Bondenza (previously Ibandronic Acid Roche)

Withdrawn

This medicine's authorisation has been withdrawn

ibandronic acid

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decision, the European public assessment report for Bondenza is updated to reflect that the marketing authorisation is no longer valid.

Bondenza : EPAR - Summary for the public

Product information

Bondenza : EPAR - Product Information

Bondenza : EPAR - All Authorised presentations

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000502
• Marketing authorisation holder:
  Roche Registration Ltd.

  6 Falcon Way; Shire Park; Welwyn Garden City AL7 1TW; United Kingdom

• Marketing authorisation issued:
  23/02/2004
• Withdrawal of marketing authorisation:
  14/02/2013
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

Bondenza : EPAR - Procedural steps taken and scientific information after authorisation

Bondenza-H-C-502-A20-25 : EPAR - Assessment Report – Article 20

Adopted Reference Number: EMA/543433/2011

Bondenza-H-C-502-II-22 : EPAR - Scientific Discussion - Variation

Adopted

CHMP post-authorisation summary of positive opinion for Bondenza

Adopted Reference Number: EMA/821569/2009

Initial marketing authorisation documents

Bondenza : EPAR - Procedural steps taken before authorisation