Published: 5 March 2026
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Recent approvals: New active ingredients or new indications
Published: 5 March 2026
Prescriber Update 47(1): 15–16
March 2026
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 24 October 2025 to 22 January 2026.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Comirnaty LP.8.1 | SARS-CoV-2 spike protein (mRNA) LP.8.1 | Concentrate or suspension for injection Multidose vial: 3mcg/0.3mL dose, 10mcg/0.3mL dose, 30mcg/0.3mL dose Single dose vial: 10mcg/0.3mL dose Prefilled syringe: 30mcg/0.3mL dose |
COVID-19 disease |
| Itovebi | Inavolisib | Film coated tablet: 3mg, 9mg | Breast cancer |
| Mounjaro | Tirzepatide | Solution for injection Pre-filled pen: 2.5mg/0.5mL, 5mg/0.5mL, 7.5 mg/0.5mL, 10mg/0.5mL, 12.5mg/0.5mL, 15mg/0.5mL Vial: 2.5mg/0.5mL, 5mg/0.5mL, 7.5 mg/0.5mL, 10mg/0.5mL, 12.5mg/0.5mL, 15mg/0.5mL KwikPen: 4.17mg/mL, 8.33mg/mL, 12.5mg/mL, 16.67mg/mL, 20.83mg/mL, 25mg/mL |
Type 2 diabetes mellitus; Chronic weight management |
| Welireg | Belzutifan | Film coated tablet: 40mg | von Hippel-Lindau disease-associated tumours; Advanced renal cell carcinoma |
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 24 October 2025 to 22 January 2026.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form: strength(s) | New therapeutic area |
|---|---|---|
| Mekinist (trametinib) | Film coated tablet: 0.5mg, 2mg Powder for oral solution: 0.05mg/mL |
Paediatric gliomaa |
| Tafinlar (dabrafenib) | Capsule: 50mg, 75mg Dispersible tablet: 10mg |
Paediatric gliomab |
- Trametinib in combination with dabrafenib.
- Dabrafenib in combination with trametinib.
More information
See the Medsafe website for:
