Ibandronic Acid Sandoz

Lapsed

This medicine's authorisation has lapsed

ibandronic acid

Overview

On 9 January 2024, the marketing authorisation of Ibandronic acid Sandoz (ibandronic acid) ceased to be valid in the European Union (EU).

The cessation of validity is due to the fact that the marketing authorisation holder, Sandoz GmbH, permanently discontinued marketing of Ibandronic acid Sandoz in the European Union (EU) in August 2017. In accordance with provisions of the sunset clause*, the marketing authorisation of a medicinal product lapses if the product had not been marketed in any EU Member States for three consecutive years.

Sandoz GmbH confirmed that it discontinued the marketing of the product due to commercial reasons.

Ibandronic acid Sandoz was granted marketing authorisation in the EU on 26 July 2011 for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016.

Ibandronic acid Sandoz is a generic medicine of Bondronat. There are other generic medicinal products of Bondronat authorised and marketed in the EU.

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*Article 14(5) of Regulation (EC) No 726/2004 ("sunset clause")

Ibandronic Acid Sandoz : EPAR - Summary for the public

Product information

Ibandronic acid Sandoz : EPAR - Product Information

Ibandronic acid Sandoz : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ibandronic Acid Sandoz
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002367
• Generic:

  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.

• Marketing authorisation holder:
  Sandoz GmbH

  Biochemiestrasse 10; 6250 Kundl; Austria

• Opinion adopted:
  17/02/2011
• Marketing authorisation issued:
  26/07/2011
• Lapse of marketing authorisation:
  09/01/2024
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Ibandronic acid Sandoz : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Ibandronic acid Sandoz : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/94879/2011

CHMP summary of positive opinion for Ibandronic Acid Sandoz

Adopted Reference Number: EMA/112994/2011