Australian Public Assessment Reports (AusPAR)

Intrarosa (prasterone) has been approved for the treatment of vulvar and vaginal atrophy.

Flucelvax Quad (Influenza virus haemagglutinin), a vaccine for the prevention of influenza caused by Influenza Virus Types A and B , has been approved.

Gavreto (pralsetinib) has been approved for the treatment of adult patients with advanced or metastatic RET-fusion positive thyroid cancer.

Esperoct (turoctocog alfa pegol) has been approved to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A.

Gavreto (pralsetinib) has been approved for the treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer.

Teriparatide Lupin/ Teriparatide LAPL/ Teriparatide GH (teriparatide) has been approved for the treatment of osteoporosis.

Spikevax XBB.1.5 (andusomeran) has been approved for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

Tavneos (avacopan), in combination with a rituximab- or cyclophosphamide-based regimen, has been approved for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis

Tibsovo (Ivosidenib) has been approved for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.

Nuceiva (prabotulinum toxin A) is indicated for the temporary improvement in appearance of glabellar lines.

WELIREG (belzutifan) is indicated for treatment of patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery.

Vazkepa (icosapent ethyl) has been approved for the reduction of the incidence of cardiovascular events in adults.

Comirnaty (tozinameran), a vaccine, has been approved for the prevention of coronavirus disease 2019 (COVID-19) in individuals 12 years of age and older.

Withdrawn submission related to AusPAR for MVC COVID-19 Vaccine, for the prevention of novel coronavirus disease (COVID-19).

Vaxneuvance, a vaccine, has been approved for the prevention of pneumococcal disease caused by Streptococcus pneumoniae.

Spikevax (Elasomeran/davesomeran), a vaccine, has transitioned from provisional to full registration. Spikevax is for the prevention of coronavirus disease 2019 caused by SARS-CoV-2.

AusPAR for Gardasil 9 (HPV 9-valent vaccine, recombinant) for prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by HPV in males.

Keytruda (pembrolizumab) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

AusPAR for Rybrevant (amivantamab) for treatment of patients with NSCLC that has an EGFR exon 20 insertion mutation.

AusPAR for Sotyktu (deucravacitinib) for treatment of adult patients with moderate-to-severe plaque psoriasis.

AusPAR for Onpattro (patisiran) for treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

AusPAR for full registration for COMIRNATY (tozinameran) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

AusPAR for Camzyos (mavacamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy.

AusPAR for Pemazyre (pemigatinib) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy.

AusPAR for Trecondi for the treatment of adults with acute myeloid leukaemia or myelodysplastic syndrome, and paediatric population with malignant and non-malignant haematological diseases.