Aclasta

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zoledronic 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 Aclasta. 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 Aclasta.

This EPAR was last updated on 15/10/2018

Authorisation details

Product details
Name
Aclasta
Agency product number
EMEA/H/C/000595
Active substance
zoledronic acid
International non-proprietary name (INN) or common name
zoledronic acid
Therapeutic area (MeSH)
  • Osteoporosis
  • Osteitis Deformans
  • Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
M05BA08
Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
15/04/2005
Contact address
Novartis Europharm Limited
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

19/04/2018 Aclasta - EMEA/H/C/000595 - T/0070

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 post-menopausal women;
  • in men;

at increased risk of fracture, including those with a recent low-trauma hip fracture.

Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture.

Treatment of Paget's disease of the bone.

Assessment history

Changes since initial authorisation of medicine

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