Bondenza (previously Ibandronic Acid Roche)
ibandronic acid
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Bondenza has been withdrawn at the request of the marketing authorisation holder.
This EPAR was last updated on 13/05/2013
Authorisation details
| Product details | |
|---|---|
| Name |
Bondenza (previously Ibandronic Acid Roche)
|
| Agency product number |
EMEA/H/C/000502
|
| Active substance |
ibandronic acid
|
| International non-proprietary name (INN) or common name |
ibandronic acid
|
| Therapeutic area (MeSH) |
Osteoporosis, Postmenopausal
|
| Anatomical therapeutic chemical (ATC) code |
M05BA06
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Roche Registration Ltd.
|
| Revision |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/02/2004
|
| Contact address | |
Product information
15/11/2012 Bondenza (previously Ibandronic Acid Roche) - EMEA/H/C/000502 - II/0034
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Drugs for treatment of bone diseases
Therapeutic indication
Therapeutic indication
Treatment of osteoporosis in post-menopausal women at increased risk of fracture.
A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.