Targretin

RSS

bexarotene

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

Overview

An overview of Targretin and why it is authorised in the EU

Targretin is a cancer medicine used for the treatment of the visible signs on the skin of cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin. Targretin is used in patients who have an advanced disease and have had at least one other treatment.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Targretin
Agency product number
EMEA/H/C/000326
Active substance
bexarotene
International non-proprietary name (INN) or common name
bexarotene
Therapeutic area (MeSH)
Lymphoma, T-Cell, Cutaneous
Anatomical therapeutic chemical (ATC) code
L01XX25
Publication details
Marketing-authorisation holder
Eisai GmbH
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
29/03/2001
Contact address

Lyoner StraBe 36
60528 Frankfurt am Main
Deutschland

Product information

17/09/2018 Targretin - EMEA/H/C/000326 - T/0050

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.

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Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.

Assessment history

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