Health Products Regulatory Authority

National register of authorized medicines in the Republic of Ireland.

Documents

Documents published by the Health Products Regulatory Authority, containing at least one indication involving a biomarker.

Name Indications Statements
Arimidex (anastrozole) [summary of product characteristics]. HPRA. 3 9
Aromasin (exemestane) [summary of product characteristics]. HPRA. 1 1
Femara (letrozole) [summary of product characteristics]. HPRA. 4 12

Regulatory approvals

Approved indications from the Health Products Regulatory Authority for cancer drugs containing at least one biomarker.

Document Indication Statements
Arimidex (anastrozole) [summary of product characteristics]. HPRA. Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. 3
Arimidex (anastrozole) [summary of product characteristics]. HPRA. Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women. 3
Arimidex (anastrozole) [summary of product characteristics]. HPRA. Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. 3
Aromasin (exemestane) [summary of product characteristics]. HPRA. Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy. 1
Femara (letrozole) [summary of product characteristics]. HPRA. Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. 3
Femara (letrozole) [summary of product characteristics]. HPRA. Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. 3
Femara (letrozole) [summary of product characteristics]. HPRA. First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer. 3
Femara (letrozole) [summary of product characteristics]. HPRA. 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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from Health Products Regulatory Authority's regulatory approvals.

Filter by organization:
Organization(s) Biomarker(s) Cancer type Therapy(ies)
HPRA (3) HSE (3) ER positive, PR positive Invasive Breast Carcinoma Letrozole
HPRA (3) HSE (3) ER positive Invasive Breast Carcinoma Letrozole
HPRA (3) HSE (3) PR positive Invasive Breast Carcinoma Letrozole
HPRA (1) HSE (1) ER positive Invasive Breast Carcinoma Exemestane
HPRA (3) HSE (1) ER positive Invasive Breast Carcinoma Anastrozole
HPRA (3) HSE (1) PR positive Invasive Breast Carcinoma Anastrozole
HPRA (3) HSE (1) ER positive, PR positive Invasive Breast Carcinoma Anastrozole
HPRA (1) ER positive, HER2-negative Invasive Breast Carcinoma Letrozole
HPRA (1) HER2-negative, PR positive Invasive Breast Carcinoma Letrozole
HPRA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Letrozole