Published: 4 September 2025
Publications
Recent approvals: new active ingredients or new indications
Published: 4 September 2025
Prescriber Update 46(3): 48
September 2025
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 25 April 2025 to 24 July 2025.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Trodelvy | Sacituzumab |
Powder for infusion:
|
Breast cancer |
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 25 April 2025 to 24 July 2025.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form: strength(s) | New therapeutic area |
|---|---|---|
| Abilify Maintena* (aripiprazole) |
Injection with diluent:
|
Bipolar I disorder |
| Enhertu (trastuzumab deruxtecan) |
Powder for infusion:
|
Gastric cancer |
| Imfinzi (durvalumab) |
Concentrate for infusion:
|
Endometrial cancer |
| Lynparza (olaparib) |
Film coated tablet:
|
Endometrial cancer |
| Rinvoq (upadacitinib) |
Modified release tablet:
|
Giant cell arteritis |
| Ryeqo (relugolix + estradiol + norethisterone) |
Film coated tablet:
|
Endometriosis |
* New packaging will be available towards the end of the year.
More information
See the Medsafe website for:
