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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 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" May,2025
Berotralstat Orladeyo 4.8 Undesirable effect May,2025
Diphenhydramine hydrochloride,dextromethorphan hydrobromide,pseudoephedrine hydrochloride Mentex 4.4 Special warnings and precautions for use May,2025
Risankizumab Skyrizi 4.6 Fertility, pregnancy and lactation May,2025
Gemcitabine Gemzar 4.8 Undesirable effect May,2025
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