Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
---|---|---|---|---|
Rsv subgroup a stabilised prefusion f,rsv subgroup b stabilised prefusion f | Abrysvo | 4.5 Interaction with other medicinal products and other forms of interaction | Abrysvo can be administered concomitantly with COVID-19 mRNA vaccine, with or without high dose of influenza vaccine administered concomitantly | May,2025 |
Andexanet alfa | Andexxa | "4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.8 Undesirable effect" | Thromboembolic and ischemic risks, unresponsiveness to heparin | May,2025 |
Berotralstat | Orladeyo | 4.8 Undesirable effect | Nausea | May,2025 |
Diphenhydramine hydrochloride,dextromethorphan hydrobromide,pseudoephedrine hydrochloride | Mentex | 4.4 Special warnings and precautions for use | Posterior Reversible Encephalopathy Syndrome (PRES) | May,2025 |
Risankizumab | Skyrizi | 4.6 Fertility, pregnancy and lactation | IgG antibodies across the placenta | May,2025 |
Gemcitabine | Gemzar | 4.8 Undesirable effect | Sepsis (Rare), Thrombotic microangiopathy (very rare) | May,2025 |