Zoledronic Acid Accord (zoledronic acid)
Generic
- Region
- 🇪🇺 EU
- Active substance
- zoledronic acid
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Hypercalcemia; Fractures, Bone; Cancer
- CHMP opinion
- Thu 21 Nov 2013
- EU approval
- Thu 16 Jan 2014
- Designations
- Generic
- Application
- EMEA/H/C/002667
- 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 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
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- 🇪🇺 Zoledronic acid Teva Pharma Withdrawn · Teva B.V.
- 🇪🇺 Zoledronic acid Teva Generics Withdrawn · Teva Generics B.V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.