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
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

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:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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

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

Assessment history

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