Sondelbay (teriparatide)
- Region
- 🇪🇺 EU
- Active substance
- teriparatide
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Osteoporosis
- CHMP opinion
- Thu 27 Jan 2022
- EU approval
- Thu 24 Mar 2022
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/005827
- ATC
- H05AA02
- Official record
- www.ema.europa.eu
Indication
Sondelbay is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Yorvipath Authorised · Ascendis Pharma Bone Diseases A/S
- 🇪🇺 Kauliv Authorised · Strides Pharma (Cyprus) Limited
- 🇪🇺 Zandoriah Authorised · CinnaGen Co Unipessoal LDA
- 🇪🇺 Terrosa Authorised · Gedeon Richter Plc.
- 🇪🇺 Movymia Authorised · STADA Arzneimittel AG
- 🇪🇺 Forsteo Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Livogiva Authorised · Theramex Ireland Limited
- 🇪🇺 Teriparatide Sun Authorised · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Teriparatide Ascend Application withdrawn · Ascend GmbH
- 🇪🇺 Teriparatide Cinnagen Application withdrawn · CinnaGen Co Unipessoal LDA
- 🇪🇺 Qutavina Withdrawn · EuroGenerics Holdings B.V.
- 🇪🇺 Sondelbay Application withdrawn · Accord Healthcare S.L.U.
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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.