Published: 6 June 2024
Publications
Recent approvals: new active ingredients or new indications
Published: 6 June 2024
Prescriber Update 45(2): 39
June 2024
New active ingredients
Table 1 shows recent approvals of medicines with new active ingredients
gazetted during the period 2 February 2024 to 18 April 2024.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Zolgensma | Onasemnogene abeparvovec | Solution for infusion: 20TVG/mL 5.5mL vial, 8.3mL vial | Paediatric patients with spinal muscular atrophy |
| Scemblix | Asciminib | Film-coated tablet: 20mg, 40mg | Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase |
| Columvi* | Glofitamab | Concentrate for infusion: 10mg/10mL, 2.5mg/2.5mL | Adult patients with relapsed or refractory diffuse large B-cell lymphoma |
| Arexvy | Recombinant respiratory syncytial virus (RSV) pre-fusion F protein | Suspension for injection: 120mcg | Prevention of lower respiratory tract disease caused by RSV-A and RSV-B subtypes in adults aged ≥60 years |
* Provisional consent
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 2 February 2024 to 18 April 2024.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form: strength(s) | New therapeutic area |
|---|---|---|
| Keytruda (pembrolizumab) | Concentrate for infusion: 25mg/mL | Human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma |
More information
See the Medsafe website for:
