Rilonacept Regeneron (previously Arcalyst)

Withdrawn

This medicine's authorisation has been withdrawn

rilonacept

Overview

On 23 October 2009 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Rilonacept Regeneron (Rilonacept). Rilonacept Regeneron was approved for the treatment of cryopyrin-associated periodic syndromes (CAPS). 

The marketing authorisation holder (MAH) responsible for Rilonacept Regeneron was Regeneron UK Limited. The European Commission was notified by letter dated 20 September 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Rilonacept Regeneron for commercial reasons. The product had never been placed on the market in any country of the European Community. 

On 24 October 2012 the European Commission issued a decision to withdraw the marketing authorisation for Rilonacept Regeneron. 

Pursuant to this decision the European Public Assessment Report for Rilonacept Regeneron is updated to reflect the fact that the marketing authorisation is no longer valid.

Rilonacept Regeneron : EPAR - Summary for the public

Product information

Rilonacept Regeneron : EPAR - Product Information

Rilonacept Regeneron: EPAR - All Authorised presentations

Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV

Product details

• Name of medicine:
  Rilonacept Regeneron (previously Arcalyst)
• Active substance:
  rilonacept
• International non-proprietary name (INN) or common name:
  rilonacept
• Therapeutic area (MeSH):
  Cryopyrin-Associated Periodic Syndromes
• Anatomical therapeutic chemical (ATC) code:
  L04AC08

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001047
• 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.

• Marketing authorisation holder:
  Regeneron UK Limited

  40 Bank Street; London; E14 5DS; United Kingdom

• Marketing authorisation issued:
  23/10/2009
• Withdrawal of marketing authorisation:
  24/10/2012
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Rilonacept Regeneron : EPAR - Procedural steps taken and scientific information after authorisation

CHMP post-authorisation summary of positive opinion for Arcalyst

Adopted Reference Number: EMEA/CHMP/346815/2009

Initial marketing authorisation documents

Rilonacept Regeneron : EPAR - Public assessment report