Published: 5 June 2025
Publications
Recent approvals: new active ingredients or new indications
Published: 5 June 2025
Prescriber Update 46(2):
26
June 2025
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 1 February 2025 to 24 April 2025.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Fenofibrate Viatris | Fenofibrate | Film coated tablet: 48mg, 145mg | Hypercholesterolaemia, dyslipidaemia, diabetic retinopathy |
| Omjjara | Momelotinib | Film coated tablet: 100mg, 150mg, 200mg | Myelofibrosis |
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 1 February 2025 to 24 April 2025.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form: strength(s) | New therapeutic area |
|---|---|---|
| Keytruda (pembrolizumab) | Concentrate for infusion: 25mg/mL | Malignant pleural mesothelioma |
| Kisqali (ribociclib) | Film coated tablet: 200mg | Early breast cancer |
| Saizen (somatropin) | Solution for injection: 5.83mg/mL, 8mg/mL | Growth disturbance in short children born small for gestational age |
More information
See the Medsafe website for:
