Zometa

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 15/04/2021

Authorisation details

Product details
Name
Zometa
Agency product number
EMEA/H/C/000336
Active substance
  • zoledronic acid
  • zoledronic acid monohydrate
International non-proprietary name (INN) or common name
zoledronic acid
Therapeutic area (MeSH)
  • Cancer
  • Fractures, Bone
Anatomical therapeutic chemical (ATC) code
M05BA08
Publication details
Marketing-authorisation holder
Phoenix Labs Unlimited Company
Revision
35
Date of issue of marketing authorisation valid throughout the European Union
20/03/2001
Contact address

Suite 12, Bunkilla Plaza,
Bracetown Business Park,
Clonee, County Meath,
Ireland

Product information

26/03/2021 Zometa - EMEA/H/C/000336 - T/0098

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

  • Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;
  • treatment of tumour-induced hypercalcaemia (TIH);
  • prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;
  • treatment of tumour-induced hypercalcaemia (TIH);
  • prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;
  • treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Assessment history

Changes since initial authorisation of medicine

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