Zoledronic acid Teva Generics


zoledronic acid

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Zoledronic Acid Teva Generics has been withdrawn at the request of the marketing-authorisation holder.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

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 Generics B.V
Date of issue of marketing authorisation valid throughout the European Union
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

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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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