On 24 November 2020, the European Commission withdrew the marketing authorisation for Qutavina (teriparatide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, EuroGenerics Holdings B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Qutavina was granted marketing authorisation in the EU on 27 August 2020 for the treatment of osteoporosis. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2020. Qutavina was a duplicate application to Livogiva, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Livogiva. The European Public Assessment Report (EPAR) for Qutavina is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
### Therapeutic indication Qutavina 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.
Therapeutic Area (MeSH)
ATC Code
H05AA02
ATC Item
teriparatide
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| teriparatide | N/A | 特立帕肽 |
EMA Name
Qutavina
Medicine Name
Qutavina
Aliases
N/A
