Rilonacept Regeneron (previously Arcalyst)

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Withdrawn

This medicine's authorisation has been withdrawn

rilonacept
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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Public Assessment Report for Rilonacept Regeneron is updated to reflect the fact that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: S/0006
28/06/2012
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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).

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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

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