Basic Information
Zoledronic acid Actavis
Regulatory Information
EMEA/H/C/002488
April 20, 2012
February 16, 2012
15
June 1, 2023
Company Information
Iceland
Actavis Group PTC ehf Dalshraun 1 220 Hafnarfjörður
Actavis Group Ptc Ehf.
Drug Classification
Active Substances Detail
zoledronic acid monohydrate
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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis. 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 Actavis.