Xaluprine (previously Mercaptopurine Nova Laboratories)

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mercaptopurine

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

Overview

This is a summary of the European public assessment report (EPAR) for Xaluprine. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xaluprine.

This EPAR was last updated on 28/07/2017

Authorisation details

Product details
Name
Xaluprine (previously Mercaptopurine Nova Laboratories)
Agency product number
EMEA/H/C/002022
Active substance
6-mercaptopurine monohydrate
International non-proprietary name (INN) or common name
mercaptopurine
Therapeutic area (MeSH)
Leukemia, Lymphoid
Anatomical therapeutic chemical (ATC) code
L01BB02
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
Nova Laboratories Ltd
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
09/03/2012
Contact address
Martin House
Gloucester Crescent
Wigston
Leicester LE18 4YL
United Kingdom

Product information

13/07/2017 Xaluprine (previously Mercaptopurine Nova Laboratories) - EMEA/H/C/002022 - PSUSA/00001988/201609

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

Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.

Assessment history

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