Published: 4 September 2025

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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:

  • 180mg
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:

  •  300mg
  •  400mg
Bipolar I disorder
Enhertu (trastuzumab deruxtecan)

Powder for infusion:

  • 100mg
Gastric cancer
Imfinzi (durvalumab)

Concentrate for infusion:

  • 120mg/2.4mL
  • 500mg/10mL
Endometrial cancer
Lynparza (olaparib)

Film coated tablet:

  • 100mg
  • 150mg
Endometrial cancer
Rinvoq (upadacitinib)

Modified release tablet:

  •  15mg
  •  30mg
  •  45mg
Giant cell arteritis
Ryeqo (relugolix + estradiol + norethisterone)

Film coated tablet:

  • 40mg + 1mg + 0.5mg
Endometriosis

* New packaging will be available towards the end of the year.

More information

See the Medsafe website for:

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