Basic Information
Zoledronic Acid Hospira
Regulatory Information
EMEA/H/C/002365
November 19, 2012
18
November 9, 2021
Company Information
Belgium
Boulevard de la Plaine 17 1050 Bruxelles
Pfizer Europe MA EEIG
Drug Classification
Active Substances Detail
zoledronic acid monohydrate
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **4 mg / 5 ml and 4 mg / 100 ml:** - 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). **5 mg / 100 ml:** Treatment of osteoporosis: - in post-menopausal women; - in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: - in post-menopausal women; - in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Zoledronic Acid Hospira. 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 Hospira.