Zoledronic acid Teva Pharma

zoledronic acid

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This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Pharma. 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 Teva Pharma.

What is Zoledronic acid Teva Pharma?

Zoledronic acid Teva Pharma is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid (5 mg).

Zoledronic acid Teva Pharma is a ‘generic medicine’. This means that Zoledronic acid Teva Pharma is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aclasta.

What is Zoledronic acid Teva Pharma used for?

Zoledronic acid Teva Pharma is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men. It is used in patients who are at risk of fractures (broken bones), including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).

Zoledronic acid Teva Pharma is also used to treat Paget’s disease of the bone in adults. This is a disease where the normal process of bone growth is changed.

The medicine can only be obtained with a prescription.

How is Zoledronic acid Teva Pharma used?

Zoledronic acid Teva Pharma is given as an infusion lasting at least 15 minutes. This can be repeated once a year in patients being treated for osteoporosis. Patients who have broken their hip should not receive Zoledronic acid Teva Pharma any earlier than two weeks after the operation to repair the fracture.

For Paget’s disease, only one infusion of Zoledronic acid Teva Pharma is usually given, but additional infusions can be considered if the patient’s disease comes back. The effect of each infusion lasts for a year or more.

Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium. Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Zoledronic acid Teva Pharma can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion. In the treatment of Paget’s disease of the bone, Zoledronic acid Teva Pharma must only be used by a doctor who has experience in the treatment of the disease. Zoledronic acid Teva Pharma should not be used in patients with severe kidney problems. See the package leaflet for full details.

How does Zoledronic acid Teva Pharma work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to fracture. In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall. Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment. In Paget’s disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.

The active substance in Zoledronic acid Teva Pharma, zoledronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss in osteoporosis and less disease activity in Paget’s disease.

How has Zoledronic acid Teva Pharma been studied?

No additional studies were needed as Zoledronic acid Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.

What are the benefits and risks of Zoledronic acid Teva Pharma?

Because Zoledronic acid Teva Pharma is a generic, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Zoledronic acid Teva Pharma been approved?

The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta. Therefore, the CHMP’s view was that, as for Aclasta, the benefit outweighs the identified risk. The Committee recommended that Zoledronic acid Teva Pharma be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Pharma?

A risk management plan has been developed to ensure that Zoledronic acid Teva Pharma is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Zoledronic acid Teva Pharma

The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Pharma on 16 August 2012.

For more information about treatment with Zoledronic acid Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zoledronic acid Teva Pharma : EPAR - Summary for the public BG = bălgarski 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public ES = español 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public CS = čeština 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public DA = dansk 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public DE = Deutsch 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public ET = eesti keel 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public EL = elliniká 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public EN = English 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public FR = français 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public IT = italiano 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public LV = latviešu valoda 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public LT = lietuvių kalba 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public HU = magyar 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public MT = Malti 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public NL = Nederlands 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public PL = polski 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public PT = português 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public RO = română 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public SK = slovenčina 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public SL = slovenščina 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public FI = suomi 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public SV = svenska 28/08/2012 02/07/2015
Zoledronic acid Teva Pharma : EPAR - Summary for the public HR = Hrvatski 28/08/2012 02/07/2015

This EPAR was last updated on 27/01/2016 .

Authorisation details

Product details

Product details for Zoledronic acid Teva Pharma
NameZoledronic acid Teva Pharma
Agency product numberEMEA/H/C/002437
Active substance

zoledronic acid

International non-proprietary name (INN) or common name

zoledronic acid

Therapeutic area Osteoporosis, PostmenopausalOsteoporosisOsteitis Deformans
Anatomical therapeutic chemical (ATC) code M05BA08
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Zoledronic acid Teva Pharma
Marketing-authorisation holder

Teva B.V.

Revision9
Date of issue of marketing authorisation valid throughout the European Union16/08/2012

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

14/12/2015  Zoledronic acid Teva Pharma -EMEA/H/C/002437 -IAIN/0013

Name Language First published Last updated
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016
Zoledronic acid Teva Pharma : EPAR - Product Information HR = Hrvatski 28/08/2012 27/01/2016

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.


Name Language First published Last updated
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013
Zoledronic acid Teva Pharma : EPAR - All Authorised presentations HR = Hrvatski 28/08/2012 20/08/2013

Name Language First published Last updated
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  
Zoledronic acid Teva Pharma : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 28/08/2012  

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Zoledronic acid Teva Pharma : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 20/08/2013 27/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Zoledronic acid Teva Pharma : EPAR - Public assessment report HR = Hrvatski 28/08/2012  
CHMP summary of positive opinion for Zoledronic acid Teva Pharma HR = Hrvatski 16/03/2012  

Authorised

This medicine is approved for use in the European Union

More information on Zoledronic acid Teva Pharma