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The CHMPin light of the data submitted and the scientific discussion within the Committeewas of the opinion that the SmPCslabelling and package leaflets should be harmonised across the EU.
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In postmenopausal womenAdjuvant treatment of hormone receptor positive early breast cancerExtended adjuvant treatment of early breast cancer after 5 years of adjuvant tamoxifen therapyFirst-line treatment of hormone receptor positive or unknownlocally advanced or metastatic breast cancerTreatment of advanced breast cancer with disease progression following antiestrogen therapy.
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