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.

Zoledronic acid medac is a medicine that contains the active substance zoledronic acid. It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.

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

Zoledronic acid medac 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 medac can also be used to treat the hypercalcaemia caused by tumours.

The medicine can only be obtained with a prescription.

Zoledronic acid medac 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 medac 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.

The active substance in Zoledronic acid medac, 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 medac also helps to reduce the amount of calcium released into the blood.

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

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

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

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

In addition, the company that markets Zoledronic acid medac 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.

The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.

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

Zoledronic acid Medac : EPAR - Summary for the public

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Product information

Zoledronic acid Medac : EPAR - Product Information

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Latest procedure affecting product information: IB/0030

23/09/2020

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Zoledronic acid Medac : EPAR - All Authorised presentations

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Product details

Name of medicine
Zoledronic acid medac
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

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).

Authorisation details

EMA product number
EMEA/H/C/002359

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.

Marketing authorisation holder
medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstrasse 6
22880 Wedel
Germany

Opinion adopted
24/05/2012
Marketing authorisation issued
03/08/2012
Revision
13

Assessment history

Zoledronic acid medac : EPAR - Procedural steps taken and scientific information after authorisation

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Zoledronic acid medac-H-C-PSUSA-3149-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

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Zoledronic acid medac-H-C-PSUSA-00003149-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

English (EN) (70.27 KB - PDF)View

Zoledronic acid Medac : EPAR - Public assessment report

English (EN) (178.6 KB - PDF)View

CHMP positive summary of opinion for Zoledronic acid medac

English (EN) (59.45 KB - PDF)View
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