- 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Public Assessment Report for Rilonacept Regeneron is updated to reflect the fact that the marketing authorisation is no longer valid.
Product information
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).
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
ImmunosuppressantsTherapeutic 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.