Ledaga

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chlormethine

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

Overview

This is a summary of the European public assessment report (EPAR) for Ledaga. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ledaga.

For practical information about using Ledaga, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 24/01/2018

Authorisation details

Product details
Name
Ledaga
Agency product number
EMEA/H/C/002826
Active substance
Chlormethine
International non-proprietary name (INN) or common name
chlormethine
Therapeutic area (MeSH)
Mycosis Fungoides
Anatomical therapeutic chemical (ATC) code
L01AA05
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Actelion Registration Ltd.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
03/03/2017
Contact address
Chiswick Tower
13th Floor 389
Chiswick High Road
London W4 4AL
United Kingdom

Product information

20/11/2017 Ledaga - EMEA/H/C/002826 - IG/0839

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.

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

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

Assessment history

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