Ibandronic Acid Sandoz

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ibandronic acid

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 06/07/2022

Authorisation details

Product details
Name
Ibandronic Acid Sandoz
Agency product number
EMEA/H/C/002367
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Fractures, Bone
Anatomical therapeutic chemical (ATC) code
M05BA06
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Sandoz GmbH
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
26/07/2011
Contact address

Biochemiestrasse 10
6250 Kundl
Austria

Product information

06/07/2022 Ibandronic Acid Sandoz - EMEA/H/C/002367 - N/0021

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Drugs for treatment of bone diseases

  • Bisphosphonates

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

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