Rilonacept Regeneron (previously Arcalyst)

rilonacept

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The marketing authorisation for Rilonacept Regeneron has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Rilonacept Regeneron : EPAR - Summary for the public BG = bălgarski 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public ES = español 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public CS = čeština 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public DA = dansk 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public DE = Deutsch 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public ET = eesti keel 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public EL = elliniká 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public EN = English 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public FR = français 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public IT = italiano 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public LV = latviešu valoda 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public LT = lietuvių kalba 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public HU = magyar 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public MT = Malti 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public NL = Nederlands 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public PL = polski 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public PT = português 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public RO = română 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public SK = slovenčina 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public SL = slovenščina 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public FI = suomi 2009-11-12 2010-09-24
Rilonacept Regeneron : EPAR - Summary for the public SV = svenska 2009-11-12 2010-09-24

This EPAR was last updated on 30/10/2012 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Rilonacept Regeneron (previously Arcalyst)
NameRilonacept Regeneron (previously Arcalyst)
Agency product numberEMEA/H/C/001047
Active substance

rilonacept

International non-proprietary name (INN) or common name

rilonacept

Therapeutic area Cryopyrin-associated Periodic Syndromes
Anatomical therapeutic chemical (ATC) code L04AC08
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Rilonacept Regeneron (previously Arcalyst)
Marketing-authorisation holder

Regeneron UK Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union23/10/2009

Contact address:

Regeneron UK Limited
40 Bank Street
London
E14 5DS
United Kingdom

Product information

Product information

28/06/2012  Rilonacept Regeneron (previously Arcalyst) -EMEA/H/C/001047 -S/0006

Name Language First published Last updated
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24
Rilonacept Regeneron : EPAR - Product Information SV = svenska 2009-11-12 2012-09-24

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.

Name Language First published Last updated
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Rilonacept Regeneron: EPAR - All Authorised presentations SV = svenska 2009-11-12 2010-09-24
Name Language First published Last updated
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 2009-11-12  

Pharmacotherapeutic group

Immunosuppressants

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Rilonacept Regeneron : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-07-06 2012-09-24
CHMP post-authorisation summary of positive opinion for Arcalyst SV = svenska 2009-07-23  

Initial marketing-authorisation documents

Name Language First published Last updated
Rilonacept Regeneron : EPAR - Public assessment report SV = svenska 2009-11-12  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Rilonacept Regeneron