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 24/01/2022

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
OrphanOrphan

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
Helsinn Birex Pharmaceuticals Ltd.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
03/03/2017
Contact address

Damastown
Mulhuddart
Dublin 15
Ireland

Product information

07/01/2022 Ledaga - EMEA/H/C/002826 - R/0030

Other EU languages available icon 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:

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

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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