inserted into the uterus that provides long-term, reversible contraception. The duration for use as a contraceptive has been extended from 5 years to 8 years.
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Prescription medicine decision summaryOxlumo (lumasiran) has been approved for the treatment of primary hyperoxaluria type 1.
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Prescription medicine decision summaryAmvuttra (vutrisiran) was approved for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
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Prescription medicine decision summaryCibinqo (abrocitinib) has been approved for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
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Prescription medicine decision summaryTevimbra (tislelizumab) has been approved for the treatment of patients with various types of oesophageal squamous cell carcinoma and non-small cell lung cancer.
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Prescription medicine decision summaryVelsipity (etrasimod) treats moderately to severely active ulcerative colitis (inflammation and ulcers in the digestive tract).
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Prescription medicine decision summaryEbglyss (lebrikizumab) is for the treatment of moderate to severe atopic dermatitis (atopic eczema) in patients older than the age of twelve.
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Prescription medicine decision summaryTruqap (capivasertib), in combination with fulvestrant, is approved for the treatment of adult patients with locally advanced or metastatic breast cancer.
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Prescription medicine decision summaryNelarabine-Reach (nelarabine) is an anti-cancer drug approved for the treatment of relapsing/refractory T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma.
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Prescription medicine decision summaryHemgenix (etranacogene dezaparvovec) has been approved for the treatment of adults with haemophilia B (congenital factor IX deficiency).
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Prescription medicine decision summaryLokelma (sodium zirconium cyclosilicate hydrate) was approved for the treatment of hyperkalaemia in adult patients. Lokelma binds to potassium in the gut and is used to treat high levels of potassium in the blood.
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Prescription medicine decision summaryAbrysvo (recombinant respiratory syncytial virus pre-fusion F protein bivalent vaccine) was approved for the prevention of lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV) in certain patient groups.
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Prescription medicine decision summaryVerdye (indocyanine green) was approved for diagnostics relating to cardiac, circulatory, liver and eye functions.
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Prescription medicine decision summaryWinlevi (clascoterone) cream was approved for the topical treatment of acne vulgaris in patients 12 years of age and older.
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Prescription medicine decision summarySpy Agent Green (indocyanine green) is an imaging agent that has been approved for the visualisation of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts, lymph nodes and lymphatic vessels.
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Prescription medicine decision summaryOnakta (tirbanibulin) is indicated for the topical field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis of the face or scalp in adults.
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Prescription medicine decision summaryVeoza (fezolinetant) has been approved for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.
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Prescription medicine decision summaryErwinase (crisantaspase) has been approved as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who have developed hypersensitivity to pegylated asparaginase obtained from E. coli.
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Prescription medicine decision summaryOnbevzi (bevacizumab) is a biosimilar of Avastin. Onbevzi has been approved to treat a range of cancers either as a monotherapy or in combination with other anti-cancer medicines.
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Prescription medicine decision summaryWezlana (ustekinumab) has been approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
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Prescription medicine decision summaryArexvy (recombinant respiratory syncytial virus pre-fusion F protein) is approved for individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus