Qutavina
teriparatide
Table of contents
Overview
The marketing authorisation for Qutavina has been withdrawn at the request of the marketing-authorisation holder.
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List item
Qutavina : EPAR - Medicine overview (PDF/726.88 KB)
First published: 18/01/2021
EMA/349913/2020 -
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Qutavina : EPAR - Risk-management-plan summary (PDF/650.67 KB)
First published: 18/01/2021
Authorisation details
| Product details | |
|---|---|
| Name |
Qutavina
|
| Agency product number |
EMEA/H/C/005388
|
| Active substance |
teriparatide
|
| International non-proprietary name (INN) or common name |
teriparatide
|
| Therapeutic area (MeSH) |
Osteoporosis
|
| Anatomical therapeutic chemical (ATC) code |
H05AA02
|
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
EuroGenerics Holdings B.V.
|
| Date of issue of marketing authorisation valid throughout the European Union |
27/08/2020
|
| Contact address |
Locatellikade 1 |
Product information
24/11/2020 Qutavina - EMEA/H/C/005388 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Calcium homeostasis
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.