Zoledronic acid Teva Pharma

Withdrawn

This medicine's authorisation has been withdrawn

zoledronic acid

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The marketing authorisation for Zoledronic acid Teva Pharma has been withdrawn at the request of the marketing authorisation holder.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

Reference Number: EMA/227536/2012

Product information

Zoledronic acid Teva Pharma : EPAR - Product Information

Latest procedure affecting product information: R/0014

18/01/2018

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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

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

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Zoledronic acid Teva Pharma : EPAR - Public assessment report

Reference Number: EMA/534119/2012

CHMP summary of positive opinion for Zoledronic acid Teva Pharma

AdoptedReference Number: EMA/176371/2012