Published: 3 September 2026
Publications
Recent approvals: New active ingredients or new indications
Published: 3 September 2026
Prescriber Update 47(3): 50
September 2026
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 24 April 2026 to 23 July 2026.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: Strength(s) | Therapeutic area |
|---|---|---|---|
| Intuniv | Guanfacine | Modified release tablet: 1mg, 2mg, 3mg, 4mg | Attention deficit hyperactivity disorder (ADHD) |
| Beyfortus | Nirsevimab | Solution for injection: 50mg/0.5mL, 100mg/mL | Prevention of Respiratory Syncytial Virus (RSV) |
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 24 April 2026 to 23 July 2026.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form: Strength(s) | New therapeutic area |
|---|---|---|
| Tremfya (guselkumab) |
Concentrate for infusion: 200mg/20mL
Solution for injection (pre-filled pen): 100mg/mL, 200mg/2mL Solution for injection (pre-filled syringe): 100mg/mL, 200mg/2mL |
Ulcerative colitis; Crohn’s disease |
More information
See the Medsafe website for:
