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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 1 to 25
  • Voranigo (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.
  • Zilbrysq (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.
  • Fabhalta (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).
  • Hepcludex (bulevirtide acetate) was approved to treat chronic hepatitis delta virus infection in adults with compensated liver disease.
  • Pluvicto (Lutetium (177Lu) vipivotide tetraxetan) has been approved for the treatment of adult patients with prostate cancer who have received prior treatments.
  • Litfulo (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.
  • Awiqli (insulin icodec) has been approved for the treatment of type 1 and type 2 diabetes in adults.
  • Elrexfio (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.
  • Mirena 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.
  • Oxlumo (lumasiran) has been approved for the treatment of primary hyperoxaluria type 1.
  • Amvuttra (vutrisiran) was approved for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
  • Cibinqo (abrocitinib) has been approved for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
  • Tevimbra (tislelizumab) has been approved for the treatment of patients with various types of oesophageal squamous cell carcinoma and non-small cell lung cancer.
  • Velsipity (etrasimod) treats moderately to severely active ulcerative colitis (inflammation and ulcers in the digestive tract).
  • Ebglyss (lebrikizumab) is for the treatment of moderate to severe atopic dermatitis (atopic eczema) in patients older than the age of twelve.
  • Truqap (capivasertib), in combination with fulvestrant, is approved for the treatment of adult patients with locally advanced or metastatic breast cancer.
  • Nelarabine-Reach (nelarabine) is an anti-cancer drug approved for the treatment of relapsing/refractory T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma.
  • Hemgenix (etranacogene dezaparvovec) has been approved for the treatment of adults with haemophilia B (congenital factor IX deficiency).
  • Lokelma (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.
  • Abrysvo (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.
  • Verdye (indocyanine green) was approved for diagnostics relating to cardiac, circulatory, liver and eye functions.
  • Winlevi (clascoterone) cream was approved for the topical treatment of acne vulgaris in patients 12 years of age and older.
  • Spy 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.
  • Onakta (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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