Astrazeneca Receives European Positive Regulatory Recommendation

Astrazeneca said Friday that European drug regulators issued a positive recommendation for selling Faslodex, a breast cancer treatment. The opinion was made by the Committee for Medicinal Products for Human Use of the European Medicines Agency for the drug, which is indicated for hormone receptor-positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after anti-oestrogen therapy, or disease progression on anti-oestrogen therapy, Astra Zeneca said in a press release.

Following the positive opinion, the European Commission, which approves medicines for the European Union, will have the final say in approving the medicine. The final decision will be apply across all 28 EU member countries plus Iceland, Norway and Liechtenstein.

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