Kineret

RSS

anakinra

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

Overview

An overview of Kineret and why it is authorised in the EU

Kineret is a medicine that is used to treat:

  • signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults. It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone;
  • cryopyrin-associated periodic syndromes (CAPS). CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin. This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness. Severe disabilities such as deafness and loss of vision may also occur;
  • Still’s disease, a rare disease causing inflammation of joints as well as rash and fever.

For CAPS and Still’s disease, Kineret is used in patients from 8 months of age and weighing at least 10 kg.

Kineret contains the active substance anakinra.

This EPAR was last updated on 15/05/2018

Authorisation details

Product details
Name
Kineret
Agency product number
EMEA/H/C/000363
Active substance
anakinra
International non-proprietary name (INN) or common name
anakinra
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AC03
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
07/03/2002
Contact address
112 76 Stockholm
Sweden

Product information

05/04/2018 Kineret - EMEA/H/C/000363 - II/0056

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

Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in adults with an inadequate response to methotrexate alone.

Assessment history

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