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.
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.
Therapeutic Area (MeSH)
N/AATC Code
M05BA08
ATC Item
zoledronic acid
Pharmacotherapeutic Group
Drugs for treatment of bone diseases
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| zoledronic acid monohydrate | N/A | 唑来膦酸 |
EMA Name
Zoledronic Acid Hospira
Medicine Name
Zoledronic Acid Hospira
Aliases
N/ANo risk management plan link.
