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Novartis withdraws zoledronic acid marketing application


The European Medicines Agency has announced that it has been notified by Novartis Pharma that it wishes to withdraw the application to extend the marketing authorisation of zoledronic acid (Zometa) to include prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.

According to the EMEA, the company states that the withdrawal of the application was based on the Committee for Medicinal Products for Human Use (CHMP’s) consideration that the data provided did not allow them to recommend authorisation of the extension of indication.

More information about the state of the scientific assessment at the time of withdrawal of the new indication will be made available in a question-and-answer document that will be published on the EMEA website after the next meeting of the CHMP in December.

European Medicines Agency

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