Bonviva

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 Bonviva. 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 Bonviva.

This EPAR was last updated on 22/08/2018

Authorisation details

Product details
Name
Bonviva
Agency product number
EMEA/H/C/000501
Active substance
ibandronic acid
International non-proprietary name (INN) or common name
ibandronic acid
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
M05BA06
Publication details
Marketing-authorisation holder
Atnahs Pharma UK Limited
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
23/02/2004
Contact address
Sovereign House
Miles Gray Road
Basildon
SS14 3FR
United Kingdom

Product information

10/07/2018 Bonviva - EMEA/H/C/000501 - IAIN/0065/G

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

Treatment of osteoporosis in postmenopausal women at increased risk of fracture.

A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Assessment history

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