Forsteo

RSS

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 13/11/2020

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
22
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

14/10/2020 Forsteo - EMEA/H/C/000425 - IB/0055

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating