Mavenclad
cladribine
Table of contents
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.
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 |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
22/08/2017
|
Contact address |
Product information
07/01/2020 Mavenclad - EMEA/H/C/004230 - IB/0012
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