Ibandronic Acid Sandoz

ibandronic acid

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This is a summary of the European public assessment report (EPAR) for Ibandronic Acid Sandoz. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ibandronic Acid Sandoz.

What is Ibandronic Acid Sandoz?

Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid. It is available as tablets (50 mg).

Ibandronic Acid Sandoz is a ‘generic medicine’. This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine’ already authorised in the European Union (EU). The reference medicine for Ibandronic Acid Sandoz is Bondronat.

What is Ibandronic Acid Sandoz used for?

Ibandronic Acid Sandoz is used to prevent ‘skeletal events’ (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).

The medicine can only be obtained with a prescription.

How is Ibandronic Acid Sandoz used?

The recommended dose is one tablet taken once a day. The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.

Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed. The patient must also not lie down for one hour after taking the tablets.

How does Ibandronic Acid Sandoz work?

The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate. It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

How has Ibandronic Acid Sandoz been studied?

Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine. Medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Ibandronic Acid Sandoz?

Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Ibandronic Acid Sandoz been approved?

The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP’s view was that, as for Bondronat, the benefit outweighs the identified risk. The Committee recommended that Ibandronic Acid Sandoz be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Ibandronic Acid Sandoz?

A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ibandronic Acid Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Ibandronic Acid Sandoz:

The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011.

For more information about treatment with Ibandronic Acid Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ibandronic Acid Sandoz : EPAR - Summary for the public BG = bălgarski 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public ES = español 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public CS = čeština 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public DA = dansk 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public DE = Deutsch 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public ET = eesti keel 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public EL = elliniká 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public EN = English 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public FR = français 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public IT = italiano 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public LV = latviešu valoda 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public LT = lietuvių kalba 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public HU = magyar 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public MT = Malti 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public NL = Nederlands 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public PL = polski 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public PT = português 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public RO = română 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public SK = slovenčina 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public SL = slovenščina 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public FI = suomi 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public SV = svenska 04/08/2011 19/06/2015
Ibandronic Acid Sandoz : EPAR - Summary for the public HR = Hrvatski 04/08/2011 19/06/2015

This EPAR was last updated on 22/04/2016 .

Authorisation details

Product details

Product details for Ibandronic Acid Sandoz
NameIbandronic Acid Sandoz
Agency product numberEMEA/H/C/002367
Active substance

ibandronic acid

International non-proprietary name (INN) or common name

ibandronic acid

Therapeutic area Neoplasm MetastasisBreast NeoplasmsFractures, Bone
Anatomical therapeutic chemical (ATC) code M05BA06
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Ibandronic Acid Sandoz
Marketing-authorisation holder

Sandoz GmbH

Revision6
Date of issue of marketing authorisation valid throughout the European Union26/07/2011

Contact address:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Product information

Product information

13/04/2016  Ibandronic Acid Sandoz -EMEA/H/C/002367 -R/0017

Name Language First published Last updated
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016
Ibandronic acid Sandoz : EPAR - Product Information HR = Hrvatski 04/08/2011 22/04/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  
Ibandronic acid Sandoz : EPAR - All Authorised presentations HR = Hrvatski 04/08/2011  

Pharmacotherapeutic group

Prevention of skeletal events

Therapeutic indication

Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Ibandronic Acid Sandoz : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 11/07/2014 22/04/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Ibandronic acid Sandoz : EPAR - Public assessment report HR = Hrvatski 04/08/2011  
CHMP summary of positive opinion for Ibandronic Acid Sandoz HR = Hrvatski 18/02/2011  

Authorised

This medicine is approved for use in the European Union

More information on Ibandronic Acid Sandoz