This is a summary of the European public assessment report (EPAR) for Aclasta. 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 Aclasta.
Therapeutic Indication
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 and in men at increased risk of fracture. Treatment of Paget's disease of the bone.
Therapeutic Area (MeSH)
ATC Code
M05BA08
ATC Item
N/A
Pharmacotherapeutic Group
Drugs for treatment of bone diseases
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| zoledronic acid | N/A | zoledronic acid |
EMA Name
Aclasta
Medicine Name
Aclasta
Aliases
N/ANo risk management plan link.
