Reason for request

Renewal of inclusion on the list of medicines refundable by National Health Insurance.

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Clinical Benefit

Insufficient

Treatment of tumour-induced hypercalcaemia
Given that the 6 mg dosage is not appropriate for this indication as stated in the SPC, and in the absence of data provided by the company, the actual benefit of BONDRONAT 6 mg concentrate for solution for infusion in this indication remains insufficient.

Substantial

Prevention of bone complications in patients with breast cancer and bone metastases
The actual benefit of BONDRONAT 6 mg concentrate for solution for infusion in this indication remains substantial in the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.


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