Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Filgrastim | Nivestim | "4.4 Special warnings and precautions for use, 4.8 Undesirable effect" | Myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) | Jul, 2025 |
| Exagamglogene Autotemcel | Casgevy | 4.4 Special warnings and precautions for use | Gene-editing related oncogenesis | Jul, 2025 |
| Dapoxetine | Priligy | 4.4 Special warnings and precautions for use | This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’ | Jun, 2025 |
| Daunorubicin,Cytarabine | Vyxeos | "4.4 Special warnings and precautions for use 4.6 Fertility, pregnancy and lactation" | "Cardiotoxicity Women of childbearing potential/Contraception in males and females" | Jun, 2025 |
| Mycophenolate Sodium | Resepta | "4.4 Special warnings and precautions for use 4.8 Undesirable effects 4.7 Effects on ability to drive and use machines" | "Sodium content ,Infections, Blood and lymphatic disorder , gastrointestinal disorder , Respiratory, thoracic and mediastinal disorders General disorders and administration site conditions, and updates in Summary of safety profile Mycophenolate Mofetil has a moderate influence on the ability to drive and use machines" | Jun, 2025 |
| 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 |