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The marketing authorisation for Rilonacept Regeneron has been withdrawn at the request of the marketing-authorisation holder.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
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.
Assessment history
Rilonacept Regeneron : EPAR - Public assessment report