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Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Rilonacept Regeneron
Auth. number : EU/1/09/582
Active substance : Rilonacept
Orphan market exclusivity for "Treatment of cryopirin-associated periodic syndromes (Familial Cold Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID), also known as Chronic Infantile Neurological Cutaneous Articular Syndrome (CINCA)" (based on designation EU/3/07/456) started on 27/10/2009
   10 years of market exclusivity
   This orphan market exclusivity has ended on 26/10/2012
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC04 - rilonacept
(See WHO ATC Index)
Indication: indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older
Marketing Authorisation Holder: Regeneron UK Limited
40 Bank Street, Canary Wharf, London E14 5DS, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/10/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1047 (2009)8378 of 23/10/2009
27/10/2009 Centralised - Authorisation EMEA/H/C/1047 (2009)8377 of 23/10/2009
17/03/2010 Centralised - Variation EMEA/H/C/1047/II/1 (2010)1781 of 15/03/2010
05/08/2010 Centralised - Variation EMEA/H/C/1047/IA/2
Updated with Decision(2011)973 of 11/02/2011
15/02/2011 Centralised - Variation (2011)973 of 11/02/2011
27/07/2011 Centralised - Variation EMEA/H/C/1047/IA/4/G
Updated with Decision(2011)7387 of 12/10/2011
14/10/2011 Centralised - Variation (2011)7387 of 12/10/2011
23/11/2011 Centralised - Annual reassessment EMEA/H/C/1047/S/3 (2011)8646 of 21/11/2011
09/02/2012 Centralised - Variation EMEA/H/C/1047/II/5 (2012)822 of 06/02/2012
04/07/2012 Centralised - Annual reassessment EMEA/H/C/1047/S/6 (2012)4593 of 28/06/2012
26/10/2012 Centralised - Withdrawal (2012)7680 of 24/10/2012