Litak

RSS

cladribine

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 04/04/2018

Authorisation details

Product details
Name
Litak
Agency product number
EMEA/H/C/000504
Active substance
Cladribine
International non-proprietary name (INN) or common name
cladribine
Therapeutic area (MeSH)
Leukemia, Hairy Cell
Anatomical therapeutic chemical (ATC) code
L01BB04
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
Lipomed GmbH
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
14/04/2004
Contact address
Hegenheimer Strasse 2
D-79576 Weil/Rhein
Germany

Product information

07/03/2018 Litak - EMEA/H/C/000504 - IB/0013

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

Litak is indicated for the treatment of hairy-cell leukaemia.

Assessment history

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