Bondronat

RSS

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 Bondronat. 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 Bondronat.

This EPAR was last updated on 03/06/2019

Authorisation details

Product details
Name
Bondronat
Agency product number
EMEA/H/C/000101
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
  • Hypercalcemia
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Fractures, Bone
Anatomical therapeutic chemical (ATC) code
M05BA06
Publication details
Marketing-authorisation holder
Atnahs Pharma Netherlands B.V.
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
25/06/1996
Contact address

Strawinskylaan 3127
1077 ZX Amsterdam
Netherlands

Product information

20/05/2018 Bondronat - EMEA/H/C/000101 - T/0082

Contents

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

Pharmacotherapeutic group

DRUGS FOR TREATMENT OF BONE DISEASES

Therapeutic indication

Bondronat is indicated for:

  • prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases;
  • treatment of tumour-induced hypercalcaemia with or without metastases.

Assessment history

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