Bondenza (previously Ibandronic Acid Roche)

RSS

ibandronic acid

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Bondenza has been withdrawn at the request of the marketing authorisation holder.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

Drugs for treatment of bone diseases

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.

Assessment history

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