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Clinigen Group PLC (LON:CLIN) said the European Commission (EC) has approved an update to the product information for a key oncology product that would allow doctors to consider its use in children. The label change relates to Cardioxane, which is given to protect the heart against certain chemotherapies called anthracyclines. Its use was restricted in 2011. But, following extensive work by the Clinigen team, paediatric oncologists and cardiologists, the company was issued with a positive opinion by EMA Committee for Medicinal Products for Human Use in May. Major milestone Chief executive Shaun Chilton called the label change a “major regulatory achievement”. Merav Edan, head of regulatory Specialty Pharmaceuticals of Clinigen, added: “EC approval is the final step to ensuring that the paediatric oncologists can effectively manage cardiotoxicity associated with anthracycline chemotherapy by using Cardioxane when needed. “Not only that, the additional changes to the Cardioxane product information will extend its use in the adult population.”
Original Article: Clinigen hails EC label change for oncology drugNEXT ARTICLE
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