Zoledronic acid Mylan (zoledronic acid)
Generic
- Region
- 🇪🇺 EU
- Active substance
- zoledronic acid
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Fractures, Bone
- EU approval
- Thu 23 Aug 2012
- Designations
- Generic
- Application
- EMEA/H/C/002482
- 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- 🇪🇺 Zoledronic acid Teva Generics Withdrawn · Teva Generics B.V
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