This medicine is authorised for use in the European Union.


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 30/04/2019

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Date of issue of marketing authorisation valid throughout the European Union
Contact address
112 76 Stockholm

Product information

14/03/2019 Kineret - EMEA/H/C/000363 - II/0064/G


  • 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

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Pharmacotherapeutic group


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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