Rilonacept Regeneron (previously Arcalyst)

Withdrawn

This medicine's authorisation has been withdrawn

rilonacept

Overview

The marketing authorisation for Rilonacept Regeneron has been withdrawn at the request of the marketing-authorisation holder.

Rilonacept Regeneron : EPAR - Summary for the public

Product information

Rilonacept Regeneron : EPAR - Product Information

Latest procedure affecting product information: S/0006

28/06/2012

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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

AdoptedReference Number: EMEA/CHMP/346815/2009

Initial marketing authorisation documents

Rilonacept Regeneron : EPAR - Public assessment report