- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 February 2004, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Bondenza, (ibandronic acid), which had been approved for treatment of osteoporosis in postmenopausal women at increased risk of fracture.
The marketing authorisation holder (MAH) responsible for Bondenza was Roche Registration Ltd. On 27 March 2013, the European Commission issued a decision to withdraw the marketing authorisation for Bondenza, following its receipt of a letter dated 14 February 2013 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons.
Bondenza 150 mg film-coated tablets (Bondenza tablets) were marketed in the following European countries: Spain Bondenza 3 mg solution for injection (Bondenza IV) was not marketed in any European country.
Pursuant to this decision, the European public assessment report for Bondenza is updated to reflect that the marketing authorisation is no longer valid.
Product information
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).
Product details
- Name of medicine
- Bondenza (previously Ibandronic Acid Roche)
- 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
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic 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.