Published: 7 December 2023
Publications
Recent approvals: new active ingredients or new indications
Published: 7 December 2023
Prescriber Update 44(4): 82
December 2023
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 14 July 2023 to 12 October 23.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Galafold | Migalastat | Capsule, 123mg | Fabry disease (alpha-galactosidase A deficiency) for patients aged 16 years and older |
| Vabysmo | Faricimab | Solution for injection, 120mg/mL | Neovascular (wet) age-related macular degeneration (nAMD), Diabetic macular oedema (DMO) |
| Zonisamide Te Arai | Zonisamide | Capsule: 25mg, 50mg, 100mg | Epilepsy |
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 14 July 2023 to 12 October 2023.
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 (100mg/4mL) | Cutaneous squamous cell carcinoma |
More information
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