We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
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.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Search
226 result(s) found, displaying 76 to 100
-
Prescription medicine decision summaryTGA decision: Letybo (letibotulinumtoxinA) is approved to treat the appearance of moderate to severe glabellar frown lines in adults.
-
Prescription medicine decision summaryOnpattro (patisiran) is approved to treat polyneuropathy.
-
Prescription medicine decision summaryKorsuva (difelikefalin acetate) is approved to treat chronic kidney disease
-
Prescription medicine decision summaryVazkepa (Icosapent ethyl) is approved to treat cardiovascular disease.
-
Prescription medicine decision summaryVabysmo (faricimab) is approved to treat macular degeneration.
-
Prescription medicine decision summaryComirnaty original/Omicron BA.1 COVID-19 Vaccine (Tozinameran and riltozinameran) is provisionally approved to treat COVID-19.
-
Prescription medicine decision summaryVerorab (inactivated rabies virus) is approved to treat rabies.
-
Prescription medicine decision summaryLivtencity (maribavir) is approved to treat cytomegalovirus (CMV).
-
Prescription medicine decision summaryCamzyos (mavacamten) is approved to treat cardiomyopathy.
-
-
Prescription medicine decision summaryTGA decision: Ciptunec Ardalicip (adalimumab) is approved to treat arthritis.
-
Prescription medicine decision summaryTGA decision: Pemazyre (pemigatinib) is approved to treat cancer
-
Prescription medicine decision summaryTGA decision: Byooviz (ranibizumab) is approved to treat visual impairment.
-
Prescription medicine decision summaryTGA decision: Filpegla (pegfilgrastim) is approved for the treatment of cancer patients following chemotherapy.
-
Prescription medicine decision summarySpikevax Bivalent Original/Omicron (elasomeran and imelasomeran) was approved for the prevention of COVID-19.
-
Prescription medicine decision summaryTGA decision: VOXZOGO (vosoritide) is approved to treat achondroplasia in patients 2 years of age and older whose epiphyses are not closed.
-
Prescription medicine decision summaryTGA decision: Exkivity (mobocertinib) is approved to treat lung cancer
-
Prescription medicine decision summaryTGA decision: Trastucip and Tuzucip (trastuzumab) are approved to treat breast cancer.
-
Prescription medicine decision summaryScemblix (asciminib) is approved to treat Philadelphia chromosome-positive chronic myeloid leukaemia.
-
Prescription medicine decision summaryPadcev (enfortumab vedotin) is approved to treat adult patients with locally advanced or metastatic urothelial cancer.
-
Prescription medicine decision summaryTGA decision: Xembify (normal immunoglobulin human) is approved to treat primary immunodeficiency diseases (PID).
-
Prescription medicine decision summaryTGA decision: VYXEOS (daunorubicin and cytarabine) is approved to treat therapy-related acute myeloid leukaemia and AML-MRC.
-
-
Prescription medicine decision summaryTGA decision: KIMMTRAK (tebentafusp) is approved to treat unresectable or metastatic uveal melanoma in HLA-A*02:01 positive patient.
-
Prescription medicine decision summaryTGA Decision: Lumakras (sotorasib) is approved to treat adult patients with non-small cell lung cancer (NSCLC).