Rilonacept Regeneron (previously Arcalyst)
rilonacept
Table of contents
Overview
The marketing authorisation for Rilonacept Regeneron has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Rilonacept Regeneron (previously Arcalyst)
|
| Agency product number |
EMEA/H/C/001047
|
| 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
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Regeneron UK Limited
|
| Revision |
5
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/10/2009
|
| Contact address | |
Product information
28/06/2012 Rilonacept Regeneron (previously Arcalyst) - EMEA/H/C/001047 - S/0006
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.