Bondenza (previously Ibandronic Acid Roche)

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Withdrawn

This medicine's authorisation has been withdrawn

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decision, the European public assessment report for Bondenza is updated to reflect that the marketing authorisation is no longer valid.

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magyar (HU) (627.12 KB - PDF)

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polski (PL) (631.49 KB - PDF)

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português (PT) (568.59 KB - PDF)

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română (RO) (590.66 KB - PDF)

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slovenčina (SK) (630.75 KB - PDF)

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slovenščina (SL) (619.77 KB - PDF)

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Suomi (FI) (567.23 KB - PDF)

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svenska (SV) (565.28 KB - PDF)

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Product information

български (BG) (2.55 MB - PDF)

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español (ES) (1.14 MB - PDF)

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čeština (CS) (1.92 MB - PDF)

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dansk (DA) (1.14 MB - PDF)

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Deutsch (DE) (1.08 MB - PDF)

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eesti keel (ET) (1.04 MB - PDF)

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ελληνικά (EL) (2.52 MB - PDF)

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français (FR) (1.08 MB - PDF)

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íslenska (IS) (1.05 MB - PDF)

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italiano (IT) (1.06 MB - PDF)

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latviešu valoda (LV) (2.05 MB - PDF)

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lietuvių kalba (LT) (1.27 MB - PDF)

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magyar (HU) (1.88 MB - PDF)

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Malti (MT) (2.01 MB - PDF)

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Nederlands (NL) (1.13 MB - PDF)

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norsk (NO) (1.13 MB - PDF)

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polski (PL) (1.94 MB - PDF)

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português (PT) (1.26 MB - PDF)

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română (RO) (1.24 MB - PDF)

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slovenčina (SK) (1.92 MB - PDF)

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slovenščina (SL) (1.85 MB - PDF)

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Suomi (FI) (1.05 MB - PDF)

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svenska (SV) (1.12 MB - PDF)

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Latest procedure affecting product information: II/0034
15/11/2012
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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).

български (BG) (570.06 KB - PDF)

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español (ES) (477.8 KB - PDF)

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čeština (CS) (560.02 KB - PDF)

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dansk (DA) (477.58 KB - PDF)

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Deutsch (DE) (477.71 KB - PDF)

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eesti keel (ET) (478.18 KB - PDF)

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ελληνικά (EL) (561.13 KB - PDF)

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français (FR) (478.24 KB - PDF)

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italiano (IT) (476.74 KB - PDF)

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latviešu valoda (LV) (558.83 KB - PDF)

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lietuvių kalba (LT) (545.31 KB - PDF)

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magyar (HU) (556.04 KB - PDF)

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Malti (MT) (561.81 KB - PDF)

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Nederlands (NL) (476.95 KB - PDF)

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polski (PL) (560.05 KB - PDF)

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português (PT) (477.51 KB - PDF)

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română (RO) (546.57 KB - PDF)

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slovenčina (SK) (555.85 KB - PDF)

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slovenščina (SL) (489.09 KB - PDF)

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Suomi (FI) (477.42 KB - PDF)

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svenska (SV) (477.35 KB - PDF)

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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

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