Zoledronic acid Teva Pharma

Withdrawn

This medicine's authorisation has been withdrawn

zoledronic acid

Overview

On 18 January 2018 the European Commission withdrew the marketing authorisation for Zoledronic acid Teva Pharma (zoledronic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Zoledronic acid Teva Pharma was granted marketing authorisation in the EU on 16 August 2012 for treatment of osteoporosis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. 

Zoledronic acid Teva Pharma is a generic medicine of Aclasta. There are other generic medicines of Aclasta authorised and marketed in the EU. 

The European public assessment report (EPAR) for Zoledronic acid Teva Pharma is updated to reflect the fact that the marketing authorisation is no longer valid.

Zoledronic acid Teva Pharma : EPAR - Summary for the public

Reference Number: EMA/227536/2012

Product information

Zoledronic acid Teva Pharma : EPAR - Product Information

Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Zoledronic acid Teva Pharma
• Active substance:
  zoledronic acid
• International non-proprietary name (INN) or common name:
  zoledronic acid
• Therapeutic area (MeSH):
  • Osteoporosis
  • Osteitis Deformans
  • Osteoporosis, Postmenopausal
• Anatomical therapeutic chemical (ATC) code:
  M05BA08

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Treatment of osteoporosis:

• in post-menopausal women;
• in men;

at increased risk of fracture including those with a recent low-trauma hip fracture.

Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:

• in post-menopausal women;
• in men;

at increased risk of fracture.

Treatment of Paget’s disease of the bone in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/002437
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Marketing authorisation issued:
  15/08/2012
• Withdrawal of marketing authorisation:
  18/01/2018
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

Zoledronic acid Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Zoledronic acid Teva Pharma : EPAR - Public assessment report

Reference Number: EMA/534119/2012

CHMP summary of positive opinion for Zoledronic acid Teva Pharma

AdoptedReference Number: EMA/176371/2012