Zoledronic acid Teva Generics (zoledronic acid)
Generic
- Region
- 🇪🇺 EU
- Active substance
- zoledronic acid
- Company
- Teva Generics B.V
- Status
- Withdrawn
- Therapeutic area
- Osteoporosis; Osteitis Deformans
- CHMP opinion
- Thu 23 Jan 2014
- EU approval
- Thu 27 Mar 2014
- Designations
- Generic
- Application
- EMEA/H/C/002805
- ATC
- M05BA08
- Official record
- www.ema.europa.eu
Indication
Treatment of osteoporosis in post-menopausal women in adult men at increased risk of fracture, including those with recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women in adult men at increased risk of fracture. Treatment of Paget's disease of the bone in adults.
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.
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- 🇪🇺 Zoledronic acid medac Withdrawn · medac Gesellschaft für klinische Spezialpräparate mbH
- 🇪🇺 Zoledronic Acid Hospira Withdrawn · Pfizer Europe MA EEIG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.
- 🇪🇺 Zometa Authorised · Phoenix Labs Unlimited Company
- 🇪🇺 Zoledronic acid Teva Pharma Withdrawn · Teva B.V.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.