Forsteo

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teriparatide

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 20/01/2022

Authorisation details

Product details
Name
Forsteo
Agency product number
EMEA/H/C/000425
Active substance
teriparatide
International non-proprietary name (INN) or common name
teriparatide
Therapeutic area (MeSH)
  • Osteoporosis
  • Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
H05AA02
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
10/06/2003
Contact address

Eli Lilly Nederland BV
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

19/01/2022 Forsteo - EMEA/H/C/000425 - N/0060

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

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 nonvertebral 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.

Assessment history

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