Sondelbay
teriparatide
Table of contents
Overview
Sondelbay is a medicine used for the treatment of osteoporosis (a disease that makes the bones fragile) in:
- women who have been through the menopause;
- men who have an increased risk of fractures;
- men and women who have an increased risk of fracture due to long-term treatment with glucocorticoids (a type of steroid).
Sondelbay is a ‘biosimilar medicine’. This means that Sondelbay is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Sondelbay is Forsteo. For more information on biosimilar medicines, see here.
Sondelbay contains the active substance teriparatide.
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List item
Sondelbay : EPAR - Medicine overview (PDF/113.41 KB)
First published: 16/06/2022
EMA/65141/2022 -
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List item
Sondelbay : EPAR - Risk-management-plan summary (PDF/166.01 KB)
First published: 16/06/2022
Authorisation details
Product details | |
---|---|
Name |
Sondelbay
|
Agency product number |
EMEA/H/C/005827
|
Active substance |
teriparatide
|
International non-proprietary name (INN) or common name |
teriparatide
|
Therapeutic area (MeSH) |
Osteoporosis
|
Anatomical therapeutic chemical (ATC) code |
H05AA02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
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 |
Accord Healthcare S.L.U.
|
Date of issue of marketing authorisation valid throughout the European Union |
24/03/2022
|
Contact address |
Accord Healthcare S.L.U. |
Product information
24/03/2022 Sondelbay - EMEA/H/C/005827 -
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
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.