Published: 2 December 2021


Recent approvals: new active ingredients or new indications

Published: 2 December 2021
Prescriber Update 42(4): 53–54
December 2021

For the period 16 July 2021 to 15 October 2021.

Recent approvals of medicines with new active ingredients

Trade name (active ingredient) Dose form and strength(s) Therapeutic area
Xofluza (baloxavir marboxil) Film-coated tablet
20 mg
40 mg
Calquence (acalabrutinib) Capsule
100 mg
Mantle cell lymphoma
Chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL)
Piqray (alpelisib) Film-coated tablet
200 mg
250 mg (200 mg + 50 mg)
300 mg (150 mg +150 mg)
Hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation
Trumenba (Neisseria meningitidis group B factor H binding protein subfamily A + subfamily B) Suspension for injection
120 mcg/0.5 mL
Meningococcal B disease
Trulicity (dulaglutide) Solution for injection
3 mg/mL
Type 2 diabetes mellitus

Approved medicines with new indications

Trade Name (active ingredient) Dose form and strength(s) New therapeutic area(s)
Rinvoq (upadacitinib hemihydrate) Modified release tablet
15 mg
Atopic dermatitis
Vicks Vaporub (eucalyptus oil; menthol) Topical ointment
1.33%; 2.82%
Keytruda (pembrolizumab) Concentrate for infusion
25 mg/mL
Oesophageal cancer

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