Zoledronic acid Teva Generics

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zoledronic acid

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zoledronic Acid Teva Generics has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 08/08/2016

Authorisation details

Product details
Name
Zoledronic acid Teva Generics
Agency product number
EMEA/H/C/002805
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
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 medicines.

Publication details
Marketing-authorisation holder
Teva Generics B.V
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
27/03/2014
Contact address
Computerweg 10
Postbus 43028
3540AA Utrecht
The Netherlands

Product information

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

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.

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

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