Medicinal Products
Dail Éireann — 2025-11-20
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Jennifer Carroll MacNeill (FG), Dún Laoghaire

I thank the Deputy for raising this case. He is right that this drug is reimbursed for postmenopausal women with osteoporosis. I would like an opportunity to check this but, as I understand it, the European Medicines Agency, EMA, originally assessed the drug for use in both women and men. However, the company withdrew the male indication during the process following concern over the benefit-risk profile. It has been added to the HSE reimbursement list for postmenopausal women at high risk of fracture but it is not licensed for use in men for that reason. As prescribing it for men would be off-label, the HSE does not extend reimbursement to male patients. There is no licence to use it to treat osteoporosis in men. The company marketing the medicine withdrew the licence application for that use. I am sorry to tell the Deputy there is nothing I can do about that.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/dail/2025-11-20/debate/main
Retrieved: 2026-10-05T01:00:55+00:00
Sitting date: 2025-11-20