Lifmior

RSS

etanercept

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

Overview

This is a summary of the European public assessment report (EPAR) for Lifmior. 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 Lifmior.

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

This EPAR was last updated on 13/09/2018

Authorisation details

Product details
Name
Lifmior
Agency product number
EMEA/H/C/004167
Active substance
etanercept
International non-proprietary name (INN) or common name
etanercept
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AB01
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
13/02/2017
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

23/08/2018 Lifmior - EMEA/H/C/004167 - T/0017

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

  • Rheumatoid arthritis;
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis;
  • Axial spondyloarthritis;
  • Plaque psoriasis;
  • Paediatric plaque psoriasis.

Assessment history

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