Mavenclad

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) for Mavenclad. 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 Mavenclad.

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

This EPAR was last updated on 08/08/2018

Authorisation details

Product details
Name
Mavenclad
Agency product number
EMEA/H/C/004230
Active substance
Cladribine
International non-proprietary name (INN) or common name
cladribine
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AA40
Publication details
Marketing-authorisation holder
Merck Europe B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
21/08/2017
Contact address
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands

Product information

09/07/2018 Mavenclad - EMEA/H/C/004230 - T/0004

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

Immunosuppressants

Therapeutic indication

Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features

Assessment history

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