Zoledronic acid Mylan

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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 Mylan. 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 Mylan.

This EPAR was last updated on 02/10/2019

Authorisation details

Product details
Name
Zoledronic acid Mylan
Agency product number
EMEA/H/C/002482
Active substance
zoledronic acid
International non-proprietary name (INN) or common name
zoledronic acid
Therapeutic area (MeSH)
Fractures, Bone
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
Mylan S.A.S.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
23/08/2012
Contact address
117 allée des Parcs
F-69 800 Saint Priest
France

Product information

29/08/2019 Zoledronic acid Mylan - EMEA/H/C/002482 - N/0018

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).

Assessment history

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