Deferiprone Lipomed
deferiprone
Table of contents
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.
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Deferiprone Lipomed : EPAR - Medicine overview (PDF/100.19 KB)
First published: 05/10/2018
EMA/553501/2018 -
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Deferiprone Lipomed : EPAR - Risk-management-plan summary (PDF/273.11 KB)
First published: 05/10/2018
Authorisation details
Product details | |
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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) |
|
Anatomical therapeutic chemical (ATC) code |
V03AC02
|
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 | |
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Marketing-authorisation holder |
Lipomed GmbH
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
19/09/2018
|
Contact address |
Hegenheimer Strasse 2 |
Product information
08/06/2022 Deferiprone Lipomed - EMEA/H/C/004710 - IB/0010
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.