Zometa
zoledronic acid
Table of contents
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).
Authorisation details
Product details | |
---|---|
Name |
Zometa
|
Agency product number |
EMEA/H/C/000336
|
Active substance |
|
International non-proprietary name (INN) or common name |
zoledronic acid
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
M05BA08
|
Publication details | |
---|---|
Marketing-authorisation holder |
Phoenix Labs Unlimited Company
|
Revision |
36
|
Date of issue of marketing authorisation valid throughout the European Union |
20/03/2001
|
Contact address |
Suite 12, Bunkilla Plaza, |
Product information
04/06/2021 Zometa - EMEA/H/C/000336 - IAIN/0099/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).