Movymia

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) for Movymia. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Movymia.

For practical information about using Movymia, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/01/2022

Authorisation details

Product details
Name
Movymia
Agency product number
EMEA/H/C/004368
Active substance
teriparatide
International non-proprietary name (INN) or common name
teriparatide
Therapeutic area (MeSH)
Osteoporosis
Anatomical therapeutic chemical (ATC) code
H05AA02
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
STADA Arzneimittel AG
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
11/01/2017
Contact address

Stadastrasse 2-18
Bad Vilbel
Hessen
61118
Germany

Product information

12/01/2022 Movymia - EMEA/H/C/004368 - N/0028

Other EU languages available icon 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:

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

Movymia 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 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
Average
1 rating
1 rating