Published: 7 September 2023


Recent approvals: new active ingredients or new indications

Published: 7 September 2023
Prescriber Update 44(3): 60
September 2023

New active ingredients

Table 1 shows recent approval of medicines with new active ingredients, gazetted during the period 7 April 2023 to 13 July 2023.

Table 1: Recent approvals of medicines with new active ingredients

Medicine New active ingredient Dose form: strength(s) Therapeutic area
Adcetris Brentuximab vedotin Powder for injection: 50mg Hodgkin lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma
Libtayoa Cemiplimab Concentrate for infusion: 350mg/7mL Metastatic or locally advanced cutaneous squamous cell carcinoma
Ryzodeg 70/30b Insulin degludec FlexTouch solution for injection: 70U/mL
Penfill solution for injection: 70U/mL
Diabetes mellitus (for patients aged 6 years and older)
Brukinsaa Zanubrutinib Capsule: 80mg Waldenström's macroglobulinaemia, mantle cell lymphoma
Jivi Damoctocog alfa pegol Powder for injection: 250IU, 500IU, 1000IU, 2000IU, 3000IU Haemophilia A (congenital factor VIII deficiency)
Rybrevanta Amivantamab Concentrate for infusion: 350mg/7mL Locally advanced or metastatic non-small cell lung cancer
Jemperlia Dostarlimab Solution for infusion: 500mg/10mL Recurrent or advanced mismatch repair deficient endometrial cancer
  1. Provisional consent
  2. Ryzodeg 70/30 also contains 30 U/mL insulin aspart as an active ingredient

New indications

There were no approved medicines with new indications for additional therapeutic areas gazetted during the period 7 April 2023 to 13 July 2023.

More information

See the Medsafe website for:

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