Zoledronic acid Teva Generics
zoledronic acid
Table of contents
Overview
The marketing authorisation for Zoledronic Acid Teva Generics has been withdrawn at the request of the marketing-authorisation holder.
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List item
Zoledronic acid Teva Generics : EPAR - Summary for the public (PDF/541.61 KB)
First published: 30/04/2014
Last updated: 08/08/2016
EMA/60227/2014 -
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List item
Zoledronic acid Teva Generics : EPAR - Risk-management-plan summary (PDF/538.9 KB)
First published: 30/04/2014
Last updated: 08/08/2016
EMA/77822/2014
Authorisation details
| Product details | |
|---|---|
| Name |
Zoledronic acid Teva Generics
|
| Agency product number |
EMEA/H/C/002805
|
| Active substance |
zoledronic acid monohydrate
|
| International non-proprietary name (INN) or common name |
zoledronic acid
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
M05BA08
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva Generics B.V
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
27/03/2014
|
| 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
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).
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.