Zoledronic Acid Hospira

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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 Hospira. 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 Hospira.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Zoledronic Acid Hospira
Agency product number
EMEA/H/C/002365
Active substance
zoledronic acid monohydrate
International non-proprietary name (INN) or common name
zoledronic acid
Therapeutic area (MeSH)
Hypercalcemia
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
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
18/11/2012
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

19/09/2018 Zoledronic Acid Hospira - EMEA/H/C/002365 - T/0033

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

4 mg / 5 ml and 4 mg / 100 ml:

  • 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).

5 mg / 100 ml:

Treatment of osteoporosis:

  • in post-menopausal women;
  • in men;

at increased risk of fracture, including those with a recent low-trauma hip fracture.

Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:

  • in post-menopausal women;
  • in men;

at increased risk of fracture.

Treatment of Paget's disease of the bone in adults.

Assessment history

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