Rilonacept Regeneron (previously Arcalyst)
Withdrawn
This medicine's authorisation has been withdrawn
rilonacept
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The marketing authorisation for Rilonacept Regeneron has been withdrawn at the request of the marketing-authorisation holder.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
English (EN) (720.83 KB - PDF)
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български (BG) (431.73 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
español (ES) (558.31 KB - PDF)
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čeština (CS) (610.22 KB - PDF)
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dansk (DA) (560.46 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Deutsch (DE) (562.4 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
eesti keel (ET) (557.77 KB - PDF)
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ελληνικά (EL) (706.33 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
français (FR) (582.58 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
italiano (IT) (562.61 KB - PDF)
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latviešu valoda (LV) (639.76 KB - PDF)
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lietuvių kalba (LT) (590.52 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
magyar (HU) (611.12 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Malti (MT) (660 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Nederlands (NL) (558.55 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
polski (PL) (620.09 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
português (PT) (559.21 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
română (RO) (588.46 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
slovenčina (SK) (616.19 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
slovenščina (SL) (497.45 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Suomi (FI) (560.01 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
svenska (SV) (558.39 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Product information
Rilonacept Regeneron : EPAR - Product Information
English (EN) (493.5 KB - PDF)
First published: Last updated:
български (BG) (1.47 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
español (ES) (773.42 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
čeština (CS) (1.14 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
dansk (DA) (787.15 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
Deutsch (DE) (779.06 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
eesti keel (ET) (745.84 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
ελληνικά (EL) (1.61 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
français (FR) (807.27 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
íslenska (IS) (485.37 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
italiano (IT) (754.21 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
latviešu valoda (LV) (1.25 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
lietuvių kalba (LT) (1.03 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
magyar (HU) (1.19 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
Malti (MT) (1.14 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
Nederlands (NL) (771.71 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
norsk (NO) (521.03 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
polski (PL) (1.21 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
português (PT) (800.2 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
română (RO) (1018.64 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
slovenčina (SK) (1.1 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
slovenščina (SL) (1.12 MB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
Suomi (FI) (808.8 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
svenska (SV) (777.01 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2012
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
English (EN) (217.77 KB - PDF)
First published: Last updated:
български (BG) (308.08 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
español (ES) (431.7 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
čeština (CS) (509.78 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
dansk (DA) (431.7 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Deutsch (DE) (472.64 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
eesti keel (ET) (431.7 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
ελληνικά (EL) (515.27 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
français (FR) (431.9 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
italiano (IT) (431.17 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
latviešu valoda (LV) (511.32 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
lietuvių kalba (LT) (498.69 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
magyar (HU) (509.98 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Malti (MT) (512.66 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Nederlands (NL) (431.33 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
polski (PL) (514.07 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
português (PT) (431.94 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
română (RO) (497.95 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
slovenčina (SK) (510.77 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
slovenščina (SL) (476.32 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Suomi (FI) (431.55 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
svenska (SV) (432.23 KB - PDF)
First published: 12/11/2009Last updated: 24/09/2010
Rilonacept Regeneron: EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (117.54 KB - PDF)
First published: Last updated:
български (BG) (384.73 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
español (ES) (294.12 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
čeština (CS) (364.49 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
dansk (DA) (250.98 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
Deutsch (DE) (296.06 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
eesti keel (ET) (291.4 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
ελληνικά (EL) (317.47 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
français (FR) (250.84 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
italiano (IT) (292.89 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
latviešu valoda (LV) (371.02 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
lietuvių kalba (LT) (354.89 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
magyar (HU) (295.96 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
Malti (MT) (311.88 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
Nederlands (NL) (296.29 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
polski (PL) (309.36 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
português (PT) (310.3 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
română (RO) (357.59 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
slovenčina (SK) (309.75 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
slovenščina (SL) (301.29 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
Suomi (FI) (292.15 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
svenska (SV) (250.29 KB - PDF)
First published: 12/11/2009Last updated: 12/11/2009
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.
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
Rilonacept Regeneron : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (287.01 KB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Arcalyst
AdoptedReference Number: EMEA/CHMP/346815/2009
English (EN) (76.79 KB - PDF)
First published: Last updated:
Rilonacept Regeneron : EPAR - Public assessment report
English (EN) (2.33 MB - PDF)
First published: Last updated:
More information on Rilonacept Regeneron
Public statement on Rilonacept Regeneron: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/695977/2012Summary:
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.
English (EN) (48.05 KB - PDF)
First published: Last updated:
This product was originally designated an orphan medicine on 10 July 2007. Rilonacept Regeneron was withdrawn from the Community register of orphan medicinal products by the European Commission in October 2012 at the time of the withdrawal of the marketing authorisation.
This page was last updated on