Bondenza (previously Ibandronic Acid Roche)
Withdrawn
This medicine's authorisation has been withdrawn
ibandronic acid
MedicineHumanWithdrawn
Overview
The marketing authorisation for Bondenza has been withdrawn at the request of the marketing authorisation holder.
Bondenza : EPAR - Summary for the public
English (EN) (563.91 KB - PDF)
First published: Last updated:
български (BG) (652.81 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
español (ES) (567.59 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
čeština (CS) (631.04 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
dansk (DA) (563.97 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Deutsch (DE) (567.08 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
eesti keel (ET) (563.49 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
ελληνικά (EL) (659.1 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
français (FR) (568.28 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
italiano (IT) (564.92 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
latviešu valoda (LV) (669.16 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
lietuvių kalba (LT) (591.9 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
magyar (HU) (627.12 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Malti (MT) (648.18 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Nederlands (NL) (567.18 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
polski (PL) (631.49 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
português (PT) (568.59 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
română (RO) (590.66 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
slovenčina (SK) (630.75 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
slovenščina (SL) (619.77 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Suomi (FI) (567.23 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
svenska (SV) (565.28 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Product information
Bondenza : EPAR - Product Information
English (EN) (1.11 MB - PDF)
First published: Last updated:
български (BG) (2.55 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
español (ES) (1.14 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
čeština (CS) (1.92 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
dansk (DA) (1.14 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
Deutsch (DE) (1.08 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
eesti keel (ET) (1.04 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
ελληνικά (EL) (2.52 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
français (FR) (1.08 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
íslenska (IS) (1.05 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
italiano (IT) (1.06 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
latviešu valoda (LV) (2.05 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
lietuvių kalba (LT) (1.27 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
magyar (HU) (1.88 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
Malti (MT) (2.01 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
Nederlands (NL) (1.13 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
norsk (NO) (1.13 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
polski (PL) (1.94 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
português (PT) (1.26 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
română (RO) (1.24 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
slovenčina (SK) (1.92 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
slovenščina (SL) (1.85 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
Suomi (FI) (1.05 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
svenska (SV) (1.12 MB - PDF)
First published: 04/09/2009Last updated: 13/05/2013
Latest procedure affecting product information: II/0034
15/11/2012
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).
Bondenza : EPAR - All Authorised presentations
English (EN) (477.15 KB - PDF)
First published: Last updated:
български (BG) (570.06 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
español (ES) (477.8 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
čeština (CS) (560.02 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
dansk (DA) (477.58 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Deutsch (DE) (477.71 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
eesti keel (ET) (478.18 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
ελληνικά (EL) (561.13 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
français (FR) (478.24 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
italiano (IT) (476.74 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
latviešu valoda (LV) (558.83 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
lietuvių kalba (LT) (545.31 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
magyar (HU) (556.04 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Malti (MT) (561.81 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Nederlands (NL) (476.95 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
polski (PL) (560.05 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
português (PT) (477.51 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
română (RO) (546.57 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
slovenčina (SK) (555.85 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
slovenščina (SL) (489.09 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
Suomi (FI) (477.42 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
svenska (SV) (477.35 KB - PDF)
First published: 20/03/2009Last updated: 13/05/2013
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.
Authorisation details
- EMA product number
- EMEA/H/C/000502
- Marketing authorisation holder
- Roche Registration Ltd.
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom - Marketing authorisation issued
- 23/02/2004
- Revision
- 16
Assessment history
Bondenza : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (726.29 KB - PDF)
First published: Last updated:
Bondenza-H-C-502-A20-25 : EPAR - Assessment Report – Article 20
AdoptedReference Number: EMA/543433/2011
English (EN) (665.37 KB - PDF)
First published: Last updated:
Bondenza-H-C-502-II-22 : EPAR - Scientific Discussion - Variation
Adopted
English (EN) (562.31 KB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Bondenza
AdoptedReference Number: EMA/821569/2009
English (EN) (502.04 KB - PDF)
First published: Last updated:
Bondenza : EPAR - Procedural steps taken before authorisation
English (EN) (544.75 KB - PDF)
First published: Last updated:
News on Bondenza (previously Ibandronic Acid Roche)
More information on Bondenza
Public statement on Bondenza: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/276528/2013
English (EN) (83.74 KB - PDF)
First published: Last updated:
This page was last updated on