Published: 5 December 2024
Publications
Recent approvals: new active ingredients or new indications
Prescriber Update 45(4): 92
December 2024
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 19 July 2024 to 17 October 2024.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Jynneosa | Vaccinia vaccine | Suspension for injection: 0.5mL | Prevention of mpox disease in adults |
| Topaminea | Silver diamine fluoride | Topical solution: 38% | Dental caries, dentinal hypersensitivity |
a. Provisional consent
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 19 July 2024 to 17 October 2024.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) |
Dose form: strength(s) | New therapeutic area |
|---|---|---|
| Fasenra (benralizumab) | Solution for injection in prefilled syringe or pen: 30mg/mL | Eosinophilic granulomatosis with polyangiitis (EGPA) – adult patients |
| Vabysmo (faricimab) | Solution for intravitreal injection: 120mg/mL | Macular oedema secondary to retinal vein occlusion (RVO) |
| Nubeqa (darolutamide) | Film coated tablet: 300 mg | Metastatic hormone sensitive prostate cancer (mHSPC) |
| Enhertu (trastuzumab deruxtecan) | Powder for infusion: 100mg | HER2-low breast cancer |
| Keytruda (pembrolizumab) | Concentrate for infusion: 25mg/mL | Gastric or gastroesophageal junction adenocarcinoma |
More information
See the Medsafe website for:
