Zoledronic acid Teva Generics

zoledronic acid

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The marketing authorisation for Zoledronic Acid Teva Generics has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Zoledronic acid Teva Generics : EPAR - Summary for the public BG = bălgarski 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public ES = español 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public CS = čeština 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public DA = dansk 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public DE = Deutsch 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public ET = eesti keel 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public EL = elliniká 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public FR = français 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public IT = italiano 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public LV = latviešu valoda 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public LT = lietuvių kalba 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public HU = magyar 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public MT = Malti 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public NL = Nederlands 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public PL = polski 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public PT = português 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public RO = română 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public SK = slovenčina 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public SL = slovenščina 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public FI = suomi 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public SV = svenska 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Summary for the public HR = Hrvatski 2014-04-30 2016-08-08
Name Language First published Last updated
Zoledronic acid Teva Generics : EPAR - Risk-management-plan summary (English only) 2014-04-30 2016-08-08

This EPAR was last updated on 08/08/2016 .

Authorisation details

Product details

Product details for Zoledronic acid Teva Generics
NameZoledronic acid Teva Generics
Agency product numberEMEA/H/C/002805
Active substance

zoledronic acid monohydrate

International non-proprietary name (INN) or common name

zoledronic acid

Therapeutic area OsteoporosisOsteitis Deformans
Anatomical therapeutic chemical (ATC) code M05BA08
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Zoledronic acid Teva Generics
Marketing-authorisation holder

Teva Generics B.V

Revision2
Date of issue of marketing authorisation valid throughout the European Union27/03/2014

Contact address:

Teva Generics B.V
Computerweg 10 
Postbus 43028 
3540AA Utrecht 
The Netherlands

Product information

Product information

13/07/2015  Zoledronic acid Teva Generics -EMEA/H/C/002805 -IAIN/0002

Name Language First published Last updated
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - Product Information EN = English 2014-04-30 2016-08-08

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08
Zoledronic acid Teva Generics : EPAR - All Authorised presentations EN = English 2014-04-30 2016-08-08

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zoledronic acid Teva Generics : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2014-10-06 2016-08-08

Initial marketing-authorisation documents

Name Language First published Last updated
Zoledronic acid Teva Generics : EPAR - Public assessment report EN = English 2014-04-30 2016-08-08
CHMP summary of positive opinion for Zoledronic acid Teva Generics EN = English 2014-01-24  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Zoledronic acid Teva Generics