Qutavina

RSS

teriparatide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Qutavina has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 18/01/2021

Authorisation details

Product details
Name
Qutavina
Agency product number
EMEA/H/C/005388
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
EuroGenerics Holdings B.V.
Date of issue of marketing authorisation valid throughout the European Union
27/08/2020
Contact address

Locatellikade 1
1076 AZ Amsterdam
The Netherlands

Product information

24/11/2020 Qutavina - EMEA/H/C/005388 -

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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

Qutavina 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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