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EMA Product

Zometa

Product approved by European Medicines Agency (EU)

Basic Information

Zometa

Regulatory Information

EMEA/H/C/000336

Authorised

March 20, 2001

December 14, 2000

39

October 29, 2024

Company Information

Ireland

Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath,

Phoenix Labs

Active Substances Detail

zoledronic acidzoledronic acid monohydrate

Detailed Information

Therapeutic Indication

### Therapeutic indication - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; - treatment of tumour-induced hypercalcaemia (TIH); - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; - treatment of tumour-induced hypercalcaemia (TIH); - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; - treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Overview Summary

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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