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.
Kineret : EPAR - Medicine overview (PDF/85.64 KB)
First published: 26/01/2009
Last updated: 15/05/2018
Kineret : EPAR - Risk-management plan summary (PDF/89.48 KB)
First published: 30/04/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Swedish Orphan Biovitrum AB (publ)
|Date of issue of marketing authorisation valid throughout the European Union||
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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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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 201823/02/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 201320/09/2013
Public statement on the increased risk of serious infection and neutropenia in patients trested concurrently with Kineret (anakinra) and Enbrel (etanercept)05/02/2003