Published: 7 March 2024

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Recent approvals: new active ingredients or new indications

Published 7 March 2024
Prescriber Update 45(1): 17–18
March 2024

New active ingredients

Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 13 October 2023 to 1 February 2024.

Table 1: Recent approvals of medicines with new active ingredients

Medicine New active ingredienta Dose form: strength(s) Therapeutic area
Verzenio Abemaciclib Film coated tablet: 50mg, 100mg, 150mg Breast cancer (hormone receptor [HR] positive, human epidermal growth factor receptor 2 [HER2] negative)
Ryeqo 40/1/0.5 Relugolix Film coated tablet: 40mg/1mg/0.5mg Uterine fibroids
Tukysa Tucatinib Film coated tablet: 50mg, 150mg Breast cancer (HER2 positive)
Comirnaty Omicron XBB 1.5 Raxtozinameran Suspension for injection: 0.1mg/mL COVID-19 prevention
Tremfya Guselkumab Solution for injection (pen and syringe): 100mg/mL Adults with plaque psoriasis or psoriatic psoriasis
Vumerity Diroximel fumarate Enteric coated capsule: 231mg Relapsing multiple sclerosis
  1. The medicine may also contain other active ingredients

New indications

Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 13 October 2023 to 1 February 2024.

Table 2: Approved medicines with new indications for additional therapeutic areas

Medicine (active ingredient) Dose form: strength(s) New therapeutic area
Jardiance (empagliflozin) Film coated tablet: 10mg, 25mg Chronic kidney disease

More information

See the Medsafe website for:

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