Zoledronic acid Teva Pharma

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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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Zoledronic acid Teva Pharma has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 12/12/2018

Authorisation details

Product details
Name
Zoledronic acid Teva Pharma
Agency product number
EMEA/H/C/002437
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
15/08/2012
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

18/01/2018 Zoledronic acid Teva Pharma - EMEA/H/C/002437 - R/0014

Contents

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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.

Assessment history

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