Zoledronic acid Actavis

zoledronic acid

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

What is Zoledronic acid Actavis?

Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg). It is available as a concentrate to be made into a solution for infusion (drip) into a vein.

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

What is Zoledronic acid Actavis used for?

Zoledronic acid Actavis can be used to prevent bone complications in adults with advanced cancer that is affecting the bone. This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood). Zoledronic acid Actavis can also be used to treat the hypercalcaemia caused by tumours.

The medicine can only be obtained with a prescription.

How is Zoledronic acid Actavis used?

Zoledronic acid Actavis must only be used by a doctor who has experience in the use of this type of medicine given into a vein.

The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes. When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys. It is not recommended for patients with severe kidney problems.

How does Zoledronic acid Actavis work?

The active substance in Zoledronic acid Actavis, 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. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

Patients with tumours can have high levels of calcium in their blood, released from the bones. By preventing the breakdown of bones, Zoledronic acid Actavis also helps to reduce the amount of calcium released into the blood.

How has Zoledronic acid Actavis been studied?

The company provided data from the published literature on zoledronic acid. No additional studies were needed as Zoledronic acid Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.

What are the benefits and risks of Zoledronic acid Actavis?

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

Why has Zoledronic acid Actavis been approved?

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

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

A risk management plan has been developed to ensure that Zoledronic acid Actavis 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 Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.

Other information about Zoledronic acid Actavis

The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.

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

Name Language First published Last updated
Zoledronic Acid Actavis : EPAR - Summary for the public BG = bălgarski 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public ES = español 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public CS = čeština 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public DA = dansk 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public DE = Deutsch 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public ET = eesti keel 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public EL = elliniká 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public EN = English 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public FR = français 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public IT = italiano 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public LV = latviešu valoda 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public LT = lietuvių kalba 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public HU = magyar 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public MT = Malti 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public NL = Nederlands 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public PL = polski 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public PT = português 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public RO = română 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public SK = slovenčina 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public SL = slovenščina 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public FI = suomi 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public SV = svenska 2012-05-07 2016-06-16
Zoledronic Acid Actavis : EPAR - Summary for the public HR = Hrvatski 2012-05-07 2016-06-16

This EPAR was last updated on 23/09/2016 .

Authorisation details

Product details

Product details for Zoledronic acid Actavis
NameZoledronic acid Actavis
Agency product numberEMEA/H/C/002488
Active substance

zoledronic acid monohydrate

International non-proprietary name (INN) or common name

zoledronic acid

Therapeutic area Fractures, Bone
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 Actavis
Marketing-authorisation holder

Actavis Group PTC ehf  

Revision9
Date of issue of marketing authorisation valid throughout the European Union20/04/2012

Contact address:

Actavis Group PTC ehf 
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

Product information

07/07/2016  Zoledronic acid Actavis -EMEA/H/C/002488 -IB/0016

Name Language First published Last updated
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23
Zoledronic acid Actavis : EPAR - Product Information HR = Hrvatski 2012-05-07 2016-09-23

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 Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  
Zoledronic acid Actavis : EPAR - All Authorised presentations HR = Hrvatski 2012-05-07  

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. 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zoledronic acid Actavis : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2013-06-25 2016-09-23

Initial marketing-authorisation documents

Name Language First published Last updated
Zoledronic acid Actavis : EPAR - Public assessment report HR = Hrvatski 2012-05-07  
CHMP summary of positive opinion for Zoledronic acid Actavis HR = Hrvatski 2012-02-17  

Authorised

This medicine is approved for use in the European Union

More information on Zoledronic acid Actavis