Zoledronic acid Teva Generics

Withdrawn

This medicine's authorisation has been withdrawn

zoledronic acid

Overview

The marketing authorisation for Zoledronic Acid Teva Generics has been withdrawn at the request of the marketing-authorisation holder.

Zoledronic acid Teva Generics : EPAR - Summary for the public

Reference Number: EMA/60227/2014

Zoledronic acid Teva Generics : EPAR - Risk-management-plan summary

Reference Number: EMA/77822/2014

Product information

Zoledronic acid Teva Generics : EPAR - Product Information

Latest procedure affecting product information: IAIN/0002

13/07/2015

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 Generics : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zoledronic acid Teva Generics
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002805
• 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 Generics B.V

  Computerweg 10 ; Postbus 43028 ; 3540AA Utrecht ; The Netherlands

• Opinion adopted:
  23/01/2014
• Marketing authorisation issued:
  27/03/2014
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Zoledronic acid Teva Generics : EPAR - Public assessment report

AdoptedReference Number: EMA/179093/2014

CHMP summary of positive opinion for Zoledronic acid Teva Generics

AdoptedReference Number: EMA/CHMP/25433/2014