Iasibon

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 Iasibon. 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 Iasibon.

This EPAR was last updated on 10/05/2019

Authorisation details

Product details
Name
Iasibon
Agency product number
EMEA/H/C/002025
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
  • Hypercalcemia
  • Fractures, Bone
  • Neoplasm Metastasis
  • Breast Neoplasms
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
Pharmathen S.A.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
21/01/2011
Contact address
6, Dervenakion
EL-15351 Pallini Attiki
Greece

Product information

03/04/2019 Iasibon - EMEA/H/C/002025 - N/0020

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.

Pharmacotherapeutic group

DRUGS FOR TREATMENT OF BONE DISEASES

Therapeutic indication

Concentrate for solution for infusion
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.

Film-coated Tablets
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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