Zometa (zoledronic acid)
- Region
- 🇪🇺 EU
- Active substance
- zoledronic acid
- Company
- Phoenix Labs Unlimited Company
- Status
- Authorised
- Therapeutic area
- Cancer; Fractures, Bone
- CHMP opinion
- Thu 14 Dec 2000
- EU approval
- Tue 20 Mar 2001
- Application
- EMEA/H/C/000336
- ATC
- M05BA08
- Official record
- www.ema.europa.eu
Indication
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); 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).
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- 🇪🇺 Zoledronic acid Actavis Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Zoledronic acid medac Withdrawn · medac Gesellschaft für klinische Spezialpräparate mbH
- 🇪🇺 Zoledronic Acid Hospira Withdrawn · Pfizer Europe MA EEIG
- 🇪🇺 Aclasta Authorised · Sandoz Pharmaceuticals d.d.
- 🇪🇺 Zoledronic Acid Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Zoledronic acid Teva Pharma Withdrawn · Teva B.V.
- 🇪🇺 Zoledronic acid Teva Generics Withdrawn · Teva Generics B.V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.