Ferriprox

RSS

deferiprone

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

Overview

This is a summary of the European public assessment report (EPAR) for Ferriprox. 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 Ferriprox.

This EPAR was last updated on 26/06/2019

Authorisation details

Product details
Name
Ferriprox
Agency product number
EMEA/H/C/000236
Active substance
Deferiprone
International non-proprietary name (INN) or common name
deferiprone
Therapeutic area (MeSH)
  • beta-Thalassemia
  • Iron Overload
Anatomical therapeutic chemical (ATC) code
V03AC02
Publication details
Marketing-authorisation holder
Apotex B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
25/08/1999
Contact address

Keizersgracht 311
1016 EE Amsterdam
Netherlands

Product information

27/05/2019 Ferriprox - EMEA/H/C/000236 - IAIN/0132

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

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

Ferriprox 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 (mainly cardiac overload) justifies rapid or intensive correction.

Assessment history

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