Qutavina

Withdrawn

This medicine's authorisation has been withdrawn

teriparatide

Overview

On 24 November 2020, the European Commission withdrew the marketing authorisation for Qutavina (teriparatide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, EuroGenerics Holdings B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Qutavina was granted marketing authorisation in the EU on 27 August 2020 for the treatment of osteoporosis. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2020. Qutavina was a duplicate application to Livogiva, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Livogiva.

The European Public Assessment Report (EPAR) for Qutavina is updated to indicate that the marketing authorisation is no longer valid.

Qutavina : EPAR - Medicine overview

Reference Number: EMA/349913/2020

Qutavina : EPAR - Risk-management-plan summary

Product information

Qutavina : EPAR - Product Information

Qutavina : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Qutavina
• Active substance:
  teriparatide
• International non-proprietary name (INN) or common name:
  teriparatide
• Therapeutic area (MeSH):
  Osteoporosis
• Anatomical therapeutic chemical (ATC) code:
  H05AA02

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005388
• Biosimilar:

  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.

• Marketing authorisation holder:
  EuroGenerics Holdings B.V.

  Locatellikade 1; 1076 AZ Amsterdam; The Netherlands

• Marketing authorisation issued:
  27/08/2020
• Withdrawal of marketing authorisation:
  24/11/2020

Assessment history

Initial marketing authorisation documents

Qutavina : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/379170/2020

CHMP summary of positive opinion for Qutavina

AdoptedReference Number: EMA/CHMP/341130/2020