Zoledronic acid medac

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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 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.

This EPAR was last updated on 23/10/2019

Authorisation details

Product details
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)
  • Fractures, Bone
  • Cancer
Anatomical therapeutic chemical (ATC) code
M05BA08
GenericGeneric

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
Marketing-authorisation holder
medac Gesellschaft für klinische Spezialpräparate mbH
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
03/08/2012
Contact address
Fehlandtstraße 3
D-20354 Hamburg
Germany

Product information

24/09/2019 Zoledronic acid medac - EMEA/H/C/002359 - IB/0025/G

Contents

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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).

Assessment history

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