Zometa: Withdrawal of the application to change the marketing authorisation

zoledronic acid


On 15 November 2007, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zometa, in the prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zometa (PDF/38.49 KB)

    First published: 17/01/2008
    Last updated: 17/01/2008

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • zoledronic acid
    Active substance
    • zoledronic acid
    • zoledronic acid monohydrate
    Date of withdrawal
    Company making the application
    Phoenix Labs Unlimited Company
    Withdrawal type

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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