Basic Information
Zoledronic acid Mylan
Regulatory Information
EMEA/H/C/002482
August 23, 2012
16
October 3, 2024
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin 15
MYLAN PHARMACEUTICALS PRIVATE LIMITED
Drug Classification
Active Substances Detail
EMA Resources
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 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) for Zoledronic acid Mylan. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Mylan.