Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Fycompa   
Auth. number : EU/1/12/776
Active substance : Perampanel
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX22 - Perampanel
(See WHO ATC Index)
Indication: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
Marketing Authorisation Holder: Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, 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
25/07/2012 Centralised - Authorisation EMEA/H/C/2434 (2012)5340 of 23/07/2012
27/09/2012 Centralised - Variation EMEA/H/C/2434/IB/3/G
Updated with Decision(2012)7854 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7854 of 29/10/2012
14/11/2012 Centralised - Variation EMEA/H/C/2434/IB/4
Updated with Decision(2013)8064 of 13/11/2013
31/01/2013 Centralised - Notification EMEA/H/C/2434/N/5
Updated with Decision(2013)8064 of 13/11/2013
15/11/2013 PSUSA - Modification EMEA/H/C/2434/PSUV/9 (2013)8064 of 13/11/2013
15/09/2014 Centralised - Variation EMEA/H/C/2434/IB/15