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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Bondenza has been withdrawn at the request of the marketing authorisation holder.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 |
Roche Registration Limited
6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom |
Product information
15/11/2012 Bondenza (previously Ibandronic Acid Roche) - EMEA/H/C/000502 - II/0034
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
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.