Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: GILENYA   
Auth. number : EU/1/11/677
Active substance : Fingolimod
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA27 - Fingolimod
(See WHO ATC Index)
Indication: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

- Patients with high disease activity despite treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1).
These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of at least one disease modifying therapy. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Marketing Authorisation Holder: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2202 (2011)1890 of 17/03/2011
22/03/2011 Centralised - Authorisation EMEA/H/C/2202 (2011)1889 of 17/03/2011
28/04/2011 Centralised - Variation EMEA/H/C/2202/IA/1/G
Updated with Decision(2011)9738 of 14/12/2011
10/10/2011 Centralised - Variation EMEA/H/C/2202/IG/109
Updated with Decision(2011)9738 of 14/12/2011
19/12/2011 Centralised - Variation EMEA/H/C/2202/II/2 (2011)9736 of 14/12/2011
20/12/2011 Centralised - Variation EMEA/H/C/2202/II/2 (2011)9738 of 14/12/2011
10/02/2012 Centralised - Notification EMEA/H/C/2202/N/7
Updated with Decision(2012)4265 of 18/06/2012
20/06/2012 Referral EMEA/H/C/2202/A-20/8 (2012)4266 of 18/06/2012
22/06/2012 Referral EMEA/H/C/2202/A-20/8 (2012)4265 of 18/06/2012
07/11/2012 Centralised - Variation EMEA/H/C/2202/IB/14
Updated with Decision(2013)8506 of 25/11/2013
26/11/2012 Centralised - Variation EMEA/H/C/2202/II/10 (2012)8703 of 22/11/2012
13/12/2012 Centralised - Variation EMEA/H/C/2202/II/13
Updated with Decision(2013)8506 of 25/11/2013
21/02/2013 Centralised - Variation EMEA/H/C/2202/II/12
Updated with Decision(2013)8506 of 25/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/2202/II/15
Updated with Decision(2013)8506 of 25/11/2013
24/10/2013 Centralised - Variation EMEA/H/C/2202/II/19
Updated with Decision(2013)8506 of 25/11/2013
27/11/2013 Centralised - Variation EMEA/H/C/2202/II/20 (2013)8506 of 25/11/2013
23/12/2013 PSUSA - Modification EMEA/H/C/2202/PSUV/23 (2013)9760 of 18/12/2013
10/02/2014 Corrigendum (2014)790 of 06/02/2014
20/03/2014 Centralised - Variation EMEA/H/C/2202/II/25
Updated with Decision(2014)3620 of 23/05/2014
20/03/2014 Centralised - Variation EMEA/H/C/2202/II/24
Updated with Decision(2014)3620 of 23/05/2014
28/03/2014 Centralised - Variation EMEA/H/C/2202/IB/28
Updated with Decision(2014)3620 of 23/05/2014
27/05/2014 Centralised - 2-Monthly update EMEA/H/C/2202/II/21 (2014)3620 of 23/05/2014
23/06/2014 PSUSA - Modification EMEA/H/C/2202/PSUV/27 (2014)4280 of 19/06/2014
24/07/2014 Centralised - Variation EMEA/H/C/2202/II/26/G
02/03/2015 Centralised - Variation EMEA/H/C/2202/IAIN/31