Deferiprone Lipomed

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deferiprone

Authorised
This medicine is authorised for use in the European Union.

Overview

Deferiprone Lipomed is an ‘iron chelator’ (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major. This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.

Deferiprone Lipomed is used:

  • on its own, when standard iron chelator treatment cannot be used or is inadequate;
  • in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions requires rapid or intensive correction of iron levels.

Deferiprone Lipomed contains the active substance deferiprone and is a ‘generic medicine’. This means that Deferiprone Lipomed contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Ferriprox.

This EPAR was last updated on 05/10/2018

Authorisation details

Product details
Name
Deferiprone Lipomed
Agency product number
EMEA/H/C/004710
Active substance
Deferiprone
International non-proprietary name (INN) or common name
deferiprone
Therapeutic area (MeSH)
  • Iron Overload
  • beta-Thalassemia
Anatomical therapeutic chemical (ATC) code
V03AC02
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
Lipomed GmbH
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
19/09/2018
Contact address
Hegenheimer Strasse 2
79576 Weil am Rhein
Germany

Product information

26/07/2018 Deferiprone Lipomed - EMEA/H/C/004710 - -

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Pharmacotherapeutic group

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.

Deferiprone Lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.

Assessment history

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