Zoledronic acid medac
zoledronic acid
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac. 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 Zoledronic acid medac.
Authorisation details
Product details | |
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Name |
Zoledronic acid medac
|
Agency product number |
EMEA/H/C/002359
|
Active substance |
zoledronic acid monohydrate
|
International non-proprietary name (INN) or common name |
zoledronic acid
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
M05BA08
|
Generic |
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 | |
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Marketing-authorisation holder |
medac Gesellschaft für klinische Spezialpräparate mbH
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
03/08/2012
|
Contact address |
Product information
23/09/2020 Zoledronic acid medac - EMEA/H/C/002359 - IB/0030
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 adult patients with advanced malignancies involving bone.
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).