Lifmior

etanercept

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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.

What is Lifmior and what is it used for?

Lifmior is an anti-inflammatory medicine for treating the following diseases:

  • rheumatoid arthritis (a disease causing inflammation of the joints) alone or with methotrexate in adults
  • certain forms of juvenile idiopathic arthritis (inflammation of joints in children and adolescents)
  • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children
  • psoriatic arthritis (psoriasis with inflammation of the joints) in adults
  • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults
  • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.

Lifmior is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough. For detailed information on the use of Lifmior in all conditions, see the summary of product characteristics (also part of the EPAR).

Lifmior is identical to Enbrel, which has been authorised in the EU since 3 February 2000. It contains the active substance etanercept.

How is Lifmior used?

Lifmior is given as an injection under the skin. In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week. In children, the dose will depend on body weight. The patient or carer can give the injection if they have been trained appropriately. For more information, see the package leaflet.

The medicine can only be obtained with a prescription. Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Lifmior is used for.

How does Lifmior work?

The active substance in Lifmior, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor (TNF). This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Lifmior is used to treat. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.

What benefits of Lifmior have been shown in studies?

Several studies have shown that Lifmior is more effective at reducing symptoms of inflammatory conditions than placebo (a dummy treatment) or a comparator medicine.

In rheumatoid arthritis, five studies have been carried out involving around 2,200 patients. Three of these studies in patients who had taken arthritis medicines in the past showed about two-thirds of the patients who received Lifmior had a reduction in symptoms of 20% or more after three months based on a standard rating score (ACR 20). This compared with around a quarter of the patients receiving placebo.

In a fourth study of rheumatoid arthritis patients who had not taken methotrexate before, those receiving 25 mg Lifmior twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months. A fifth study showed that Lifmior on its own or in combination with methotrexate was more effective than methotrexate alone.

Further studies have been carried out in over 2,300 patients with other inflammatory diseases (juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and axial spondyloarthritis). These studies also showed that Lifmior produced a greater improvement in symptoms than placebo after three to four months using various standard rating scores such as ACR, ASAS and PASI.

What is the risk associated with Lifmior?

The most common side effects with Lifmior (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections). Patients developing a serious infection should stop Lifmior treatment. For the full list of all side effects reported with Lifmior, see the package leaflet.

Lifmior must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections. For the full list of restrictions, see the package leaflet.

Why is Lifmior approved?

Lifmior is effective at reducing symptoms in several inflammatory conditions and its side effects are considered manageable. The CHMP therefore concluded that Lifmior’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Lifmior?

The company that markets Lifmior will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lifmior have also been included in the summary of product characteristics and the package leaflet.

Other information about Lifmior

The European Commission granted a marketing authorisation valid throughout the European Union for Lifmior on 13 February 2017.

For more information about treatment with Lifmior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Lifmior : EPAR - Summary for the public BG = bălgarski 2017-03-13  
Lifmior : EPAR - Summary for the public ES = español 2017-03-13  
Lifmior : EPAR - Summary for the public CS = čeština 2017-03-13  
Lifmior : EPAR - Summary for the public DA = dansk 2017-03-13  
Lifmior : EPAR - Summary for the public DE = Deutsch 2017-03-13  
Lifmior : EPAR - Summary for the public ET = eesti keel 2017-03-13  
Lifmior : EPAR - Summary for the public EL = elliniká 2017-03-13  
Lifmior : EPAR - Summary for the public EN = English 2017-03-13  
Lifmior : EPAR - Summary for the public FR = français 2017-03-13  
Lifmior : EPAR - Summary for the public IT = italiano 2017-03-13  
Lifmior : EPAR - Summary for the public LV = latviešu valoda 2017-03-13  
Lifmior : EPAR - Summary for the public LT = lietuvių kalba 2017-03-13  
Lifmior : EPAR - Summary for the public HU = magyar 2017-03-13  
Lifmior : EPAR - Summary for the public MT = Malti 2017-03-13  
Lifmior : EPAR - Summary for the public NL = Nederlands 2017-03-13  
Lifmior : EPAR - Summary for the public PL = polski 2017-03-13  
Lifmior : EPAR - Summary for the public PT = português 2017-03-13  
Lifmior : EPAR - Summary for the public RO = română 2017-03-13  
Lifmior : EPAR - Summary for the public SK = slovenčina 2017-03-13  
Lifmior : EPAR - Summary for the public SL = slovenščina 2017-03-13  
Lifmior : EPAR - Summary for the public FI = suomi 2017-03-13  
Lifmior : EPAR - Summary for the public SV = svenska 2017-03-13  
Lifmior : EPAR - Summary for the public HR = Hrvatski 2017-03-13  

This EPAR was last updated on 13/03/2017 .

Authorisation details

Product details

Product details for Lifmior
NameLifmior
Agency product numberEMEA/H/C/004167
Active substance

etanercept

International non-proprietary name (INN) or common name

etanercept

Therapeutic area Spondylitis, AnkylosingArthritis, PsoriaticPsoriasis
Anatomical therapeutic chemical (ATC) code L04AB01
Additional monitoring

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

Publication details

Publication details for Lifmior
Marketing-authorisation holder

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Revision0
Date of issue of marketing authorisation valid throughout the European Union13/02/2017

Product information

Product information

13/02/2017  Lifmior -EMEA/H/C/004167 --

Name Language First published Last updated
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  
Lifmior : EPAR - Product Information HR = Hrvatski 2017-03-13  

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.


Name Language First published Last updated
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  
Lifmior : EPAR - All Authorised presentations HR = Hrvatski 2017-03-13  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Lifmior : EPAR - Public assessment report HR = Hrvatski 2017-03-13 2017-07-19
CHMP summary of positive opinion for Lifmior HR = Hrvatski 2016-12-16  

Authorised

This medicine is approved for use in the European Union