Qutavina

Withdrawn

This medicine's authorisation has been withdrawn

teriparatide

Overview

The marketing authorisation for Qutavina has been withdrawn at the request of the marketing-authorisation holder.

Qutavina : EPAR - Medicine overview

Reference Number: EMA/349913/2020

Qutavina : EPAR - Risk-management-plan summary

Product information

Qutavina : EPAR - Product Information

24/11/2020

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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

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