Forsteo (teriparatide)
- Region
- 🇪🇺 EU
- Active substance
- teriparatide
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Osteoporosis; Osteoporosis, Postmenopausal
- CHMP opinion
- Wed 19 Mar 2003
- EU approval
- Tue 10 Jun 2003
- Application
- EMEA/H/C/000425
- ATC
- H05AA02
- Official record
- www.ema.europa.eu
Indication
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 nonvertebral fractures but not hip fractures has 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
- 🇪🇺 Sondelbay Authorised · Accord Healthcare S.L.U.
- 🇪🇺 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- 🇪🇺 Teriparatide Ascend Application withdrawn · Ascend GmbH
- 🇪🇺 Teriparatide Cinnagen Application withdrawn · CinnaGen Co Unipessoal LDA
- 🇪🇺 Qutavina Withdrawn · EuroGenerics Holdings B.V.
- 🇪🇺 Sondelbay Application withdrawn · Accord Healthcare S.L.U.
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