Australian prescription medicine decision summaries

​TGA decision: Alhemo is approved where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have haemophilia B.

We have approved Retevmo (selpercatinib) to treat adult patients with Non-Small Cell Lung Cancer (NSCLC).

We have provisionally approved Andexxa (andexanet alfa) for patients treated with a direct factor Xa inhibitor, when reversal of anticoagulation is needed.

We have approved Minjuvi (tafasitamab) to treat diffuse large B-cell lymphoma (DLBCL).

The medicine Imjudo (tremelimumab), in combination with durvalumab, is approved to treat adult patients with unresectable hepatocellular carcinoma (uHCC).

The medicine Tecvayli (teclistamab) has been approved by the TGA to treat multiple myeloma.

​TGA decision: Intrarosa (prasterone) is approved to treat vulvar and vaginal atrophy in postmenopausal women.

​TGA decision: Esperoct (turoctocog alfa pegol) is approved to treat haemophilia A.

TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with advanced or metastatic rearranged during transfection- fusion positive thyroid cancer.

TGA decision: Tibsovo (ivosidenib) is approved to treat cancer.

TGA decision: Teriparatide Lupin and LAPL and GH (teriparatide acetate) are approved for the treatment of osteoporosis.

TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with locally advanced or metastatic rearranged during transfection fusion-positive non-small cell lung cancer.

TGA decision: Jivi (damoctocog alfa pegol) is approved to treat adults and adolescents (12 years of age and older) with haemophilia A

TGA decision: Sunlenca (lenacapavir sodium) is approved to treat multidrug resistant HIV-1 infection.

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

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

Sotyktu (deucravacitinib) is approved to treat plaque psoriasis.