Published: 7 September 2023
Publications
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 |
- Provisional consent
- 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:
