Overview

The marketing authorisation for Zoledronic acid Teva Pharma has been withdrawn at the request of the marketing authorisation holder.

Zoledronic acid Teva Pharma : EPAR - Summary for the public

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Product information

Zoledronic acid Teva Pharma : EPAR - Product Information

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Latest procedure affecting product information: R/0014

18/01/2018

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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

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slovenščina (SL) (537.91 KB - PDF)
Suomi (FI) (490.79 KB - PDF)
svenska (SV) (487.54 KB - PDF)

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
Revision
11

Assessment history

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

Zoledronic acid Teva Pharma : EPAR - Public assessment report

CHMP summary of positive opinion for Zoledronic acid Teva Pharma

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