Kauliv (teriparatide)
- Region
- 🇪🇺 EU
- Active substance
- teriparatide
- Company
- Strides Pharma (Cyprus) Limited
- Status
- Authorised
- Therapeutic area
- Osteoporosis; Osteoporosis, Postmenopausal
- CHMP opinion
- Thu 10 Nov 2022
- EU approval
- Thu 12 Jan 2023
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004932
- ATC
- H05AA02
- Official record
- www.ema.europa.eu
Indication
Kauliv is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral 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 (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Teriparatide Ascend Application withdrawn · Ascend GmbH
- 🇪🇺 Teriparatide Cinnagen Application withdrawn · CinnaGen Co Unipessoal LDA
- 🇪🇺 Qutavina Withdrawn · EuroGenerics Holdings B.V.
- 🇪🇺 Sondelbay Application withdrawn · Accord Healthcare S.L.U.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.