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 the EMA Committee for Medicinal Products for Human Use in May.
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.”