Aclasta (zoledronic acid)
- Region
- 🇪🇺 EU
- Active substance
- zoledronic acid
- Company
- Sandoz Pharmaceuticals d.d.
- Status
- Authorised
- Therapeutic area
- Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
- EU approval
- Fri 15 Apr 2005
- Application
- EMEA/H/C/000595
- ATC
- M05BA08
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zoledronic acid Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Zoledronic acid Teva Authorised · Teva B.V.
- 🇪🇺 Zoledronic acid Actavis Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Zoledronic acid medac Withdrawn · medac Gesellschaft für klinische Spezialpräparate mbH
- 🇪🇺 Zoledronic Acid Hospira Withdrawn · Pfizer Europe MA EEIG
- 🇪🇺 Zoledronic Acid Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Zometa Authorised · Phoenix Labs Unlimited Company
- 🇪🇺 Zoledronic acid Teva Pharma Withdrawn · Teva B.V.
- 🇪🇺 Zoledronic acid Teva Generics Withdrawn · Teva Generics B.V
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.