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VMD in-depth assessment confirms continued positive benefit-risk balance for Librela.
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
Change to the information provided on adverse events in the Summary of Product Characteristics (SPC).
Change to the information provided in the Summary of Product Characteristics for Bioestrovet Swine 0.0875 mg/ml Solution for Injection for Pigs.
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