Prolia (denosumab)
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Bone Resorption; Osteoporosis, Postmenopausal; Osteoporosis
- EU approval
- Wed 26 May 2010
- Application
- EMEA/H/C/001120
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
Indication
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Enoby Approved · Hikma Pharmaceuticals Usa Inc
- 🇪🇺 Bildyos Authorised · Sciencepharma Sp. z o.o
- 🇪🇺 Jubereq Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Yaxwer Authorised · Gedeon Richter Plc.
- 🇪🇺 Vevzuo Authorised · Biosimilar Collaborations Ireland Limited
- 🇺🇸 Ponlimsi Approved · Teva Pharmaceuticals, Inc.
- 🇪🇺 Wyost Authorised · Sandoz GmbH
- 🇺🇸 Denosumab-Dssb Approved · Samsung Bioepis Co Ltd
- 🇪🇺 Denosumab Ascend Authorised · Ascend GmbH
- 🇪🇺 Denbrayce Authorised · Mabxience Research SL
- 🇪🇺 Degevma Authorised · Teva GmbH
- 🇪🇺 Xbonzy Authorised · Reddy Holding GmbH
Follow Prolia
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.