Femara (letrozole) [summary of product characteristics]. HPRA.

Regulatory approval published by the Health Products Regulatory Authority.

Citation

Novartis Ireland Limited. Femara 2.5 mg film-coated tablets (Letrozole) [summary of product characteristics]. Health Products Regulatory Authority website. https://assets.hpra.ie/products/Human/22619/Licence_PA0896-012-001_30082024144429.pdf. Revised August 2024. Accessed May 25, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies