Sondelbay

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teriparatide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 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 monitoringAdditional 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.

BiosimilarBiosimilar

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

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

24/03/2022 Sondelbay - EMEA/H/C/005827 -

Product information documents contain:

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.

Assessment history

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