Australian prescription medicine decision summaries

TGA decision: Radicava (edaravone) is approved to treat adults with a diagnosis of amyotrophic lateral sclerosis.

approved to prevent coronavirus disease 2019 (COVID-19)

Nuceiva (prabotulinumtoxinA) is approved to treat glabellar lines.

Doptelet (avatrombopag maleate) is approved to treat thrombocytopenia in adult patients.

Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine (tozinameran and famtozinameran) is approved to prevent coronavirus disease 2019.

Mounjaro (tirzepatide) is approved to treat diabetes.

Welireg (belzutifan) is approved to treat adult patients with von Hippel-Lindau (VHL) disease

Evusheld (tixagevimab and cilgavimab) is approved to treat COVID-19

TGA decision: Rybrevant (amivantamab) is approved to treat lung cancer

TGA decision: Prevenar 20 (Pneumococcal purified capsular polysaccharides) is approved to prevent pneumococcal disease.

Sotyktu (deucravacitinib) is approved to treat plaque psoriasis.

TGA decision: Letybo (letibotulinumtoxinA) is approved to treat the appearance of moderate to severe glabellar frown lines in adults.

Onpattro (patisiran) is approved to treat polyneuropathy.

Korsuva (difelikefalin acetate) is approved to treat chronic kidney disease

Vazkepa (Icosapent ethyl) is approved to treat cardiovascular disease.

Vabysmo (faricimab) is approved to treat macular degeneration.

Comirnaty original/Omicron BA.1 COVID-19 Vaccine (Tozinameran and riltozinameran) is provisionally approved to treat COVID-19.

Verorab (inactivated rabies virus) is approved to treat rabies.

Livtencity (maribavir) is approved to treat cytomegalovirus (CMV).

Camzyos (mavacamten) is approved to treat cardiomyopathy.

Trecondi (treosulfan) is approved to treat cancer

TGA decision: Xembify (normal immunoglobulin human) is approved to treat primary immunodeficiency diseases (PID).

Padcev (enfortumab vedotin) is approved to treat adult patients with locally advanced or metastatic urothelial cancer.

Scemblix (asciminib) is approved to treat Philadelphia chromosome-positive chronic myeloid leukaemia.

TGA decision: Trastucip and Tuzucip (trastuzumab) are approved to treat breast cancer.