Zoledronic acid Teva Generics

Withdrawn

This medicine's authorisation has been withdrawn

zoledronic acid

Overview

On 13 July 2015 the European Commission withdrew the marketing authorisation for Zoledronic acid Teva Generics (zoledronic acid) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva Generics B.V, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Zoledronic acid Teva Generics was granted marketing authorisation in the EU on 27 March 2014 for the treatment of osteoporosis and Paget’s disease of the bone. The marketing authorisation was initially valid for a 5-year period. 

Zoledronic acid Teva Generics is a generic medicine of Aclasta. Zoledronic acid Teva Generics was a duplicate application to Zoledronic acid Teva Pharma, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Zoledronic acid Teva Pharma.

The European Public Assessment Report (EPAR) for Zoledronic acid Teva Generics is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Zoledronic acid Teva Generics : EPAR - Summary for the public

Reference Number: EMA/60227/2014

Zoledronic acid Teva Generics : EPAR - Risk-management-plan summary

Reference Number: EMA/77822/2014

Product information

Zoledronic acid Teva Generics : EPAR - Product Information

Zoledronic acid Teva Generics : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Bisphosphonates

Therapeutic indication

Treatment of osteoporosis

• in post-menopausal women
• in adult men

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

Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy

• in post-menopausal women
• in adult men

at increased risk of fracture.

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

Authorisation details

• EMA product number:
  EMEA/H/C/002805
• 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 Generics B.V

  Computerweg 10 ; Postbus 43028 ; 3540AA Utrecht ; The Netherlands

• Opinion adopted:
  23/01/2014
• Marketing authorisation issued:
  27/03/2014
• Withdrawal of marketing authorisation:
  13/07/2015
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Zoledronic acid Teva Generics : EPAR - Public assessment report

AdoptedReference Number: EMA/179093/2014

CHMP summary of positive opinion for Zoledronic acid Teva Generics

AdoptedReference Number: EMA/CHMP/25433/2014