Overview

The marketing authorisation for Lifmior has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

Lifmior : EPAR - Summary for the public

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polski (PL) (741.21 KB - PDF)

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português (PT) (666.39 KB - PDF)

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română (RO) (690.8 KB - PDF)

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slovenčina (SK) (742.1 KB - PDF)

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slovenščina (SL) (732.49 KB - PDF)

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Suomi (FI) (663.73 KB - PDF)

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svenska (SV) (664.65 KB - PDF)

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Product information

Lifmior : EPAR - Product Information

English (EN) (3.25 MB - PDF)

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български (BG) (1.91 MB - PDF)

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español (ES) (2.41 MB - PDF)

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čeština (CS) (5.68 MB - PDF)

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dansk (DA) (2.39 MB - PDF)

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Deutsch (DE) (2.62 MB - PDF)

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eesti keel (ET) (2.4 MB - PDF)

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ελληνικά (EL) (7.56 MB - PDF)

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français (FR) (2.48 MB - PDF)

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hrvatski (HR) (2.39 MB - PDF)

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íslenska (IS) (2.46 MB - PDF)

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italiano (IT) (2.48 MB - PDF)

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latviešu valoda (LV) (5.91 MB - PDF)

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lietuvių kalba (LT) (2.49 MB - PDF)

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magyar (HU) (5.66 MB - PDF)

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Malti (MT) (6.04 MB - PDF)

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Nederlands (NL) (2.59 MB - PDF)

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polski (PL) (6.08 MB - PDF)

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português (PT) (2.45 MB - PDF)

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română (RO) (2.51 MB - PDF)

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slovenčina (SK) (5.59 MB - PDF)

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slovenščina (SL) (5.44 MB - PDF)

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Suomi (FI) (2.45 MB - PDF)

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svenska (SV) (3.58 MB - PDF)

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Latest procedure affecting product information: IG/1082

05/04/2019

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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).

Lifmior : EPAR - All Authorised presentations

English (EN) (610.51 KB - PDF)

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български (BG) (691.52 KB - PDF)

First published: 13/03/2017Last updated: 20/02/2020
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español (ES) (609.6 KB - PDF)

First published: 13/03/2017Last updated: 20/02/2020
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čeština (CS) (645.81 KB - PDF)

First published: 13/03/2017Last updated: 20/02/2020
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dansk (DA) (609.53 KB - PDF)

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Deutsch (DE) (610.23 KB - PDF)

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eesti keel (ET) (606.97 KB - PDF)

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ελληνικά (EL) (653.99 KB - PDF)

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français (FR) (607.67 KB - PDF)

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hrvatski (HR) (608.61 KB - PDF)

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íslenska (IS) (608.15 KB - PDF)

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italiano (IT) (612.85 KB - PDF)

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latviešu valoda (LV) (647.79 KB - PDF)

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lietuvių kalba (LT) (612.9 KB - PDF)

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magyar (HU) (659.6 KB - PDF)

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Malti (MT) (647.64 KB - PDF)

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Nederlands (NL) (608.44 KB - PDF)

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norsk (NO) (608.34 KB - PDF)

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polski (PL) (644.9 KB - PDF)

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português (PT) (612.87 KB - PDF)

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română (RO) (613.7 KB - PDF)

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slovenčina (SK) (644.63 KB - PDF)

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slovenščina (SL) (639.96 KB - PDF)

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Suomi (FI) (606.43 KB - PDF)

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svenska (SV) (613.33 KB - PDF)

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Product details

Name of medicine
Lifmior
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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/H/C/004167
Marketing authorisation holder
Pfizer Europe MA EEIG

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Opinion adopted
15/12/2016
Marketing authorisation issued
13/02/2017
Revision
8

Assessment history

Lifmior : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (902.1 KB - PDF)

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Lifmior-H-C-4167- WS1362 : EPAR - Assessment Report

Reference Number: EMA/366395/2018

English (EN) (780.44 KB - PDF)

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Lifmior : EPAR - Public assessment report

AdoptedReference Number: EMA/114647/2016

English (EN) (957.47 KB - PDF)

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CHMP summary of positive opinion for Lifmior

AdoptedReference Number: EMA/CHMP/764586/2016

English (EN) (722.23 KB - PDF)

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More information on Lifmior

Public statement on Lifmior: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/66704/2020

English (EN) (136.75 KB - PDF)

First published:
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