Rilonacept Regeneron (previously Arcalyst)



This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Rilonacept Regeneron has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 30/10/2012

Authorisation details

Product details
Rilonacept Regeneron (previously Arcalyst)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Cryopyrin-Associated Periodic Syndromes
Anatomical therapeutic chemical (ATC) code
Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Regeneron UK Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address
40 Bank Street
E14 5DS
United Kingdom

Product information

27/06/2012 Rilonacept Regeneron (previously Arcalyst) - EMEA/H/C/001047 - S/0006


  • 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

Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.

Assessment history

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