Published: 4 December 2025

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Recent approvals: new active ingredients or new indications

Published: 4 December 2025
Prescriber Update 46(4): 69
December 2025

New active ingredients

Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 25 July 2025 to 23 October 2025.

Table 1: Recent approvals of medicines with new active ingredients

Medicine New active ingredient(s) Dose form: strength(s) Therapeutic area
Alyftrek* Vanzacaftor, Deutivacaftor Film coated tablet:
  • 4 mg + 20 mg* + 50 mg 
  • 10 mg + 50 mg* + 125 mg
 Cystic fibrosis
Berinert IV Berinert SC Human C1-esterase inhibitor Powder for injection with diluent:
  • 500 IU (IV)
  • 1500 IU (IV)
  • 2000 IU (SC)
  • 3000 IU (SC)
 Hereditary angioedema
Camzyos Mavacamten Capsule:
  • 2.5 mg
  • 5 mg
  • 10 mg
  • 15 mg
 Cardiomyopathy
Elahere Mirvetuximab Concentrate for injection:
  • 100 mg/20mL
 Epithelial ovarian, fallopian tube, or primary peritoneal cancer
Saphnelo Anifrolumab Concentrate for infusion:
  • 150 mg/mL
 Systemic lupus erythematosus 

* Also contains tezacaftor

New indications

Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 25 July 2025 to 23 October 2025.

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

Medicine (active ingredient) Dose form: strength(s) New therapeutic area
Nicorette Quick Mist (nicotine) Oral spray
  • 1 mg/spray
 Nicotine vaping dependence 

More information


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