Published: 3 June 2021

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Recent approvals: new active ingredients or new indications

Published: 3 June 2021
Prescriber Update 42(2): 29
June 2021

For the period 16 January 2021 to 15 April 2021.

Recent approvals of medicines with new active ingredients

Trade name (active ingredient) Dose form and strength(s) Therapeutic area
Comirnaty (COVID-19 mRNA vaccine) Concentrate for injection
0.5 mg/mL
Immunisation to prevent COVID-19
Mayzent (siponimod) Film coated tablet
0.25 mg
2 mg
Multiple sclerosis
Vyvanse (lisdexamfetamine) Capsule
30 mg
50 mg
70 mg
Attention deficit hyperactivity disorder (ADHD)

Approved medicines with new indications

Trade Name (active ingredient) Dose form and strength(s) New therapeutic area(s)
Forxiga (dapagliflozin) Film coated tablet
10 mg
Chronic kidney disease
Opdivo (nivolumab) Concentrate for infusion
40 mg/4 mL
100 mg/10 mL
Non-small cell lung cancer
Sirturo (bedaquiline) Tablet
100 mg
Tuberculosis in paediatric patients (aged 12 years to less than 18 years)
Sprycel (dasatinib) Film coated tablet
20 mg
50 mg
70 mg
100 mg
Paediatric patients with Philadelphia chromosome positive:
· chronic myeloid leukaemia
· acute lymphoblastic leukaemia
Toujeo (neutral insulin) Solution for injection
300 IU/mL
Diabetes mellitus in patients aged 6 years and older


See the Medsafe website for:

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